USA
Voluntary Malfunction Summary Reporting (VMSR) Program – The FDA’s VMSR Program allows medical device manufacturers to submit certain malfunction reports in a quarterly summary format rather than as individual reports. Participation is optional and does not require prior approval from the FDA. Manufacturers may exit the program at any time but must resume individual malfunction reporting within 30 days and update internal procedures accordingly. The program is designed to support FDA’s ability to monitor safety trends while maintaining sufficient information to identify potential safety risks. Detailed eligibility and reporting conditions are outlined in FDA guidance.
Small Entity Compliance Guide – Mammography Quality Standards Act (MQSA) Amendments – Mammography plays a critical role in early detection of breast cancer and relies on high‑quality imaging, properly trained personnel, and well‑maintained equipment. The MQSA establishes nationwide standards covering accreditation, staff qualifications, equipment performance, quality control procedures, and communication of results. Amendments finalized in 2023 require reports to include information about breast density and provide clearer summaries for both patients and healthcare providers. FDA guidance reflects current policy but is not legally binding unless specific regulatory provisions are cited.
Electronic Submission Template for De Novo Requests – FDA guidance describes the technical structure for preparing electronic De Novo classification requests. The template enables fully electronic submissions in line with Section 745A(b)(3) of the Federal Food, Drug, and Cosmetic Act and ensures that required information is organized consistently. Although the guidance does not define the detailed eSTAR interface, it establishes the framework used for formatting and submission. FDA will continue updating eSTAR as policies evolve and encourages feedback from stakeholders.
Section 513(g) Requests for Information – This guidance explains how manufacturers may request FDA feedback regarding device classification and applicable regulatory requirements under Section 513(g) of the FD&C Act. The document clarifies that FDA guidance represents the Agency’s current perspective and should be viewed as recommendations unless specific regulations state otherwise.
Acceptable Media for Electronic Product User Manuals – FDA guidance confirms that manufacturers may provide product user manuals either in paper form or electronically. The approach reflects the increasing use of digital platforms, which can improve accessibility, enable faster updates, and reduce paper use. These recommendations are advisory unless linked to specific regulatory requirements.
CANADA
Medical Device Licence (MDL) Minor Change Form – Manufacturer Name or Address Updates – Manufacturers holding active Medical Device Licences or COVID‑19 related authorizations must submit a minor change application when updating their company name or address. The guidance explains the documentation required and outlines the appropriate submission process.
COLOMBIA
Certification Visits for Hearing Aid Establishments – A national guideline has been introduced for facilities involved in the manufacturing, assembly, or repair of over‑the‑counter hearing aids. The guidance supports compliance with Resolution 5491 of 2017, which defines requirements for establishing and operating such facilities. Certification granted under this framework remains valid for five years and ensures adherence to quality standards supporting individuals with hearing impairments.
EUROPEAN UNION
Proposed Common Specifications for Class D IVDs – The European Commission has proposed updates to common specifications applicable to certain Class D in vitro diagnostic devices. The revisions expand the list of parasites and viruses of public health relevance covered by the specifications. Stakeholders were invited to submit feedback within a four‑week consultation period. If finalized, the changes would amend provisions under Regulation (EU) 2017/746.
EMA Pilot Programme for Orphan Medical Devices – The European Medicines Agency launched a pilot initiative providing free scientific advice to manufacturers and notified bodies developing orphan medical devices for rare diseases affecting up to approximately 12,000 people annually in the EU. Applications are selected using a risk‑based approach. If the program proves successful, it may become a permanent support mechanism.
CZECH REPUBLIC
Registration Reporting Obligations – Q&A – National authorities have published a set of frequently asked questions clarifying reporting duties and registration obligations for individuals and organizations engaged in medical device activities.
Survey on Electronic Instructions for Use (eIFU) – The European Commission launched a survey directed at healthcare professionals to gather feedback on potentially extending Regulation (EU) 2021/2226 to allow broader use of electronic instructions for use for devices intended for professional users, while ensuring paper copies remain available upon request.
PORTUGAL
Commission Implementing Decision (EU) 2024/2120 – UDI Designation Renewal – On 30 July 2024, the European Commission renewed for an additional five years the designation of four issuing entities authorized to operate Unique Device Identifier (UDI) systems: GS1, HIBCC, ICCBBA, and IFA. The renewal confirms that these organizations continue to meet requirements under Regulations (EU) 2017/745 and 2017/746.
Survey on Electronic Instructions for Use (eIFU) – A European Commission consultation, open until 11 October 2024, invites feedback on expanding the use of electronic instructions for devices intended for professional users while maintaining the option for free paper copies when requested.
SWITZERLAND
Alignment with EU IVDR Amendments – Swissmedic has aligned national measures with Regulation (EU) 2024/1860, extending the validity of certificates for certain in vitro diagnostic devices until 2027–2029 due to capacity limitations among notified bodies. Switzerland will apply similar transitional provisions to help prevent disruptions in product availability. Full device registration requirements are expected to take effect in 2026.
Launch of ‘swissdamed’ Database – On 6 August 2024, Swissmedic introduced the first module of its new medical device database, swissdamed. The initial ‘Actors’ module allows economic operators to complete online registration. Additional modules, including a ‘Devices’ module, will be introduced progressively beginning in 2025, with mandatory registration once the system is fully operational.
UNITED KINGDOM
Clinical Investigation Notification – MHRA Update – Updated guidance explains the procedure for notifying the MHRA about planned clinical investigations. Manufacturers seeking UKCA, CE, or CE UKNI marking must submit a notification at least 60 days before initiating the investigation.
Vigilance Guidance – Electronic Cigarettes – Under the Tobacco and Related Products Regulations 2016, manufacturers and importers must notify the MHRA prior to marketing electronic cigarette products. Companies are also required to maintain systems to collect information about suspected adverse effects and must take corrective actions such as product withdrawal or recall if safety concerns arise.
Export of Medical Devices – Certificate of Free Sale – Updated guidance clarifies the process for obtaining a Certificate of Free Sale for exporting medical devices. The MHRA issues certificates only for devices that are registered in the UK and does not verify compliance with regulatory requirements in the importing country.
HONG KONG
Updated Classification of General Medical Devices – Under the Medical Device Administrative Control System, general medical devices are categorized into four risk classes (Class I to Class IV). The most recent update revises Rule 14 under Clause 7.1 to refine classification criteria.
INDIA
Online Portals for Adverse Drug Monitoring and Pharmacopoeia – India has introduced two new digital platforms: one supporting the Adverse Drug Monitoring System (ADRMS) and another providing online access to Indian Pharmacopoeia standards. The ADRMS platform enables patients, healthcare professionals, and industry stakeholders to report adverse events associated with medicines and medical devices more efficiently.
