USA
Guidance on Premarket Approval (PMA) and Humanitarian Device Exemption (HDE) Modular Review
The FDA has issued guidance outlining the modular review pathway for Premarket Approval (PMA) applications and Humanitarian Device Exemptions (HDE). The modular approach allows applicants to submit sections of an application incrementally rather than as a complete package. This pathway serves as an alternative to the traditional PMA and HDE review processes; however, it does not apply to PMA or HDE supplements.
Guidance on Notification of Permanent Discontinuance or Manufacturing Interruptions under Section 506J of the FD&C Act
This guidance addresses manufacturers’ obligations under Section 506J of the Federal Food, Drug, and Cosmetic Act, introduced through the CARES Act. Device manufacturers must notify the FDA of permanent discontinuations or temporary manufacturing interruptions that could lead to supply disruptions during, or in advance of, a declared public health emergency (PHE). The objective is to support proactive mitigation of potential shortages. While the guidance establishes baseline notification requirements, the FDA may issue additional, PHE-specific instructions as needed. Manufacturers are also encouraged to voluntarily provide supplementary details to strengthen the agency’s response efforts.
CANADA
Update to Validation Rules for Regulatory Transactions in eCTD Format
Health Canada has revised validation rules for regulatory submissions in electronic Common Technical Document (eCTD) format. These updates reflect recent and anticipated process changes, aligning with existing guidance, including documentation related to eCTD preparation and the Regulatory Enrollment Process. The revised validation framework is designed to reduce submission errors and ensure completeness. Sponsors are advised to use commercially available validation tools before submission. If deficiencies are identified, Health Canada will issue an eCTD Validation Report outlining the specific errors.
EUROPE
Advice on SARS-CoV-2 at the Request of the Medical Device Coordination Group
The In Vitro Diagnostic (IVD) expert panel has advised that although SARS-CoV-2 continues to cause serious illness, it no longer represents a significant mortality threat to the general European population. This updated epidemiological assessment may affect the classification of SARS-CoV-2 diagnostic tests under Regulation (EU) 2017/746. Manufacturers should evaluate whether reclassification is warranted, consult their notified bodies where necessary, and ensure ongoing compliance with classification rules. The MDCG guidance on IVD classification (MDCG 2020-16) is currently under revision but remains non-binding. Risk classification decisions should be made individually, taking into account the current public health context.
Updated Guidance in the European Medical Device Nomenclature (EMDN) Section
Revised and new guidance documents are available to assist stakeholders in implementing Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). Most documents are endorsed by the Medical Device Coordination Group (MDCG) and follow a standardized structure. Although not legally binding, they promote harmonized interpretation and consistent regulatory application. Guidance documents are periodically reviewed, with outdated versions archived and new updates clearly identified.
Revised PAR Templates and Notified Body (NB) Designation Application Forms
The Notified Bodies section now includes updated Performance Assessment Report (PAR) templates, revised application forms for designation as a Notified Body, and corresponding annexes. These updates are intended to streamline conformity assessment and designation procedures under the MDR and IVDR frameworks.
Q&A on Vigilance Terminology under MDR and IVDR
A newly issued Questions and Answers document clarifies vigilance-related terminology, reporting deadlines, and manufacturer responsibilities under Regulations (EU) 2017/745 and 2017/746. The objective is to support the consistent implementation of vigilance requirements across EU Member States.
BELGIUM
Mandatory Notification of Supply Interruptions
Effective January 10, 2025, manufacturers must notify authorities of any interruption or discontinuation in the supply of medical devices or in vitro diagnostic devices within the European Union when such absence could reasonably be expected to pose a risk to patient or public health in one or more Member States.
CZECH REPUBLIC
Notice to Medical Device Manufacturers
As of January 10, 2025, selected provisions of Regulation (EU) 2024/1860 apply, requiring manufacturers to report production interruptions or discontinuations of medical devices and IVDs to the State Institute for Medicines Control under specified circumstances. These reporting obligations are incorporated into Article 10a of Regulations (EU) 2017/745 and 2017/746.
FRANCE
Exceptional Market Access for Non-CE-Marked Devices
From January 27, 2025, manufacturers seeking exceptional authorization to place non-CE-marked medical devices on the French market must use a newly introduced simplified procedure form. These exemptions, granted under Article 59 of Regulation (EU) 2017/745, permit temporary market access where a demonstrable clinical benefit exists for patients. The National Agency for the Safety of Medicines and Health Products (ANSM) evaluates submissions based on supporting evidence and risk considerations. The new standardized format is expected to streamline assessments and shorten review timelines. A dedicated procedure for in vitro diagnostic devices is forthcoming.
SWITZERLAND
Amendments to the IVD and Medical Devices Ordinances
Switzerland has amended its In Vitro Diagnostic Medical Devices Ordinance (IvDO) and Medical Devices Ordinance (MedDO) to further align with European Union requirements. Transitional periods for certain IVD certificates have been extended through 2027–2029, and labeling requirements for professional-use devices have been simplified. Healthcare institutions now have until December 31, 2030, to justify in-house tests. Notably, the EU requirement to notify supply interruptions has not been incorporated into Swiss law. Device registration requirements under MedDO and IvDO will become applicable on July 1, 2026.
ASIA
CHINA
Comprehensive Regulatory Reform for Drugs and Medical Devices
China has issued a reform guideline aimed at strengthening oversight of pharmaceuticals and medical devices while enhancing global competitiveness. Released by the State Council’s General Office, the plan sets milestones for 2027 to reinforce legal frameworks, improve efficiency in the review and approval of innovative products, and ensure lifecycle safety monitoring. By 2035, the objectives include ensuring product safety, efficacy, accessibility, and regulatory modernization. The reform outlines 24 measures across five strategic areas: fostering research and innovation, optimizing review pathways, strengthening compliance, expanding international collaboration, and modernizing the regulatory system.
HONG KONG
Approval of COVID-19 Rapid Antigen Tests
Hong Kong’s Medical Devices Division has approved selected COVID-19 Rapid Antigen Tests (RATs) under its administrative Medical Device Management System. These products meet applicable standards for safety, quality, and performance. The Department of Health continues to monitor safety alerts issued by international regulatory authorities and the World Health Organization, and manages reports of adverse incidents associated with these devices.
INDIA
Draft Update on Risk-Based Classification of Medical Devices
India’s Central Drugs Standard Control Organization (CDSCO) has released a draft revision to its risk-based classification framework for medical devices for public consultation. The proposal covers interventional radiology, radiotherapy, oncology, and Class A devices. Class A, the largest category with 803 devices, includes non-sterile and non-measuring products such as stethoscopes and enema bags. Proposed classifications also address 375 devices across the other three categories. Interventional radiology devices are primarily classified as Class B and C, while 35 high-risk Class D devices are mainly within radiotherapy, with some in interventional radiology and oncology. The draft, dated January 6, is open for stakeholder comments for 30 days.
Implementation of Merged Risk Classifications
CDSCO has also implemented a harmonized risk-based classification structure under India’s Medical Devices Rules, 2017. The consolidation of classifications aims to improve regulatory clarity, alignment, and compliance within the national framework.
SOUTH KOREA
Preliminary Notice on Revisions to Medical Device Act Enforcement Regulations
South Korea has issued a preliminary notice proposing amendments to the Enforcement Regulations of the Medical Device Act. The revisions are intended to accelerate market access for innovative devices, enhance administrative efficiency, and reduce financial burdens on manufacturers. Proposed changes include fee adjustments for newly developed devices, lower pre-review costs, and exemptions from repeated submission of quality manager qualification documents. Additional measures introduce penalties for false declarations and regulatory violations, as well as a reporting mechanism for promotional businesses. Stakeholders were invited to provide feedback by January 31, 2025.
THAILAND
Revised Advertising Criteria for Medical Devices
Thailand’s FDA has updated its criteria and procedures governing medical device advertising. The revisions aim to streamline the approval process while reinforcing consumer protection. Advertisements must relate strictly to approved, registered, or listed devices and present accurate, non-misleading claims. The updated framework seeks to clarify regulatory expectations, limit discretionary interpretation, and facilitate public access to reliable product information.
