Medical Devices-Asia and ROW Regulatory News-June 2023

ASIA

INDIA (CDSCO)

Amendment to Rule 18 and 19 for State Medical Devices Testing Laboratories 

The Government of India has amended Rules 18 and 19 (G.S.R. 409(E)) to allow states to establish or designate State Medical Devices Testing Laboratories (MDTLs) for device testing and evaluation. Only laboratories accredited by NABL may be designated as MDTLs.

National Medical Devices Policy, 2023 

India has introduced a national policy aimed at improving medical device regulations, reducing duplication in licensing, and minimizing unnecessary compliance burdens. The policy highlights the sector’s importance to the national healthcare system and outlines classifications across electronic equipment, implants, disposables, surgical instruments, and IVDs.

CHINA (NMPA)

Release of Four Guidelines for Medical Device Registration Review 

The Center for Device Evaluation (CDE) has issued guidelines covering: 

• • Needle-free injector systems 
• • Single-use arterial blood sample collectors 
• • Percutaneous enteral nutrition catheters 
• • Updated quality management requirements for device operations 

These documents establish testing, performance, and quality expectations for Class III passive devices.

Draft Revision of Medical Device Operation Quality Management Standards 

NMPA is seeking comments on revised quality management requirements for medical device operations, covering procurement, storage, sales, transportation, and after-sales activities.

Guiding Principles for On-Site Inspection of Specialized Storage/Transport Enterprises 

New on-site inspection guidelines define expectations for enterprises specializing in device storage and transportation, including inspection checklists and compliance responsibilities.

Guideline on Recombinant Collagen Wound Dressings 

NMPA has released guidance for Class II recombinant collagen wound dressings used for non-chronic wound care. Requirements include characterization of recombinant humanized collagen and guidance based on biotechnology evaluation principles.

Calls for Participation in Guideline Development 

NMPA is inviting domestic and international organizations to participate in developing and revising several registration review guidelines, including those related to indwelling cannulae, hydrogel dressings, absorbable sutures, anti‑adhesion products, hemostatic products, medical adhesives, hemodialysis tubing, and hydrocephalus shunts.

Notice on Public Comments for Seven IVD Guiding Principles 

Manufacturers with relevant experience are invited to provide input on updated IVD review guidelines, including estrogen and progesterone receptor antibody reagents.

PAKISTAN (DRAP)

Maximum Retail Pricing for Cardiac Stents 

DRAP has notified updated maximum retail prices for cardiac stents, approved by the Federal Government under the Drug Regulatory Authority Act.

SINGAPORE (HSA)

HSA Recognized as WHO Stringent Regulatory Authority (SRA) for High‑Risk IVDs 

HSA’s recognition as an SRA allows Class C and D IVDs registered in Singapore to benefit from expedited WHO prequalification. This strengthens international confidence in HSA’s regulatory processes.

Consultation on GN‑14—Risk Classification of IVD Devices 

HSA has released updated guidance on classifying IVD devices based on their risk level, intended use, user type, and technological characteristics.

MALAYSIA (MDA)

Guidance on Medical Face Masks and Respirators (Third Edition) 

The updated guideline clarifies requirements for medical-grade face masks and respirators under Act 737 and highlights WHO classifications of procedure and surgical masks.

Market Surveillance of Unregistered Devices 

MDA continues to enforce market surveillance to ensure only registered and licensed devices are used. Recent inspections identified unregistered electro‑stimulation devices used in health centers.

Transition to Electronic Medical Device Registration Certificates 

From 2 May 2023, electronic certificates may be downloaded via MeDC@St2.0+. Physical certificates will be phased out by 31 December 2023.

KAZAKHSTAN (NDDA)

Updated Rules for Market Selection of Medicines and Devices 

Amendments remove deadlines for contracting processes and introduce clarifications on timelines for expert reviews and sampling schedules.

HONG KONG (MDD)

New Procurement Strategy for Medical Devices 

The Department of Health will prioritize devices listed under MDACS when procuring equipment, improving quality assurance and safety monitoring. Suppliers are encouraged to register their devices under MDACS.

ROW

TURKEY (TMMDA)

Product Tracking System (ÜTS) Requirements 

Companies registering as Manufacturer/Importer/Dealer/Exporter must possess a medical device sales center license and provide a valid ÇKYS number. Records lacking this information will be deactivated.

Guidance on Consultation Procedures in Medical Device Regulation 

New guidance outlines the classification of combination products and the procedures for obtaining scientific opinions from notified bodies.

BAHRAIN (NHRA)

Medical Device Incident Reporting 

NHRA urges healthcare facilities to report device-related incidents directly to regulators or authorized representatives to support post-market safety monitoring.

Regulation of HS Code 38221900 (009) 

A grace period is provided for importers to comply with new documentation requirements for regulated products under this HS code.

SAUDI ARABIA (SFDA)

Requirements for Importation and Clearance of Medical Devices 

SFDA has published updated guidance defining importation requirements for devices and supplies, including documentation and compliance obligations.

AUSTRALIA (TGA)

Patient Information Leaflets and Implant Cards 

Updated TGA guidance describes mandatory and recommended content for patient information materials supplied with implantable and high‑risk devices.

Advertising Code Guidance 

This guidance clarifies when the Advertising Code applies and outlines requirements that advertising be accurate, evidence‑based and not misleading.

FAQs on Personalized Medical Devices 

TGA has provided updated FAQs to support compliance with regulatory requirements for custom-made and 3D‑printed medical devices.

Reclassification of Active Implantable Medical Devices 

AIMDs are now reclassified from “AIMD” to Class III as part of Australia’s alignment with EU regulatory frameworks. Transitional arrangements and stakeholder feedback have been considered in implementing the new classification rules.