ASIA

CHINA

Notice from the Device Review Center of the State Food and Drug Administration on the release of key points for the functional review of artificial intelligence software for magnetic resonance imaging systems

This review point applies to magnetic resonance (MR) imaging systems using artificial intelligence (AI) technology. According to the currently effective “Medical Device Classification Catalog”, the classification code of this type of product is 06-09, and the management category is Class III. The AI software functions referred to in this review point must run on the MR system and be registered with the MR system as a software component. Some AI software functions are presented in the form of dedicated independent software that runs on the general computing platform (workstation, etc.) of the MR system. If it is registered with the MR system as an accessory, it can be regarded as a software component of the MR system. 

The China Regulatory Authority (NMPA)has issued Notice from the Device Review Center of the State Food and Drug Administration on the release of key points for the functional review of artificial intelligence software for magnetic resonance imaging systems (No. 36, 2023)

Their view point mentioned in the notice applies to magnetic resonance (MR) imaging systems using artificial intelligence (AI) technology. According to the current effective “Medical Device Classification Catalog”, the classification code of this type of product is 06-09, and the management category is Class III. The AI software functions referred to in this review point must run  on  the  MR  system  and  be registered  with the MR system as a software component. Some AI software functions are presented in the form of dedicated independent software that runs on the general computing platform (workstation, etc.) of the MR system. If it is registered with the MR system as an accessory, it can be regarded as a software component of the MR system

Notice on publicly soliciting opinions on two industry standards including the “Quality and Technical Specifications for Clinical Trials of Medical Devices”

This standard covers the entire process of pre-market clinical trials of medical devices, including the design, implementation, monitoring and auditing of medical device clinical trials. Check, inspect and collect, record, save, analyze, summarize and report data, etc. This standard defines the protocol design, implementation, and implementation of clinical trials conducted to evaluate the clinical performance and safety of in vitro diagnostic (IVD) reagents. Quality and technical specifications for monitoring, auditing, inspection, and data collection, recording, preservation, analysis, summary, and reporting. The purpose of clinical trials is to evaluate the use of in vitro diagnostic reagents by intended users in the intended use environment, and to target the acquisition and acceptance of the target population.

Announcement of the State Food and Drug Administration on the release of 4 information standards including the “Basic Data Set for Medical Device Registration and Filing Management”

This document specifies the data set classification, data item description, medical device registration management data subset and filing management data subset involved in medical device and in vitro diagnostic reagent registration and filing management. This document specifies the identifier, Chinese name, short name, definition, data type, representation format, allowed value, measurement unit, version and source of data elements related to the registration and filing of medical devices (including in vitro diagnostic reagents) in drug regulatory information. This document specifies the data element value field codes for the registration and filing information of medical devices (including in vitro diagnostic reagents) in drug regulatory information. This document applies to the representation, exchange, identification and processing of information related to medical devices (including in vitro diagnostic reagents) in the field of drug supervision.

Notice of the Center for Device Evaluation of the State Food and Drug Administration on the release of the guidelines for the clinical evaluation and registration review of the same type of laser therapy equipment (2023 No. 28)

In order to further standardize the management of medical devices for laser therapy equipment, the Center for Device Evaluation of the State Food and Drug Administration organized the formulation of the “Guidelines for the Clinical Evaluation and Registration Review of the Same Type of Laser Therapy Devices” This guideline applies to laser treatment equipment for reducing human hair, reducing wrinkles, for the treatment of hyper pigmented skin diseases and skin vascular diseases, and for scar treatment (classification code is 09-03-01, and the management category is Class III). Picosecond laser therapy devices are excluded from this guidance.

Announcement of the Center for Device Evaluation of the State Food and Drug Administration on releasing the guidelines for the clinical evaluation and registration review of the same type of hip prosthesis (No. 27, 2023)

In order to further standardize the management of hip prosthesis medical devices, the Center for Device Evaluation of the State Food and Drug Administration organized the formulation of the “Guidelines for the Clinical Evaluation and Registration Review of the Same Type of Hip Prosthesis”. According to the current “Medical Device Classification Catalog”, the hip prosthesis classification code is 13-04-01, and the management category is Class III. A conventionally designed hip prosthesis usually consists of an acetabular cup, an acetabular liner, a femoral head, and a femoral stem. Compared with the domestically marketed hip joint prosthesis, if the declared product has completely new technical features (such as adopting a new working principle, technology, material, structural design, surface treatment, etc.), or has a new scope of clinical application, the existing If the data cannot prove that the product to be declared is safe and effective, clinical trials may be considered to obtain clinical data.

Notice of the Center for Device Evaluation of the State Food and Drug Administration on the release of the guidelines for the registration review of 4 medical device products including extracorporeal membrane oxygenation (ECMO) temperature control equipment (2023 No. 26)

In order to standardize the registration declaration and technical review of some active products, the Center for Device Evaluation of the State Food and Drug Administration organized the formulation of 4 guiding principles including the “Guidelines for the Registration and Review of Extracorporeal Membrane Oxygenation (ECMO) Temperature Control Equipment”.

According to the product function and intended use, the ECMO temperature control equipment is mainly used to adjust and maintain the temperature of the liquid in the extracorporeal circulation circuit, and cooperate to realize long-term cardiopulmonary function support. Heat exchange equipment intended to be used in extracorporeal cardiopulmonary bypass procedures is implemented in accordance with this guideline. Mobile ECG atrial fibrillation detection products refer to medical devices that identify atrial fibrillation events and give prompts by analyzing ECG data collected by mobile devices.

Administration on releasing 4 review points including the technical review points of imaging ultrasound artificial intelligence software (process optimization functions) (No. 23, 2023)

This review point is applicable to the registration of artificial intelligence software functions for process optimization in imaging and ultrasound products (hereinafter referred to as “ultrasound process optimization AI functions”). The above functions should be used by doctors with corresponding ultrasound diagnosis qualification and ability. The above functions are usually integrated in imaging and ultrasound equipment, and its product classification follows the imaging and ultrasound equipment. According to the current “Medical Device Classification Catalog”, the classification code of this type of product is 06-07, and the management category is Class II or III; if the above functions Integrated in independent software, the classification code is 21-02, based on the “Guidelines for the Classification and Definition of Artificial Intelligence Medical Devices”, as a process optimization function, the management category is Class II. Products used in medical institutions and/or medical laboratories can assist pathologists in providing information for disease diagnosis, prognosis, treatment, etc., and cannot be used as the only basis for clinical diagnosis decisions.

Announcement of the Center for Device Evaluation of the State Food and Drug Administration on the release of guidelines for the registration and review of 14 medical device products including blood melting equipment (No. 22, 2023)

The guideline applies to equipment that thaws clinical blood components. According to the “Medical Device Classification Catalog”, the product management category is Class II, and the classification code is 10-01-06. This guideline is only applicable to equipment that adopts the principle of constant temperature water thawing, and does not apply to thawing equipment based on the principles of microwave oven method, radio frequency method, and dry hot air method. The thawing part of the cryoprecipitated coagulation factor equipment can refer to this guideline, and the preparation part is not applicable. The medical respiratory humidifier referred to in this guideline is a medical electrical device used to humidify the respiratory gas delivered to the patient, usually used in conjunction with respiratory therapy equipment, and generally consists of a main unit, a water storage tank and some accessories. Currently, some respiratory therapy devices also integrate humidifiers, such as sleep apnea therapy devices and high-flow respiratory therapy devices. This guideline also applies to the humidifier portion of these devices.

Notice of the Center for Device Evaluation of the State Food and Drug Administration on the release of the guidelines for the clinical evaluation and registration review of the same variety of intervertebral fusion devices (2023 No. 20)

According to the current “Medical Device Classification Catalog”, the classification code of this type of product is 13-03-04, and the management category is Class III. The base material of the intervertebral cage is usually titanium and titanium alloy materials that comply with GB/T13810, and the grades are generally TA2G, TA3G, TC4 (Ti6Al4V), TC20 (Ti6Al7Nb), TC4 ELI (Ti6Al4V ELI), or YY / T The surgical implant of the 0660 is made of polyetheretherketone (PEEK) polymer. The developing wire is usually made of pure tantalum in accordance with YY/T 0966 or titanium and titanium alloy materials in GB/T 13810. 

This guideline does not include artificial vertebral bodies, new materials, specially designed intervertebral fusion devices and custom made intervertebral fusion devices, etc. intervertebral fusion devices that have been marketed in China, if the declared product has brand new technical features (such as adopting a new working principle, technology, material, structural design, surface treatment, etc.), or has a new scope of clinical application If the existing data cannot prove that the declared product is safe and effective, clinical trials may be considered to obtain clinical data. 

Supervision overview of artificial intelligence medical devices

The industry of intelligent medical device products is a highly regulated industry, and the evaluation of product safety and effectiveness is relatively cautious. In particular, the technology represented by artificial intelligence is essentially a black-box algorithm driven by massive data, which has the characteristics of fast update and iteration, and brings many challenges to supervision. Regulatory agencies at home and abroad have issued a series of policies to strengthen the supervision of artificial intelligence medical devices. The US Food and Drug Administration (FDA) believes that the traditional medical device approval process is difficult to apply to artificial intelligence medical devices, so it has issued a series of documents and guidelines to guide regulatory reform and innovation. In June 2019, the FDA released the “Proposed Regulatory Framework for Amendments to AI/ML-Based SaMD”, proposing a regulatory framework for the full life cycle of artificial intelligence medical devices.

Notice of the General Affairs Department of the State Food and Drug Administration on printing and distributing the “Appendix to the Medical Device Operation Quality Management Regulations: Guiding Principles for Quality Management On-site Inspection of Enterprises Specially Providing Medical Device Transportation and Storage Services” (Drug Administration Comprehensive Equipment Management [2023] No. 44)

The “Guiding Principles” are applicable to the on-site inspection by the drug supervision and management department of the business license (including change and continuation) or business filing of enterprises specializing in the transportation and storage of medical devices, as well as the daily supervision and inspection of such enterprises. During the inspection, the enterprise shall inspect the implementation of the “Appendix to the Specification” in accordance with the inspection items in the “Guiding Principles” and the corresponding key inspection contents. Enterprises that specialize in providing medical device transportation and storage services can determine reasonable missing items based on their business scope, business varieties, etc., and explain the reasons in writing, which will be confirmed by the inspection team.

Notice of the Center for Device Evaluation of the State Food and Drug Administration on the release of the guidelines for the registration and review of two medical device products including recombinant collagen wound dressings (No. 16, 2023)

Recombinant collagen wound dressings managed as Class II medical device, whose structure contains recombinant collagen components (excluding collagen components extracted from animal tissues), and used for non-chronic wounds and their surrounding skin care. Products are usually in the form of gels, liquids, patches, ointments, etc., including single-use products and products that can be used multiple times after opening, and are provided in sterile or non-sterile forms. The ingredients contained in the product do not have pharmacological effects and cannot be absorbed by the human body. If the classification and attributes of the product are not clear, it is necessary to apply for the classification and attribute definition of the product.

Notice on Soliciting Information of Participating Units in the Formulation of Two Guiding Principles for Registration and Review of Medical Device Registration and Review

According to the 2023 guideline preparation plan, to further improve the technical review of related products, our center has started the compilation of the “Guidelines for the Registration and Review of Disposable Indwelling Cannulae” and “The Guidelines for the Registration and Review of Hydrogel Dressing Products”. Participating units in the preparation work are now being recruited, and domestic and foreign production enterprises, scientific research institutions and other relevant units with relevant experience are invited to actively participate.

Notice on Public Solicitation of Opinions on 7 Guiding Principles for Registration and Review of In Vitro Diagnostic Reagents, including “Guidelines for Technical Review of Estrogen Receptor, Progesterone Receptor Antibody Reagents and Detection Kits

The “Guidelines for Technical Review of Estrogen Receptor, Progesterone Receptor Antibody Reagents and Detection Kits” has now been launched. It is hoped that the production enterprises that have relevant product development, production or registration declarations will actively participate in the revision of the 7 guiding principles. In order to facilitate contact and communication, information on relevant production enterprises is now collected from domestic and overseas.

Announcement of the Center for Device Evaluation of the State Food and Drug Administration on Issuing the Guidelines for the Registration and Review of Optical Measuring Equipment for Ophthalmology (No. 13, 2023)

In order to further standardize the management of ophthalmic optical measuring equipment, the Center for Device Evaluation of the State Food and Drug Administration organized the revision of the “Guiding Principles for the Registration and Review of Ophthalmic Optical Measuring Equipment”. This guideline applies to diagnostic/ measuring equipment that utilizes optical imaging/measurement principles to obtain ophthalmic biological parameters. The guideline is general requirement for ophthalmic optical measuring equipment. Registration applicants should determine whether the content is applicable based on the specific characteristics of the product.

Notice of the Center for Device Evaluation of the State Food and Drug Administration on the release of the guidelines for the registration review of six medical device products including drug-coated balloon dilatation catheters (No. 9, 2023)

This guideline is applicable to intravascular recovery devices with classification code 03-13-22 in the “Catalogue for Classification of Medical Devices”. For other intravascular retrieval devices, such as vena cava filter retrieval devices, refer to the applicable sections of this guideline. 

The drug-coated balloon dilatation catheter involved in this guideline refers to the drug-coated balloon dilation catheter under the classification code 03-13-06 in the “Medical Device Classification Catalog”, and the management category of this product is Class III. For other products under 03-13-06 that do not fall within the scope of this guideline, or have special designs, or the classification code is not classified under 03-13-06, the registration applicant can refer to the guideline applicable content. 

Notice of the Center for Device Evaluation of the State Food and Drug Administration on the release of the guidelines for the registration and review of radio frequency cosmetic devices (No. 8, 2023)

The radio frequency beauty equipment mentioned in this guideline refers to the use of specific frequency radio frequency current (usually above 200kHz) or electric field (usually 13.56 or 40.68MHz) and other electrical energy to act on human tissues to generate thermal effects, so as to achieve skin relaxation, relieve Products that wrinkle the skin, shrink pores, tighten/lift skin tissue, or treat acne, blemishes, or fat reduction (fat softening or breakdown). RF aesthetic devices as covered in this guideline include both stand /table-top (large) devices (typically operating on mains power) and hand-held (small) devices (typically operating on internal power).

Notice of the Center for Device Evaluation of the State Food and Drug Administration on the release of the guidelines for the registration and review of quantitative shear wave ultrasonic hepatometers (No. 7, 2023)

This guideline is applicable to quantitative shear wave ultrasonic liver measuring instrument, which belongs to 07 ultrasonic physiological parameter measurement and analysis equipment under 07 medical diagnosis and monitoring equipment classification according to the “Medical Device Classification Catalog”. The code is 07-07-02, and the management category of the product is three categories. This guideline does not include the content of the ultrasonic image part used to confirm the measurement position, which can be declared with reference to the “Guidelines for Technical Review of Image-based Ultrasound Diagnostic Equipment (Class III)”. The “probe” mentioned below refers to the probe used for hardness measurement. If there are corresponding guiding principles for other functions of the product, they shall also comply with the corresponding guiding principles of the product.

Announcement on the release of the 2023 medical device registration review guidelines compilation plan (No. 6, 2023)

The guiding principles of medical device registration review in the registration application and technical review work, our center has organized the drafting of the compilation plan of the guiding principles of medical device registration review (see the attachment for details), which is now released. It is hoped that relevant manufacturers, industry associations, scientific research institutes and other units in the medical device industry will pay attention to the specific notices or solicitation of opinions on the compilation of various guiding principles of our center, and actively participate in the formulation and revision of the guiding principles for medical device registration review.

Notice of the Center for Device Evaluation of the State Food and Drug Administration on the release of the guidelines for the registration review of two medical device products including dental adhesive products

This applies to dental adhesive products for dental filling restoration and prosthetic restoration bonding. This guideline does not apply to products of special design and innovative design. This guideline applies to artificial shoulder prostheses, which typically include humeral components (e.g., humeral head, humeral stem, humeral liner, humeral socket), glenoid components (e.g., glenoid liner, glenoid socket, glenoid head, fixation Screws), usually made of cobalt chromium molybdenum alloy, titanium alloy, ultra-high molecular weight polyethylene, ceramic materials. This guideline does not include the requirements for specially designed products such as patient-matched personalized artificial shoulder prosthesis, but the applicable parts can refer to the corresponding technical content in this guideline.

Notice on Soliciting Proposals for Pre-approval of Standards of National Medical Device Clinical Evaluation Standardization Technology Units in 2024

In accordance with relevant regulations such as the “National Standard Management Measures”, “Medical Device Standard Management Measures” and “Medical Device Standard Development and Revision Work Management Regulations”, in order to do a good job in the standard formulation work in 2024, we are now openly soliciting the 2024 medical device clinical evaluation field standard forecast Project proposal. Clinical evaluation of medical devices (including clinical trials) and clinical trial quality management and general requirements for in vitro diagnostic reagents, excluding clinical evaluation requirements for specific products. 

Notice of the Center for Device Evaluation of the State Food and Drug Administration on the Release of the Guidelines for the Registration and Review of the Laparoscopic Surgical System Part 1: Surgical Devices (No. 5, 2023)

The surgical instrument in this guideline is the end effector of the porous laparoscopic surgical system, which is installed on the robotic arm and controlled by the system to perform invasive surgical tasks. Surgical instruments covered by this guideline include surgical instruments that do not provide energy to patients and high-frequency surgical instruments (excluding vascular closure devices). Refer to the applicable parts of this guideline for the surgical instruments used in the single-port laparoscopic surgery system and other surgical instruments. This guideline aims to guide registration applicants in the preparation and writing of registration application materials for surgical instruments and high-frequency surgical instruments that do not provide energy to patients (hereinafter referred to as surgical instruments) for laparoscopic surgery systems (hereinafter referred to as surgical systems). At the same time, it also provides a reference for the technical review department to review the registration application materials.

Timelines for additional medical device information are communicated by CMDE.

China’s Center for Medical Device Evaluation (CMDE) has published timelines for submitting additional information when a medical device supplementary information notice is issued.

The timelines are as follows:

Announcement of the State Food and Drug Administration, the National Health Commission and the National Medical Insurance Administration on Doing a Good Job in the Third Batch of Implementing the Unique Identification of Medical Devices (2023 No. 22)

In order to further implement the “Regulations on the Supervision and Administration of Medical Devices”, the “Notice of the General Office of the State Council on Printing and Distributing the Reform Plan for the Treatment of High-value Medical Consumables” and the key tasks of the State Council to deepen the reform of the medical and health system, it is decided to use some second class medical devices as the third The batches of varieties implement the unique identification of medical devices and the relevant matters.

Announcement of the State Food and Drug Administration on Issuing YY/T 1888-2023 “Recombinant Humanized Collagen” Medical Device Industry Standard (2023 No. 14)

The Center for medical device evaluation of china has issued a Standard. YY/T 1888-2023 “Recombinant Humanized Collagen” medical device industry standard has been approved and is now published.

The document specifies the quality control, technical requirements, test methods, stability, biological evaluation, packaging, transportation and storage of recombinant humanized collagen. This document is applicable to the quality control of recombinant humanized collagen that does not contain the amino acid sequence of non-human collagen as raw material for medical devices.

HONG KONG

Technical Reference “Software Medical Devices and Cybersecurity” (TR-007) has been issued

Technical Reference “Software Medical Devices and Cybersecurity” (TR-007) has been issued and takes immediate effect. This document aims to provide more technical details on the software medical device and cybersecurity under MDACS. 

The document focuses on the overview and definition of software MDs

This document aims to provide a definition for:

Technical Reference “Classification of In Vitro Diagnostic Medical Devices (IVDMDs)” (TR-006) has been updated

The updated guidance document describes the principles of IVDMD classification in accordance with the requirements of MDACS.

The purpose of the guidance documents is to

Scope: The document applies to all products that fall within the definition of an IVDMD. An IVDMD is defined as a device which, whether used alone or in combination, is intended by the manufacturer for the in-vitro examination of specimens derived from the human body solely or principally to provide information for diagnostic, monitoring or compatibility purposes. This includes reagents, calibrators, control materials, specimen receptacles, software, and related instruments or apparatus or other articles. Note: International reference materials (e.g. WHO) and materials used for external quality assessment schemes are excluded.

Guidance Notes on Changes for Listed Medical Devices – Guidance Notes: GN-10Technical Reference “Classification of In Vitro Diagnostic Medical Devices (IVDMDs)” (TR-006) has been updated

During the life-cycle of a medical device, changes may take place from time to time. To safeguard public health, the information in the Medical Device Administrative Control System (MDACS), including details of listed medical devices, should be up-to-date. The Local Responsible Person (LRP) has the responsibility to timely inform MDD of any change to the listed medical device. This document aims to assist the LRP in categorising, managing and reporting changes of listed medical devices. It is intended to guide the LRP to differentiate changes to a medical device listed under MDACS and report the changes to MDD accordingly.

The document applies to all medical devices listed under MDACS. It sets out points for consideration by LRP when a listed medical device is in the process of change. Owing to the various possible scenarios for changes made to a device, it is not the intention of this document to describe every permutation and type of change that can occur. The LRP may contact the Medical Devices Division (MDD), for further clarification regarding the specific changes to a listed medical device.

Department of Health to implement a new strategy on procurement of medical devices

The procurement of medical devices (MDs) conducted earlier by the Department of Health (DH), DH will adopt a new strategy on the procurement of MDs starting from 21 June 2023. Under the strategy, DH will give preference to MDs listed under the Medical Device Administrative Control System (MDACS) in the procurement of all applicable MDs.

The new strategy will help to intrinsically ensure that the MDs being purchased by DH will meet the safety, quality and performance requirements comparable to international standard. Furthermore, the safety alert monitoring mechanism and the Medical Device Adverse Event Reporting System of Medical Device Division (MDD) also provide additional protection to the public health. Traders who are interested in submitting bid/ quotation/ tender for the supply of MDs to DH Services are encouraged to apply their Class II/III/IV general MDs or Class B/C/D invitro diagnostic MDs for listing under the MDACS as soon as possible. Application form and guidance notes for listing under MDACS are available on MDD website. 

New Procurement Requirement of the Department of Health for Medical Devices

A pilot run of a new requirement on the procurement of Medical Devices (MD) by the Department of Health (DH) has been implemented with effect from 1st Oct 2022. Under the pilot run, certain MD (including, condoms, lubricants of Class II or above*, auditory evoked potential system, blood glucose meter and blood glucose strip) being purchased for use in the Services of DH should preferably be listed under the Medical Device Administrative Control System (MDACS). Subject to the experience gained from the pilot run, DH will include more MD into the scheme. Traders who are interested to submit bid/ quotation/ tender for the supply of the above MD for DH Services are encouraged to apply their relevant MD for listing under the MDACS as soon as possible. If you are interested to apply your MD for listing under the MDACS.

INDIA

CDSCO has released the Regulation of all Class C & D Medical Devices Under Licensing regime, w.e,f 01.10.2023 as per G.S.R 102E dated 11.02.2020 

In order to regulate all the medical devices, MoHFW has published G.S.R. 102 (E) dated 11.02.2020 for regulation of such devices in phase wise manner. As per the said notification the Class C & D medical devices will be under licensing regime from 01.10.2023. In the meantime, representations from various Associations and Stakeholders have been received by this office, requesting that the business continuity should not be disrupted due to the implementation of licensing regime w.e.f. 01.10.2023 for Class C & D medical devices.

In case, if an existing importer/ manufacturer who is already importing/ manufacturing any of the above said Class C or Class D Medical Devices, has submitted application to Central Licensing Authority, for grant of import /manufacturing licence in respect of the said device(s) under the provisions of Medical Devices Rules, 2017, the said application shall be deemed valid and the importer/manufacturer can continue to import/manufacture the said device(s) up to six months from the date of issue of this order or till the time, the Central Licensing Authority, takes a decision on the said application, whichever is earlier.

MDR_Final G.S.R. 409(E)_Amendment in Rule 18 and 19 for notifying State MDTL

The State Government may, by notification, establish State Medical Devices Testing Laboratory for the purpose of,

(a) testing and evaluation of medical devices; or

(b) to carry out any other function as may be specifically assigned to it.

The State Government may also designate any laboratory having facility for carrying out test and evaluation of medical devices as State Medical Devices Testing Laboratory for the purposes specified.

Provided that no medical devices testing laboratory shall be so designated unless it has been duly accredited by the National Accreditation Body for Testing and Calibration Laboratories.

National medical devices policy, 2023

The Government of India has published plans to streamline the regulation of medical devices as part of its strategy for promoting the sector. Specific plans outlined in the strategy include changes to licensing that are designed to avoid the duplication of efforts and imposition of unnecessary compliance burdens.

The medical devices sector in India is an essential and integral constituent of the Indian healthcare sector. It forms an important pillar in the healthcare delivery system along with healthcare providers, pharmaceuticals and healthcare insurance industry, thereby helping achieve the key objectives of the National Health Policy (NHP), 2017. The medical devices constitute a multi-disciplinary sector, with the following broad classification: (a) Electronic equipment (b) Implants; (c) Consumables and Disposables (d) Surgical instruments and (e) In-Vitro Diagnostic Reagents. Further, there are categories of devices across 24+1 (IVD) sub-categories as per the CDSCO.

Circular for Licensing of Class C & D medical devices

According to the Circular It is pertinent to mention that as per Medical Devices rules (MDR) 2017 manufacturing license of class c and D medical devices the inspection needs to be carried out within 60 days from the date of application by the Medical Device Officers (MDO) of central Licensing Authority (CLA), to ensure the compliance with Fifth schedule of MDR 2017. In order to have smooth transition from mandatory registration to licensing regime, it is suggested that, the manufacturers/importers may apply for grant of manufacturing/import license with all requisite documents and fees as per MDR 2017, through www.cdscomdonline.gov.in portal. The application received will be processed proactively, so that, licensure can be issued within the stipulated time line in order to avoid any disruption of the supply chain of such medical devices and access to the patients.

List of Notified Bodies registered with CDSCO under MDR, 2017

The notified bodies registered with CDSCO under provisions Medical device rules 2017 carry out audit of manufacturing site under the provisions of said rules. In this connection, following Notified bodies have been registered with CDSCO.

JAPAN

System for reporting malfunctions during clinical trials of medical devices (machinery, equipment, etc.)

Reports of defects and adverse events during clinical trials of medical devices (hereinafter referred to as “clinical trial defect reports”) are subject to Notification No. 0709004 of the Director-General of the Pharmaceutical and Food Safety Bureau, Ministry of Health, Labor and Welfare dated July 9, 2004. 23 “Regarding Clinical Trials of Medical Devices” of the “Enforcement of the Law for Partial Revision of the Blood Collection. Blood Donation Agency Control Law” (hereinafter referred to as the “enforcement notice”). Notification No. 0330001 of the PFSB dated March 30, 2010, issued by the Director-General of the Pharmaceutical and Food Safety Bureau, Ministry of Health, Labor and Welfare, “Regarding reports of clinical trial defects, etc. related to machinery and equipment to the Pharmaceuticals and Medical Devices Agency,” indicates how to handle this.

Medical safety measures related to pharmaceuticals and medical devices

The Ministry of Health, Labor and Welfare is promoting various efforts to prevent medical accidents, but it is also possible to change the names, containers, and specifications of pharmaceuticals, medical devices, and other products used in medical settings to those that are less likely to cause medical accidents. The MOHLW believe that it will be one of the preventive measures, and we are proceeding with the construction of a system that will materialize. Based on the discussions at this committee, MOHLW have decided to implement the following measures as measures to prevent medical accidents related to drugs and medical devices. 

MALAYSIA

Second edition guidance document MDA/GD/0063: harmonised borderline products in ASEAN

The guidance document provides the list of borderline products whether they are medical devices or non-medical devices based on their intended purpose as claimed by the manufacturer which is harmonised in ASEAN. The objective intent of the manufacturer regarding the use of a product, process or service as reflected in the specifications, instructions and information provided by the manufacturer.

Products that are difficult to distinguish from a medical device, for example products that might be medicines, cosmetics, food supplements, biocidal products or personal protective equipment. These products are called borderline products until their status of medical device or non-medical device has been decided.

Second edition guidance document MDA/GD/0062: harmonised classification of medical devices in ASEAN

The guidance document provides the harmonised list of risk classification of medical devices including in-vitro diagnostic (IVD) medical devices based on their intended use/purpose as claimed by the manufacturer.

This document shall be read in conjunction with the following documents:

The objective intent of the manufacturer regarding the use of a product, process or service as reflected in the specifications, instructions and information provided by the manufacturer

Announcement: implementation of the use of electronic medical device registration certificate beginning November 1, 2023

The Medical Device Authority (MDA) will implement the use of electronic medical device registration certificates from November 1, 2023.

The establishment can download the device registration certificate medicine from the [email protected]+ system after the application is complete (status complete) and payment of the registration fee has been cleared.

For applications approved before November 1, 2023, the establishment will receive a physical medical device registration certificate such as the existing process and at the same time the electronic medical device registration certificate can be loaded down from the [email protected]+ system. The establishment is required to take a certificate registration of physical medical devices at the MDA office after 7 working days from date of application completion (status complete).

MDA to cease the issuance of certificate of free sale (CFS) for export only medical device

Effective 1st October 2023, the Medical device authority of Malaysia has informed that a Certificate of Free Sale (CFS) will only be issued for registered medical devices, following the announcement made by Chief Executive of MDA during MDA High Performance Project on 7th June 2023.

With this move MDA ceases the issuance of CFS for export only medical devices under the Circular Letter of Medical Device Authority No. 4 Year 2018.

Instead, MDA will issue an Export Certificate for establishment who wishes to export the export only medical device from Malaysia as part of the process to register or import a product into that country. The issuance of Export Certificate is not a mandatory requirement under the Act 737 rather it is a service to facilitate the export of medical devices from Malaysia.

MDA Approach on Expired EC Certificate for New Registration and Re-registration of Medical Device

EC Certificate (CE Marking) pursuant to Directive 90/385/EEC and 93/42/EEC is one of the approval types that is recognised by Medical Device Authority (MDA) for conformity assessment procedure by way of verification process for the purpose of medical device registration in Malaysia. In principal, the certificate shall be valid during the new registration and re-registration submission. However, due to the unpredictable timeline and issues with regards to the transition to the EU MDR, and to ensure continuous supply of the medical device in the market, MDA has taken an approach to allow expired EC Certificate to be used for conformity assessment procedure by way of verification process with the registered CABs if the following conditions are met: i. The devices continue to comply with Directive 90/385/EEC and 93/42/EEC; and ii. There are no significant changes in the design and intended purpose; and iii. The devices do not present an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health. 

Announcement of the transition period for the implementation of the use of electronic medical device registration certificate

The Medical Device Authority (MDA) will implement the use of medical device registration certificates electronically from 2 May 2023. The establishment can download the medical device registration certificate from the [email protected]+ system after the application is completed (status complete). and payment of the registration fee has been cleared.

Both physical and electronic medical device registration certificates can be used for the purpose of importing or placing medical devices in the Malaysian market. The transition period for the use of the physical medical device registration certificate to the electronic medical device registration certificate is until December 31, 2023. During this transition period, the establishment will receive the physical medical device registration certificate according to the existing process and at the same time the electronic medical device registration certificate can be downloaded from the [email protected]+ system. 

The use of electronic medical device registration certificates will be fully implemented from 1 January 2024 and no more physical medical device registration certificates will be issued by MDA.

Medical devices not registered on the market

In order to ensure the safety and security of medical device users in Malaysia, the Medical Device Authority (MDA) continuously carries out market surveillance. Apart from that, MDA also ensures that medical devices available in the Malaysian market are only registered and from licensed sources. All companies including retailers are also reminded not to sell unregistered medical devices to avoid any enforcement action being imposed. The sale or distribution of unregistered medical devices is an offense under Section 5, Medical Devices Act 2012 (Act 737) which may result upon conviction, in a fine not exceeding RM200,000.00 or imprisonment for a period not exceeding three years or both.

Withdrawal of medical device registration (new and re-register) and change of notification application

MDA will withdraw the medical device registration (new and re-register) application and change notification application that has not been completed within 30 working days. However, a transitional period is given to applicant until 1st May 2023 for the full implementation on withdrawal of the medical device registration (new and re-register) application and change notification application. Submission of medical device registration (new and re-register) and change notification application shall be provided with the information, particulars or document as stated in the Medical Device Act 2012 [Act 737], Medical Device Regulations 2012, guidance documents and guidelines which has been provided on the MDA website (portal.mda.gov.my).

Abortion of registration applications (new and renewal) and medical device amendments

MDA will drop medical device registration applications (new and renewed) and incomplete medical device amendment applications within 30 working days. However, a transition period is given to applicants until May 1, 2023 before the abort process for medical device registration applications (new and re-) and incomplete medical device amendment applications is fully implemented. The submission of medical device registration applications (new and renewed) and medical device amendment applications must be accompanied by information.

Incomplete applications will be returned to the establishment to be completed. The applicant must provide the required information or documents within 30 working days. The application will be dropped if: 

However, dropping this application does not affect the establishment’s right to make a new application. Application fees for dropped applications will not be refunded.

Classification of rehabilitation, physiotherapy and speech therapy device

This guidance document provides the classification of a list of products used for rehabilitation, physiotherapy and speech therapy by determining whether they are medical devices or nonmedical devices based on their intended purpose as claimed by the manufacturer. The definition of medical device is legally binding in the Medical Device Act 2012 (Act 737) and it determines the scope of regulatory control of the product. This definition differentiates medical devices and not medical device based on clear indication on mode of action for the product been used for rehabilitation, physiotherapy and speech therapy. 

Notification of custom-made medical device

This guidance document is intended to provide guidance for the requirements of custom made medical devices that are eligible to be exempted under Medical Device (Exemption) Order 2016. This guidance document specifies requirements and notification process for the applicant to obtain the permission from the Authority prior to the importation and/or placing of custom-made medical devices in the market. This document does not cover the medical devices that are patient matched, adaptable or mass-produced and these medical devices shall be registered with the Authority. 

Press release medical device authority (MDA), ministry of health Malaysia MDA introduces its new online payment system BayarNow

Bayar Now is a customer portal and payment gateway application service which provides electronic billings and payments services for all customers under Medical Device Authority (MDA) to provides bank transfer payment solution. Bayar Now is directly integrated into the Government Resource Planning (GRP) Financial System and the transactions will be auto-generated and auto posted on a real time basis. To use BayarNow, customers will receive a link via their registered email once their application is approved by MDA. The BayarNow system enable customers to pay online via Financial Process Exchange (FPX) instead of using bank draft.

Guideline document on how to submit an application for registration of a refurbished medical device

This guideline specifies requirements and application process to register the refurbished medical devices. It covers all registered or unregistered medical devices that are intended to be refurbished. In accordance with this recommendation, refurbished medical equipment must be registered via the Medical Device Centralised Online Application System (MeDC@St). The manufacturer or the authorised representative is in charge of registering a refurbished medical device. Exclusion: This document’s guidelines do not apply to the remanufacturing of medical devices.

Guideline for drug-medical device and medical device-drug combination products

Combination product: A product comprised of two or more regulated components, i.e., drug/device, biological/device, or drug/device/biological, that are physically, chemically, or otherwise combined or mixed and produced as a single entity or Two or more separate products packaged together in a single package or as a unit and comprised of drug and device products, device and biological products. Registration Process of Combination Products The primary agency for registration of combination product is based on the primary mode of action/the principal mechanism of action by which the claimed effect or purpose of the product is achieved.

PAKISTAN

DRAP issued Consolidated Notification for Regulatory Fees

Drug Regulatory Authority of Pakistan (DRAP) issued a consolidated notification of Regulatory fess for various functions and services. This notification is issued under the section (1) of section 20 of the Drug Regulatory Authority of Pakistan Act, 2012 (XX.I of 2012) read with sub-rule (3) of rule 4 of the Drug Regulatory Authority of Pakistan (Fee and Levy) Rules, 2022, and in supersession of all such previous Notifications. The Drug Regulatory Authority of Pakistan with the approval of the Policy Board has specified these regulatory fees. 

SRO 224(I)/2023: Notification of Amendment in the Medical Devices Rules, 2017

The Drug Regulatory Authority of Pakistan is pleased to direct that the following additional amendments to the Medical Devices Rules, 2017, be made in accordance with the Federal Government’s approval, in accordance with the authority granted by section 23 of the Drug Regulatory Authority of Pakistan Act, 2012 (XXI of 2012). In terms of section 36 of the Drug Regulatory Authority of Pakistan Act,2012 (XXI of 2012) and from commencement of these rules, Medical devices be exempted from enlistment and registration requirements under these rules for a specified period mentioned in Notification.

PHILIPPINES

FDA Circular No.2021-002-C || Guidelines on the Regulatory Flexibility for Class B, C and D Medical Devices that are Not Included in the List of Registrable Medical Devices Based on FDA Circular No. 2020-001-A entitled “Amendment to Annex A of FDA Circular No. 2020-001 re: Initial Implementation of Administrative Order NO. 2018-0002 “Guidelines Governing the Issuance of an Authorization for a Medical Device based on the ASEAN Harmonized Technical Requirements”

This issuance shall apply to Class B, C and D medical devices that are not included in the list of registrable medical devices based on FC No. 2020-001 – A shall be accepted until 31 March 2023; receiving of application for CMDN for these medical devices shall cease starting 1 April 2023; and all manufacturers, traders, exporters, importers, and distributors of the said medical devices shall secure a Certificate of Medical Device Registration (CMDR) starting 1 April 2023. On 21 April 2022, FC No. 2021-002-B was issued to extend the date wherein all Class B, C and D medical devices that are not included in the list of registrable medical devices based on FC No. 2020-001-A. In consideration of the challenges brought about by the full implementation of Administrative Order No. 2018-0002, the FDA recognizes that there is a need to provide medical device companies more time to prepare the technical documentary requirements based on the ASEAN common submission dossier template (CSDT) in applying for CM DR. 

SINGAPORE

Consultation on GN-20 Guidance on Clinical Evaluation

The Medical Devices Cluster (MDC) has released a draft of GN-20 Guidance on Clinical Evaluation for stakeholders’ consultation. The updates present HSA’s position on the use of real-world data in medical device clinical evidence and also some specific clarifications on clinical evaluation for software medical devices. We have also aligned the contents with IMDRF guidance on clinical evaluation, where applicable.

These ensure that the guidance reflects the latest thinking on essential topics relating to clinical evaluation. We would like to invite our stakeholders to provide feedback on the updates to GN- 20 Guidance on Clinical Evaluation.

The Consultation period for this document is from 27 October 2023 to 30 November 2023. Please email your feedback using the prescribed feedback form to [email protected] by 30 November 2023 and with “Feedback on GN-20” in the email subject header.

Gl-06-r2 medical devices product classification guide

The Health Sciences Authority (HSA) Has released the revised guidance document namely medical device product classification guide. The purpose is to aid with classification of some of the most challenging products.

For a medical device, the primary mode of action by which the intended purpose is typically achieved is by physical means (including mechanical action, replacement of, or support of the anatomy or of a physiological process).

GN-16-R4 Guidance on Essential Principles for Safety and Performance of Medical Devices Revision 4

For medical device to be supplied in Singapore, it must conform to the Essential Principles of safety and performance for medical device. Medical device dealers in Singapore are responsible to ensure that the relevant Essential principles of safety and performance are met, making reference to internationally recognized standards or equivalent. The document provided an overview on meeting the essential principles of safety and performance of medical device. All medical devices supplied in Singapore, regardless of whether the respective medical device require registration or has an exception from product registration requirements, are require to conform to the essential principles for safety and performance. 

GN-05-R3 Guidance on the Reporting of Adverse Events Revision 3

The Authority uses a number of post marketing risk assessment measures to ensure the continued safe use of medical devices. These measures include reporting from healthcare professionals, consumers or patients, mandatory reporting from medical device dealers and exchange of regulatory information with other medical device regulatory agencies. The document is applicable to all persons who register, manufacture, import and supply medical devices in Singapore. Persons who register, manufacture, import and supply medical devices in Singapore shall also be referred to as dealers of medical devices in the document.

GN-07-R3 Guidance on Complaint Handling Revision 3

An effective compliant handling system is an important part of any quality system. Any compliant received on a medical device should be evaluated and if necessary thoroughly investigated and analysed and corrective actions should be taken. The document is applicable to all persons who register, manufacture, import and supply by wholesale medical devices in Singapore. Complaints cornering death and serious injuries should be reported to the authority in accordance to mandatory reporting timelines stipulated in medical devices Regulation 2010. 

GN-33 R2 Guidance on the Application of Singapore Standard Good Distribution Practice for Medical Devices Revision 4

The company should develop a quality management system that conforms to the requirements of SS GDPMDS and demonstrate its ability to maintain the quality and integrity of medical devices throughout the supply chain. SS GDPMDS is applicable to importers wholesalers and outsourced service providers dealing with medical devices in Singapore. The guidance illustrates some approaches which an organization may follow in order to implement and maintain a quality management system that conforms to the requirements of SS GDPMDS. 

Consultation on GN-14 Guidance on the Risk Classification of In Vitro Diagnostic Medical Devices

This guidance is applicable to IVD device products that fall within the definition of an IVD medical device as defined in First Schedule of the Health Products Act (Act). This document provides guidance to assist product owners in risk classification 36 of in vitro diagnostic (IVD) medical devices using the appropriate risk 37 classification rules Regulatory controls should be proportional to the level of risk associated with an in vitro diagnostic (IVD) medical device. The level of regulatory control should increase with increasing degree of risk, taking account of the benefits offered by use of the IVD medical device. Therefore, there is a need to classify IVD medical devices based on their risks to patients, users and other persons. The risk presented by a particular IVD medical device depends substantially on its intended purpose and the effectiveness of the risk management techniques applied during design, manufacture and use. The risk presented by an IVD medical device also depends, in part, on its intended user(s), its mode of operation, and/or technologies. 

HSA Updates on Recent US FDA Announcements about Certain COVID-19 Antigen Rapid Self-Test Kits

The Health Sciences Authority (HSA) has received several enquiries on the recent antigen rapid self-test kit announcements by the United States Food and Drug Administration (US FDA). In Singapore, only COVID-19 antigen rapid self-test kits that have been authorised by HSA under the Pandemic Special Access Route (PSAR) or full registration can be supplied. HSA has evaluated these test kits to meet the required safety, quality and efficacy standards before granting PSAR authorisation or full registration. 

GL-08: Regulatory Guidelines for Laboratory Developed Tests (LDTs)

This document provides guidance and clarity in assisting clinical laboratories on understanding the regulatory requirements applicable to Laboratory Developed Tests (LDTs) under the Health Products Act 2007 (HPA) and Health Products (Medical Devices) Regulations 2010 (HP (MD) Regulations). LDTs are in vitro diagnostics (IVD) that fall within the scope of the definition of medical devices stipulated under the first schedule of the HPA. This guideline is applicable to all LDTs (i.e. products including test reagents, and kits) developed within a licensed clinical laboratory solely for use within the same laboratory. This does not include test reagents and kits developed within a licensed clinical laboratory and distributed outside of the laboratory where it was developed as these will be regulated as commercial IVD products by HSA.

TAIWAN

Announcement of 112 Annual Medical Device Standards Acceptance List” and “Repealed Previously Accepted Medical Device Standards List

In order to promote the international harmonization of medical device laws and regulations, and assist the industry to follow and refer to them when developing and manufacturing medical devices, the Department continues to promote the approval of medical devices. From 1993 to 110, 11 announcements have been made. Currently A total of 1,081 domestic and foreign medical device standards have been adopted to provide the industry as a reference for R&D and manufacturing of medical devices. This announcement ” 112 Annual Medical Device Standards Acceptance List” (Appendix 1), a total of 1,156 medical device standards were adopted, including 76 new items, 1 abolished item and 1,079 original approved standards (of which 61 items The standard has been updated). For the medical device standards adopted in previous announcements, if the original standard version has been abolished, a total of 255 items in the “List of Originally Accepted Medical Device Standards Repealed Over the Years” (Appendix 2) are sorted out. Please adopt the new version or relevant replacement standards as soon as possible. This case is also published in the announcement area and the special area of medical device regulations of the FDA’s global information website (www.fda.gov.tw)

Announcement the establishment of the “Guidelines for the Evaluation of Gender Differences in Clinical Trials of Medical Devices” (Published on 02 March, 2023)

Announcement is established for the benefit of medical device manufacturers and research institutions, in the process of R&D, marketing and management of medical device products, it is appropriate to include gender differences in the recruitment of subjects, research design, statistical analysis, data interpretation and disclosure of research results in clinical trials. The content, etc. shall be considered, and supplemented as the basis or supporting information for the efficacy or safety of medical devices, and the announcement shall formulate the guidelines. This case is also published in the announcement area and the medical device clinical trial area of the FDA’s global information. 

Announcement to amend the “Standards of Administrative Fees for Medical Devices” (Published on 23 February, 2023)

Amend the “Standards of Administrative Fees for Medical Devices”. With the revised “medical equipment administrative fee charging standard” The fees payable for each of the following medical device application cases are as follows: 

ROW

ARGENTINA

ANMAT and ANVISA signed the first Mutual Recognition agreement on certificates for Medical Products

This agreement between the regulatory agencies of Argentina and Brazil strengthens confidence in decisions to protect the health of the population and will imply greater agility in processing for this category of products.

It is specifically an “Agreement for Mutual Recognition of Free Sale Certificates and Certificates for Foreign Countries for Medical Devices Risk Classes I and II and Medical Devices for In Vitro Diagnostics of Risk Classes A and B”, which implies the strengthening of trust in the decisions of the Agencies and recognition of the efforts that each one makes to protect the health of the population. At the same time, it will optimize regulatory processes in both agencies.

AUSTRALIA

Quality management system audits and certification guidance

This guidance provides information for medical devices manufacturers on how we conduct Quality Management System (QMS) audits, roles and responsibilities for audits, aspects of conformity assessment certification relating to auditing and post-audit activities.

A manufacturer generally must implement a quality management system (QMS) based on recognised standards and the regulatory requirements and have the QMS assessed by us or a recognised conformity assessment body.

How to submit a custom-made medical device and patient-matched medical device notification

This guide will assist you with completing and submitting a Custom-Made Medical Device (CMMD) notification and Patient-Matched Medical Device (PMMD) transition notification.

The following guide is designed to assist you with completing and submitting a:

Both notifications can be submitted using the CMMD notification form.

Refinements to the Personalised Medical Device Framework

Guidance to assist sponsors and manufacturers comply with new regulations. In July 2021, we undertook a public consultation on proposed refinements to the personalised medical devices framework.

The following refinements have now been agreed:

Personalised medical devices (including 3D-printed devices)

The document provides information and examples to help you understand the Framework and meet your regulatory obligations.

The intention of the examples is not to tell you how every device is regulated, but to provide enough information to help you identify the concepts and boundaries in the Framework so you can apply these concepts to your own circumstances.

GMP clearance application and submission user guide

It is step-by-step guide on submitting a GMP clearance application in TBS portal.

Applications for Good Manufacturing Practice (GMP) Clearance need to be submitted through the TGA Business services (TBS) portal. Before applying, you should understand your Sponsor responsibilities and familiarise yourself with the GMP requirements for the particular category of medicine you intend to supply to Australia.

GMP clearance guidance

This guidance is for sponsors seeking to obtain Good Manufacturing Practice (GMP) clearance for an overseas manufacturing site used in the manufacture of a medicine, or an Active Pharmaceutical Ingredient (API) used in a medicine, intended for supply in Australia.

This guidance is not intended for sponsors of:

Clinical evidence guidelines 

The guidelines provide details and guidance on the clinical evidence requirements for medical devices, including in vitro diagnostic medical devices (IVDs), under Australian legislation. For IVDs, there is also a supplementary document titled ‘Clinical evidence guidelines supplement: In vitro diagnostic (IVD) medical devices’, which should be reviewed in conjunction with these guidelines. The guideline are intended to be a common reference point for both industry and the regulator – assisting sponsors and manufacturers to collect, compile and present clinical evidence in a manner that meets regulatory requirements, while reflecting our approach to how it assesses clinical evidence.

Although it is recognised that other approving regulatory bodies might be comparable, the evaluation strategies of manufacturers intending to market a medical device in Australia should be consistent with the guidelines.

The ARGMD (Australian Regulatory Guidelines for Medical Devices) provides information on the import, export and supply of medical devices within Australia 

The ARGMD provides information regarding Frequently requested information, Essential Principles. Conformity assessment, Medical device inclusion, Post market on the import, export and supply of medical devices within Australia.

Guidance on the format requirements for dossiers: General dossier requirements 

General dossier requirements give assistance for an applicant, to meet requirements for the dossier of information which send to the authorities for an evaluation in support of the following types of applications:

To vary the ARTG record which requires supporting information.

Regulation of software based medical devices 

The purpose of this guidance is to help manufacturers and sponsors understand how the TGA interprets requirements, and thus indicate how manufacturers and sponsors can comply.

This is a guide only, and manufacturers and sponsors are encouraged to familiarize themselves with the legislative and regulatory requirements in Australia, and if necessary, to seek professional advice. It is the responsibility of each manufacturer or sponsor to understand and comply with these requirements.

Reclassification of spinal implantable medical devices

The purpose of this guidance is to assist sponsors and manufacturers of spinal implantable medical devices to understand and comply with new regulatory requirements.

From 25 November 2021, some spinal implantable medical devices will be required to be reclassified. The new regulatory requirements will also include:

The classification of spinal implantable medical device will determine the safety and performance requirements to be demonstrated to meet regulatory requirements. 

Reclassification of active medical devices for therapy with a diagnostic function

This guidance aims to assist sponsors of active medical devices for therapy with a diagnostic function with meeting their obligations and outlines transitional arrangements to help comply with new regulations. From 25 November 2021 active medical devices for therapy with a diagnostic function will be required to meet regulatory requirements demonstrating the safety and performance for Class III medical devices.

Requirements for reclassification

The requirements include:

Reclassification of medical devices in direct contact with the heart, central circulatory and central nervous systems 

This guidance aims to assist sponsors of medical devices intended to be used in direct contact with the heart, central circulatory system (CCS) or the central nervous system (CNS) with meeting their obligations and outlines transitional arrangements to help comply with new regulations.

From 25 November 2021 medical devices intended to be used in direct contact with the heart, central circulatory system (CCS) or the central nervous system (CNS)will be required to meet regulatory requirements demonstrating the safety and performance for Class III medical devices.

Reclassification of medical devices that administer medicines or biologicals by inhalation 

This guidance aims to assist sponsors of medical devices that administer medicines or biologicals by inhalation with meeting their obligations and outlines transitional arrangements to help comply with new regulations.

From 25 November 2021 medical devices that administer medicines or biologicals by inhalation will be required to meet regulatory requirements demonstrating the safety and efficacy of the product commensurate with the higher classification (Class IIa or Class IIb). 

Varying entries in the ARTG Medical devices and IVD medical devices

The guidance is for sponsors applying for a variation to the Australian Register of Therapeutic Goods (ARTG) entry of a medical device or IVD medical device.

It is important that the information included in the ARTG is kept up-to-date and is correct from a public health, regulatory and transparency point of view. When any information included in the ARTG has changed, the sponsor should consider if they need to request the TGA to vary the respective ARTG entry.

If you want to correct an ARTG entry that is incomplete or incorrect, you will need to apply to the TGA under subsection 9D (1) of the Therapeutic Goods Act 1989 by submitting either a Variation to Class III/AIMD, IVD Variation or Device Change Request (DCR) application.

Changes that may require variation of an ARTG entry:

Sponsor wants to vary the list of IVD devices included in the ARTG entry There is no legislated timeframe for the evaluation of an application to vary an ARTG 

Deadline for certain medical device reforms to be extended

The Government recently agreed to extend the deadlines for several medical device reforms underway in Australia, because of the impact of the European Union Medical Device Regulations (EU MDR) transition.

Regulatory amendments are underway and are expected to be in place this year. The extended deadlines would give manufacturers time to obtain an EU MDR certificate before the end of the EU MDR transition on 31 December 2028, and for sponsors to use the MDR certificate to apply to the TGA before 1 July 2029.

Transition to new manufacturer evidence for IVD medical devices – Guidance for manufacturers and sponsors of IVD medical devices 

This guidance is to help sponsors and manufacturers of in vitro diagnostic (IVD) medical devices transition to new manufacturer evidence requirements.

Sponsors who need to transition to new manufacturer evidence will need to act to ensure ongoing regulatory compliance. The extent of those actions will depend on a range of factors and this guidance covers a range of scenarios and examples to help identify the correct pathways and sponsor actions.

Medical device patient information leaflets and implant cards

This guidance provides an overview of the different types of patient information materials (patient information leaflets and patient implant cards); when patient information must be supplied; how to meet the mandatory requirements for patient information; and best practice requirements for patient information.

Guidance on applying the Advertising Code 

This guidance provides for when the Code applies to advertising, and that advertising must meet requirements including briefly that it is accurate, balanced, not misleading, is substantiated, and encourages the safe and proper use of therapeutic goods.

Reclassification of active implantable medical devices (AIMD) 

This guidance aims to assist sponsors of active implantable medical devices (AIMD) with meeting their obligations and outlines transitional arrangements to help comply with new regulations. From 25 November 2021 active implantable medical devices will be required to be reclassified from Class AIMD to Class III.

The proposed regulatory changes supported the commitment made in the Australian Government Response to the Review of Medicines and Medical Devices Regulation to align Australian medical device regulations, where possible and appropriate, with the European Union framework. Stakeholders who responded to the public consultation were broadly supportive of aligning the Australian medical devices framework with the EU framework; however, there were diverse views regarding the proposal to reclassify accessories to active implantable medical devices.

Essential principles checklist (medical devices) 

TGS has updated the Essential principles checklist, Refer Medical Devices Essential Principles checklist on below link

Reclassification of medical devices that are substances to be introduced into the body or applied to and absorbed by the skin

The guidance aims to assist sponsors of medical devices that are substances for introduction into the body with meeting their obligations and outlines transitional arrangements to help comply with new regulations. The guidance is specific to medical devices that are composed of substances or of combinations of substances that are intended to be introduced into the body via a body orifice or applied to and absorbed by the skin.

Consultation: TGA Fees and Charges Proposal 2023-24

About this consultation

To meet its responsibilities, the Therapeutic Goods Administration (TGA) recovers costs from industry in accordance with Australian Government cost recovery arrangements. The TGA is conducting a public consultation to provide industry and other interested stakeholders with an opportunity to comment on the TGA’s proposed fees and charges for the 2023-24 financial year. Specifically, we are seeking feedback on the potential impact/s of the proposed changes, prior to seeking approval from the Government for any changes.

Specifically, the government provided AU$23.3 million ($16.1 million) to complete TGA’s digital and business transformation and enable full implementation of the unique device identifier system and is paying the regulator’s landlord AU$4.85 million annually for 15 years to cover the fit out of its laboratory. Industry will ultimately pay for the work. After factoring in cost recovery and lease charge back, TGA has calculated that annual charges for medicines and medical devices will increase by 11.56% and 12.33%, respectively. The increase for other annual charges, such as manufacturing licenses, is 11.1%.

Essential Principles – consent for non-compliance 

This guidance document provides information about

BAHRAIN

Circular no (15) 2023 To All medical device importers and Healthcare facilities

Medical Device Incidents Reporting Pursuant to Decision (48), On Medical Devices and Products’ Quality Control, Article (11) which states that “The Authority reviews and checks the alerts received by its Medical Devices and Products reporting Center and takes the necessary measures to ensure the safety of public health, and when needed, issues field safety notices to educate users of the medical device and product to the relevant patients, and also review the text and content of the alerts with the medical device and product manufacturer or authorized representative before issuing the alert, and in light of NHRA role in regulating and monitoring the safety of medical devices during the post market phase, NHRA urges healthcare facilities to report medical devices incidents directly to NHRA or to the authorized representative or the distributor where the device has been bought from in order to take the necessary actions and to ensure the safety of patients and end user. 

Circular no (14) 2023 To All Medical Devices Importers

The National Health Regulatory Authority would like to alert all Medical Devices importers that HS Code 38221900(009) is now regulated under the Medical Devices Regulations department. However, in order to ensure all required documents are available with the importer, grace period will be granted where applicants can obtain an approval for the shipment by only attaching the invoice, while fulfilling the Fees calculation procedure explained in the Importation Guideline available on NHRA website. Please note that the grace period mentioned above is two weeks from the date of this circular.

Circular No. (02) 2023: To All Medical Devices Importers- Authorized Representatives Scope verification with the Imported Shipments

The National Health Regulatory Authority would like to announce the initiation of scope verification for authorized representatives with the scope of importation shipments as part of the importation applications review process. As a result, any importation shipment that is not within the authorized representative’s registered scope will not be approved. Importers can contact Medical Device Regulations department via [email protected] email for any inquiries. Authorized representatives who intend to add or modify the scope registered in their license can apply online through AJHEZA system. 

BRAZIL

ANVISA updates rules on clinical investigations with medical devices

ANVISA published, on 12/15, Collegiate Board Resolution (RDC) 837/2023, which updates the rules on clinical investigations with medical devices. The standard comes into force on January 4, 2024 and aligns the Brazilian regulatory scenario with international practices, in addition to establishing, more clearly, the clinical investigations subject to submission to the Agency. 

The new RDC eliminates the need to submit the Consent process in the Clinical Research Process, which was mandatory for each clinical investigation under the Medical Devices Clinical Investigation Dossier (DICD) regime. The submission of all documentation, relating to the medical device and the clinical investigation plan, will be carried out under a single DICD process, making analysis faster. Regarding the delimitation for ANVISA’s consent, as of the effective date of the new standard, that is, January 4th, only clinical investigations whose results may support the registration of class III medical devices will be subject to submission to the Agency. and IV in Brazil. The standard therefore eliminates the need to submit notifications for post-marketing studies and class I and II medical devices for prior approval by ANVISA.

ANVISA updates rules on medical devices for in vitro diagnosis

The health framework is made according to the risk that the use of the IVD device ecificns. missible or to evaluate immunological compatibility in cell administration procedurestra testsagen detection at products aimed to IVD instruments that do not use reagents, for sesp risk classification rules The new RDC provides of the user. the represents public health and

The standard also has classification rules aimed at companion diagnostics (complementary diagnosis. Furthermore, controls without assigned values are now considered medical devices for diagnosis neonatal gematrito products aimed at and product corresponding biological) of a medicine or safe and effective use.

ANVISA and ANMAT sign agreement on easing regulatory requirements for low-risk medical devices

ANVISA and the National Administration of Medicines, Food and Medical Technologies (ANMAT) signed the “Agreement on Mutual Recognition of Free Sale Certificates and Certificates for Foreign Country for Medical Devices of Risk Classes I and II and Medical Devices for In Vitro Diagnosis of Risk Classes A and B”.

The agreement represents an advance in cooperation and convergence between regulatory authorities in Brazil and Argentina, in addition to providing opportunities for increased bilateral trade in lower-risk medical devices, by simplifying procedures with health authorities.

The Brazil Regulatory Authority(ANVISA)published new topics for SaMD software regularization

With the publication of Collegiate Board Resolution (RDC) 657/2022, ANVISA established the requirements for the regularization of software as a medical device (SaMD, Software as a Medical Device) and made the following matters available via petition:

ISRAEL

Administrative extension of validity for registration certificates in the medical equipment register

In view of the war situation and following the regulatory changes and validity extensions given in Europe to regulatory approvals, the Ministry of Health has been prepared to ensure a regular supply of medical equipment in Israel. Therefore, we would like to clarify that the automatic administrative extension of validity given on March 29, 2023 for AMR approvals (registration approvals in the medical equipment register) will be extended for an additional period of time, according to the following details:

The Ministry of Health publishes the outline of the implementation of the reform in the medical equipment

The Medical Equipment Reform (MED) is a significant and wide-ranging move, the goal of which is to reduce the bureaucratic burden and create enabling regulation. This reform joins other reforms made in the Ministry of Health over the past year. The outline will lead to a significant reduction in the registration and importation times of medical equipment in Israel and will ease the regulatory burden on the practitioners in the field and on the hospitals, the funds and the doctors who use this equipment.

The AMR reform will facilitate the import of medical equipment, and will help increase the supply for consumers and lower costs. This is another step in the fight against the cost of living, which will allow the health system to become more efficient and provide a broader response to citizens. The Ministry of Health will continue to work to reduce regulation in every area where it is possible to do so, responsibly and while maintaining and adhering to control and quality assurance for the sake of public health. 

Ministry of Health: An administrative extension of validity will be granted to AMR approvals – medical equipment

An automatic extension of validity will be given to AMR approvals for:

Medical equipment registered in the register of medical accessories and devices maintained by the Ministry of Health and the validity of the AMR approval has expired between 12.1.2022 and 4.30.2024. 

Medical equipment for which registration renewal approval was granted, the expiration date of which is between December 1, 2022 and April 30, 2024. 

The new validity of these permits will be until May 31, 2024, without the need to apply to the Ministry of Health, unless the permit has been canceled, or a decision has been made to refuse to renew it. The extension of the validity of the certificates is automatic and there is no need to contact the Ministry of Health in order to extend the registration. 

This extension of validity does not apply if there is a change in the medical equipment that requires a submission to change the registration in accordance with the current guidelines, or if the Ministry of Health has ordered the cancellation of the registration of the medical equipment in the register or its suspension. 

MEXICO

COFEPRIS transparent requirements card for authorization of medicines and medical devicesResolution No.001 – Regulation of Medical Devices Provision

The Federal Commission for the Protection against Sanitary Risks (COFEPRIS) presents the guides for the application for the sanitary registration of medical devices, and for entering the information for the application for sanitary registration of medicines, in line with the regulatory certainty strategy. The guide for medical devices contains the essential requirements, as well as the scientific, technical and legal information that they must comply with, which are classified as I, II and III, depending on their risk level; In addition, medical software (ScDM) is included to demonstrate its safety and effectiveness. Likewise, it seeks to facilitate the way of including information in the corresponding dossier, thus simplifying the process for applicants.

COFEPRIS is promotes new Regulatory Certainty Strategy for medical devices

The main objective of the strategy is to strengthen capacities in the regulation of these fundamental inputs for public health.

The Regulatory Certainty Strategy proposal aims to establish a work agenda that covers the period 2023-2026 and that includes a comprehensive vision aligned with the highest international standards. In addition, it includes five commitments that will be implemented over a period of four years, along with high-impact measures to build a fair, agile and transparent regulatory environment.

Mexico accepts other countries’ GMPs to facilitate import of biologics; claims doubling of device approvals

Citing the need to improve access to vital medicines, COFEPRIS is allowing foreign makers of biologics sold in Mexico to forego obtaining a Certificate of Good Manufacturing Practices (GMP) from the agency before their products can be released in the country. Instead, as of 23 August, they may present GMPs issued by other health authorities accredited by the World Health Organization (WHO), PAHO, or members of the Pharmaceutical Inspections Cooperation Scheme (PIC/S) in lieu of a COFEPRIS certificate. The new rule is intended to complement ongoing efforts by COFEPRIS, announced earlier this month, to promote local manufacturing of biologic and biosimilar products, according to a statement from the agency. Together, “these actions are an important step to ensure that Mexicans have access to safe, effective, and high-quality biotechnological and biosimilar medicines, and reinforce the health authority’s commitment to the health of the entire population,” the statement said. Days earlier, in a separate announcement, the agency said it had authorized 1,588 new medical devices in 2023, representing an increase of some 125% from 2022 and an 88% approval rate.

In 2023, COFEPRIS doubles authorizations for new medical devices

Mexico City, August 20, 2023.- The Federal Commission for the Protection against Sanitary Risks (COFEPRIS) carries out robust and specific efforts to expedite the attention to authorizations and procedures regarding medical devices, which are beneficial of the health and quality of life of the population. So far in 2023, 3,285 health registration procedures have been attended, of which 1,588 new medical devices have been authorized, that is, 125 percent more authorizations than the same period in 2022; Two thousand 937 procedures for modifications to the health registration conditions and more than three thousand 450 extension procedures have been attended, so it is projected that the attention to procedures will more than double by the end of the year. It is important to note that 88 percent of the procedures handled have been approved. 

PANAMA

Resolution No.001 – Regulation of Medical Devices Provision

The Ministry of Health – Republic of Panama has released guidelines for the storage and distribution of medical devices and related products and adopts the Form called Good Practices for Storage and Distribution of Medical Devices and Related Products. All applications for operating license procedures for manufacturing, conditioning, distribution, and warehouse establishments must contain documentation of the Compliance with the Guidelines for the storage and distribution of MEDICAL DEVICES and end products, as a requirement for their evaluation. The details regarding the storage and distribution practices of medical devices and related products are defined in the document. 

SAUDI ARABIA

Guidance on Medical Devices Samples Collection (MDS-G013)

The purpose of this document is to clarify the procedures of medical devices samples collection for laboratory testing in order to ensure their quality, safety, and effectiveness, and their conformity with the standards approved by the SFDA

This document applies to:

Clinical Studies Requirements for Medical Devices and Supplies (MDS-REQ 2)

The purpose of this document is to define and clarify the requirements for conducting clinical studies of medical devices and supplies in the Kingdom.

This document applies to clinical study verification facilities (CRO-Organization Research Contract) and other entities that wish to conduct clinical studies for medical devices and supplies or performance evaluation studies for laboratory and diagnostic devices in the Kingdom.

For the purposes of this document, “clinical study/s” is synonymous with “performance evaluation study/s” and “clinical trials.”

Guidance on Saudi Food and Drug Authority Policy for Engagement with Healthcare Practitioners

SFDA policies for engagement with healthcare practitioners across the KSA are designed to serve all review branches of SFDA, including medical devices and drugs. Oversight for the HCP Engagement Program will be housed in the SFDA. HCP engagement policy will cover several programs. These programs will include the following:

These programs will provide different avenues by which SFDA and HCPs engage and exchange information. Each program will have a process by which engagement activities occur, criteria for participation, and expectations for outcomes of the activity.

Guidance on Manufacturing Paths of Medical Devices

SFDA (Saudi Food & Drug Authority) has issued guidance document on Manufacturing Paths of Medical Devices includes requirements of manufacturing Circulation and Distribution, Manufacturing Paths, Free Sale Certificate, Importing for the Purpose of Local Manufacturing.

The purpose is to clarify paths of manufacturing medical devices locally (including the transfer of its technology and its settlement in the KSA), its circulation, distribution within the KSA and exportation, in addition to guide manufacturers to the SFDA requirements published on its website.

The Saudi Health Authority (SFDA)has released Guidance on Requirements for Quality Assurance Programs for Radiation Emitting and Imaging Devices (MDS-G15)

Radiation emitting and imaging devices are one of the most effective methods for examining and diagnosing different health conditions. Since radiation emitting and imaging devices depend entirely on the X-rays production, there are potential health risks associated with using such devices. In order to maintain a high-quality image and keep the radiation dose to the minimum, healthcare providers are required to obligate to national and international requirements for quality assurance programs for radiation emitting and imaging devices. The purpose of this Guidance is to specify and clarify the requirements for quality assurance programs for radiation emitting and imaging devices including mammography. The Guidance applies to all for radiation emitting and imaging devices including mammography used inside healthcare facilities located in KSA.

MDS-REQ 3 – Requirements for Safe Use of Medical Devices Inside Healthcare Facilities

The purpose of this document is to specify and clarify the requirements for safe use of medical devices and radioactive medical materials inside healthcare facilities in order to ensure safety, efficiency and quality of them, and reduce potential risks corresponding to use and handle them inside healthcare facilities. 

MDS-REQ 6 – Requirements of Importation and Re-Exportation for Radioactive Materials Used in Medical Applications

The purpose of this document is to specify and clarify the requirements for importing and re exporting radioactive materials used in medical applications. This document applies to: 

Requirements on Importation and Shipments of Medical Devices

The purpose of this document is to define and clarify the import and clearance requirements for medical devices and supplies. This document applies to medical devices and supplies and their accessories to be imported. 

MDS – G012 Guidance on MDMA – Significant and Non-Significant Changes

The purpose of the document is to clarify the requirements, with examples, of reporting or notifying the SFDA of significant and non-significant changes to marketing authorized medical devices/supplies, referred to in “Executive Regulation of Law of Medical Devices”/article (10-8), and “Requirements for Medical Devices Marketing Authorization (MDS-REQ1)”/Section (5). 

Guidelines for manufacturing paths for medical devices and supplies (MDS-G011)The purpose of the guide is to clarify the paths of manufacturing medical devices and supplies in the Kingdom), trading, distributing and exporting them in the Kingdom, in addition to directing manufacturers to the requirements of the Authority published on its website. This guide applies to local factories for medical devices and supplies. 

Transport and Storage Requirements for Medical Devices and Supplies (MDS-REQ 12)

The purpose of the document is to define and clarify transportation and storage requirements for medical devices and supplies. This document applies to the Factories inside the Kingdom. Importers and distributors Warehouses of medical devices and supplies. Providers of medical maintenance services. 

Post-marketing control requirements for medical devices and supplies (MDS-REQ11)

The purpose of this document is to define and clarify post-marketing control requirements for medical devices and supplies, which includes the procedures and activities described in the section “Scope of application” below. 

National Diagnostic Reference Levels

The purpose is to introduce the national references in order to identify and establish the National Diagnostic Reference Levels (NDRLs) for different diagnostic ionizing radiation applications, as well as to clarify the SFDA’s requirements in applying these references. These references protect patients from medical radiation doses that may exceed the approved limits and levels, which may be unjustified, without affecting the image’s quality and its diagnostic characteristics. 

This national reference is applied to radiology department that have the following imaging modalities: 

MDS – G009 – Guidance for Points of Care (POC) Medical Devices Manufacturing

This Guidance applies to healthcare providers wishing to manufacture medical devices within their facilities for their own use and for non-industrial scale (with regard to the magnitude and methods of production). This Guidance document applies to the following activities:

MDS – G010 – Guidance on Artificial Intelligence (AI) and Machine Learning (ML) technologies based Medical Devices

The purpose of this guidance is to clarify the requirements for obtaining Medical Devices Marketing Authorization (MDMA) for Artificial Intelligence (AI) and Machine Learning (ML) based medical devices, in order to place them on the market within KSA. This guidance applies to Artificial Intelligence (AI) and Machine Learning (ML) technologies that diagnose, manage or predict diseases by analyzing medical data.