Medical Devices – USA, Europe, Asia and ROW Regulatory News – May 2025

USA

Guidance Document: Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program

The aim of this guidance document is to outline the various mechanisms available to submitters for requesting interactions with the Food and Drug Administration (FDA) concerning medical device submissions. These interactions may encompass written feedback or meetings related to medical device Investigational Device Exemption (IDE) applications, Premarket Approval (PMA) applications, Humanitarian Device Exemption (HDE) applications, Evaluation of Automatic Class III Designations (De Novo requests), Premarket Notification (510(k)) submissions, Clinical Laboratory Improvement Amendments (CLIA) Waiver by Applications (CW), Dual 510(k) and CLIA Waiver by Application submissions (Duals), Accessory Classification Requests, as well as certain Investigational New Drug Applications (INDs) and Biologics License Applications (BLAs) submitted to the Center for Biologics Evaluation and Research (CBER) (specifically, INDs and BLAs for devices regulated as biological products under section 351 of the Public Health Service (PHS) Act).

EUROPE

EU rules on health technology assessment (Regulation 2021/2282)

The European Commission is consulting on joint clinical assessments of medical devices and in vitro diagnostics under the Health Technology Assessment Regulation (HTAR) until 25 June. Following last year’s HTAR regulations, the draft regulation establishes procedural rules for assessments, which will start only after a device receives its CE mark. The HTA secretariat will notify developers of selections and facilitate communication. The Commission aims to set deadlines for finalizing assessment scopes and reports, advising the JCA Subgroup to wait for device selection before finalizing scopes.

AUSTRALIA

Guidance Document: Regulatory requirements for in vitro diagnostic (IVD) companion diagnostics

This guidance provides a detailed overview of the regulatory framework for in vitro diagnostic companion diagnostics (IVD CDx) and the associated medicines or biological products that require CDx testing. It applies to both commercial IVD CDx devices and in-house tests developed by pathology laboratories, outlining clinical and analytical performance requirements to ensure these diagnostics are safe and effective. The framework covers device classification, approval processes, and the coordination between medicine and device sponsors, including requirements for clinical evaluation, companion testing plans, and post-approval monitoring. It emphasizes the need for clear instructions for use and product information to support proper clinical application. While it focuses on regulatory compliance, it does not interfere with healthcare practitioners’ clinical decisions and excludes clinical trial and reimbursement guidance. The regulatory authority plans ongoing monitoring and review of the framework to adapt to the evolving nature of CDx technologies.

BELGIUM

The FAMHP lists unavailable medical devices that risk patient safety

The FAMHP has created a section to publish information on medical devices and in vitro diagnostic medical devices that are temporarily or permanently unavailable in Belgium, as per Article 10bis of EU regulations 2017/745 (MDR) and 2017/746 (IVDR), introduced by regulation (EU) 2024/1860. This list addresses devices whose absence could pose serious risks to patient safety or public health. Updated regularly with data from manufacturers, the information is intended for healthcare professionals, patients, and supply chain actors to monitor market trends and assess the implications of device unavailability. Manufacturers bear the responsibility for providing accurate availability data.

BRAZIL

Anvisa Opens Public Consultation on UDI Database for Medical Devices.

Anvisa has initiated a targeted consultation to support the development of a new federal regulatory framework for medical devices. This consultation will focus on the classification and regularization of reusable and single-use devices, as well as good practices for their processing. The initiative is part of Anvisa’s strategic effort to modernize Brazil’s medical device regulations. The consultation officially launched on May 13, 2025, with a virtual event held via Microsoft Teams, and is exclusively directed at members of the National Health Surveillance System (SNVS). Contributions will be accepted from May 13 to June 13, 2025, and will form the basis for drafting four new regulatory standards. These drafts will later be submitted for public consultation, allowing broader societal participation. Anvisa will share the contribution forms during the launch event and on its official portal.

Anvisa Releases Preliminary Manual for UDI Database Implementation.

Anvisa has released a preliminary manual for the new Unique Device Identification (UDI) database, aligned with RDC 591/2021 and international IMDRF standards. The manual covers completed features of the system and prepares stakeholders for the upcoming launch, which depends on the approval of Public Consultation CP 1,313/2025. The UDI database aims to enhance medical device traceability and patient safety in Brazil. Compliance deadlines will be phased by risk class—Class IV: 3.5 years, Class III: 4 years, Class II: 5 years, and Class I: 6 years—from the normative instruction’s effective date. This initiative is a key priority in Anvisa’s 2024–2027 Strategic Plan.

FINLAND

New requirements for UDI marking of medical devices to come into effect in May 2025

The European Union will enforce new requirements mandating Unique Device Identification (UDI) markings for, all Class I medical devices and Class B and C in vitro diagnostic medical devices must display a Unique Device Identifier (UDI) on their packaging. Higher-risk devices, including MD Classes IIa, IIb, and III, as well as IVD Class D, already require UDIs on their packaging, with the obligation for reusable Class IIa and IIb devices to also feature a UDI on the device itself beginning 26 May 2025. The requirement for Class III devices has been in place since 2023. The UDI enhances traceability and safety, must be included in the Declaration of Conformity (DoC), and registered in the EUDAMED database for all marketed devices. Manufacturers can choose from four designated entities—GS1 AISBL, HIBCC, ICCBBA, and IFA GmbH—to issue their UDI, which must adhere to the coding standards set by these organizations. The final deadlines for lower-risk devices to comply will be in spring 2027, while legacy devices already on the market are exempt from needing a UDI at this time.

FRANCE

Guidance Document: ANSM publishes a regulatory guide for manufacturers of ocular prostheses

The French National Agency for the Safety of Medicines and Health Products (ANSM), in collaboration with the Union of French Ocularists (Udof), has published a regulatory guide aimed at manufacturers of custom-made ocular prostheses. These prostheses, designed by ocularists to replace or cover damaged or missing eyes, are classified as medical devices and must comply with regulatory requirements applicable to custom-made devices. The guide provides clear explanations on the legal framework, patient information obligations, manufacturing steps, and post-market surveillance duties. It is intended to help ocular prosthesis manufacturers understand and fulfill their compliance responsibilities under French and EU medical device regulations.

HONG KONG

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

The Medical Device Division (MDD) of Hong Kong’s Department of Health has updated the technical reference document “TR-007: Software Medical Devices and Cybersecurity.” This update reflects the latest regulatory expectations and best practices regarding the development, risk management, and post-market surveillance of software as a medical device (SaMD), with an enhanced focus on cybersecurity measures. The revised guidance provides stakeholders with clearer instructions to address emerging cyber threats, protect patient data integrity, and ensure the safe and effective use of software medical devices within Hong Kong’s Medical Device Administrative Control System (MDACS). Manufacturers, developers, and distributors are advised to review the updated TR-007 to align their compliance strategies with current regulatory standards and to mitigate cybersecurity risks effectively.

Guidance Document: Definitions and Abbreviations for the Medical Device Administrative Control System” (GN-00) and “Overview of the Medical Device Administrative Control System” (GN-01)

The Medical Device Division (MDD) of Hong Kong’s Department of Health has announced immediate updates to two core guidance documents under the Medical Device Administrative Control System (MDACS): “GN-00: Definitions and Abbreviations for the Medical Device Administrative Control System” and “GN-01: Overview of the Medical Device Administrative Control System.” These updates aim to clarify key regulatory terms, standardize abbreviations, and enhance understanding of the structure and functioning of the MDACS framework. By refining definitions and updating the system overview, the revisions support improved transparency, consistency, and alignment with international regulatory expectations. Stakeholders involved in the manufacturing, distribution, or use of medical devices in Hong Kong are advised to review the updated documents promptly to ensure compliance and informed engagement with the MDACS.

Technical Reference “Personalised Medical Devices” (TR-009) has been issued

The Medical Device Division (MDD) of Hong Kong’s Department of Health has issued a new technical reference document titled “TR-009: Personalized Medical Devices.” This guidance provides detailed information on the regulatory framework applicable to personalized medical devices under Hong Kong’s Medical Device Administrative Control System (MDACS). It covers important aspects such as definitions, classification, design considerations, manufacturing processes, and post-market controls specific to devices customized for individual patients. The document aims to help manufacturers and stakeholders navigate regulatory requirements for personalized devices, balancing innovation with patient safety and compliance.

Department of Health (DH) organizes International Medical Device Regulatory Forum to promote advancement of health through research and technology

On May 28, 2025, the Hong Kong Department of Health (DH) and the Chinese University of Hong Kong (CUHK) co-hosted the Hong Kong International Medical Device Regulatory Forum, bringing together over 200 experts from regulatory bodies, academia, and industry to discuss medical device innovation and AI regulation. DH highlighted recent guidance on AI and cybersecurity and noted that 22 AI medical devices are now listed under the voluntary Medical Device Administrative Control System (MDACS). The forum also introduced plans for the upcoming Hong Kong Centre for Medical Products Regulation and emphasized Hong Kong’s strategic role in global health innovation through initiatives like the Hetao Innovation Zone.

NORWAY

Notified body for medical devices designated in Norway.

The Norwegian Medical Products Agency (NOMA) has appointed DNV Product Assurance AS as a notified body under Regulation (EU) 2017/746 for in vitro diagnostic medical devices (IVDR), having already been designated under the Medical Device Regulation (MDR). IVD devices, which include tests for infections, diabetes, cholesterol, cancer markers, and genetic testing, are essential for accurate diagnoses and tailored treatments. The designation of notified bodies is vital for ensuring adequate certification capacity for these devices. Notified bodies assess compliance with regulatory requirements to ensure the safety and effectiveness of medical devices before they enter the market. This designation is significant for enhancing patient safety, fostering innovation, and supporting growth in Norway’s health technology sector. Notified bodies are selected by national authorities in collaboration with the European Commission, adhering to strict criteria regarding resources, quality management, and independence.

PORTUGAL

Exemption from Portuguese info in graphical interface of medical device for professional use

The Commission and Member States have developed MDR and IVDR tables to assist manufacturers, especially small and medium-sized enterprises, in understanding the language requirements for accompanying information and instructions for medical devices and in vitro diagnostic medical devices in various countries. These tables outline the specific language requirements for each Member State. The last column addresses language requirements related to graphic user interfaces (GUIs), such as apps, noting that while there is no dedicated article in MDR/IVDR, some countries have their own regulations regarding GUIs. For example, external readout devices can capture screenshots to illustrate a GUI, like the “Save” function on a brain pressure measurement device. The information for this function must be provided in the local language and does not require translation; alternatively, an icon could represent the function, with its meaning detailed in the instructions for use (IFU).

SINGAPORE

Public Consultation on Exemption from Licensing and Registration for AI Software as Medical Device by Public Healthcare Entities.

The Ministry of Food and Drug Safety (MFDS) of South Korea has initiated a Technical Support Project aimed at enhancing the GMP operational capabilities of domestic medical device manufacturers by assisting them in adopting international quality management standards. The project offers customized technical support, including over 160 tailored sessions and multiple training programs on overseas certifications and quality management practices. Additionally, the MFDS will develop usability evaluation guidelines to help manufacturers and importers ensure device safety and user satisfaction. This initiative supports manufacturers seeking new approvals or export expansion and reflects South Korea’s commitment to strengthening medical device quality and global competitiveness.

SOUTH KOREA

Rapid growth of digital medical device market such as AI ultrasound imaging diagnostic device and software.

The Ministry of Food and Drug Safety (MFDS) of South Korea reported a significant increase in the production and export of digital medical devices—including AI-driven ultrasound imaging and diagnostic software—in 2024, with growth rates of 32.4% and 45.4% respectively. This surge comes ahead of the implementation of the Digital Medical Products Act, which takes effect in January 2025 and introduces a dedicated regulatory framework for software-centered medical devices. The Act formally reclassifies these products to ensure they meet specific safety, performance, and quality requirements. The update reflects South Korea’s strategic regulatory shift toward aligning with global standards for digital and AI-based technologies. As such, this development constitutes a key regulatory update, highlighting the MFDS’s commitment to supporting innovation while strengthening oversight in the digital health sector.

Implementation of technical support project for introduction of international standards for medical device quality management.

The Ministry of Food and Drug Safety (MFDS) of South Korea has initiated a Technical Support Project aimed at enhancing the GMP operational capabilities of domestic medical device manufacturers by assisting them in adopting international quality management standards. The project offers customized technical support, including over 160 tailored sessions and multiple training programs on overseas certifications and quality management practices. Additionally, the MFDS will develop usability evaluation guidelines to help manufacturers and importers ensure device safety and user satisfaction. This initiative supports manufacturers seeking new approvals or export expansion and reflects South Korea’s commitment to strengthening medical device quality and global competitiveness.

SRILANKA

GMP Inspection Waiver for Listed and Class 1 Medical Device Manufacturers by NMRA

The National Medicines Regulatory Authority (NMRA) has announced a waiver of the Good Manufacturing Practice (GMP) inspection requirement for manufacturing sites producing Listed and Class 1 medical devices. Effective from May 10, 2025, local manufacturers in this category can apply for product registration without prior GMP approval, provided they submit required documentation—including a Site Master File, business registration, site layout, manufacturing activities description, and product list—to the Manufacturing Regulatory Division (MFRD). Upon review, MFRD will issue a GMP Waiver Document that replaces the traditional GMP certificate for registration purposes. This waiver is a temporary measure valid for two years (until May 9, 2027), during which manufacturers are expected to obtain ISO 9001 certification. After this period, NMRA will only accept ISO 9001 in lieu of GMP inspections for these device categories. This regulatory shift aims to streamline the registration process while encouraging quality management system adoption among manufacturers.

UNITED KINGDOM

Guidance Document: Manufacturer’s Online Reporting Environment (MORE)

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has introduced significant improvements to post-market surveillance (PMS) through the Manufacturer’s Online Reporting Environment (MORE) platform and the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024. Effective 16 June 2025, manufacturers must report adverse incidents for devices in Great Britain (GB) and Northern Ireland exclusively through the MORE portal. The system centralizes incident reporting, supports automated API integration, and enables structured submission of Manufacturer Incident Reports (MIRs) and Field Safety Corrective Actions (FSCAs). The enhanced PMS legislation strengthens MHRA’s ability to detect trends, identify new risks, and act swiftly to mitigate safety concerns—ultimately improving patient safety and device traceability in the UK medical device landscape