Medical Devices – USA, Europe, Asia and ROW Regulatory News – Mar. 2024

USA

Accreditation Scheme for Conformity Assessment (ASCA)

The FDA’s Center for Devices and Radiological Health (CDRH) continues encouraging device sponsors to rely on FDA‑recognized voluntary consensus standards to streamline submissions and strengthen device quality. ASCA is being implemented in line with amendments to Section 514(d) of the FD&C Act under the Food and Drug Omnibus Reform Act of 2022 and MDUFA V. Stakeholders may request updates by emailing ASCA@fda.hhs.gov.

FDA Update on Artificial Intelligence and Machine Learning in SaMD

The FDA has issued an update outlining four focus areas for CBER, CDER, CDRH, and OCP concerning the development and use of AI across the medical product lifecycle. Agencies intend to tailor regulatory oversight to ensure patient and user safety, maintain cybersecurity, and promote innovation in AI-enabled medical products.

EUROPE

European Commission Requests Scientific Opinion on Non‑Medical Brain Stimulators

The European Commission has asked SCHEER to review risks associated with brain stimulators that have no medical purpose. Concerned Member States have proposed reclassifying these products from Class I to Class III under the MDR. SCHEER is tasked with evaluating potential hazards, including lasting structural or functional brain changes, with a final opinion expected by the end of 2025.

Updated Guidelines on Phthalates in Medical Devices

SCHEER has issued the first update to the EU’s guidelines on the benefit–risk assessment of CMR/ED phthalates used in medical devices, as required every five years under the MDR. The updated methodology helps manufacturers justify continued use of such substances above the 0.1% threshold when necessary for the device’s performance.

Overview of National Language Requirements for Device Manufacturers

The European Commission has published an overview of language requirements applicable to manufacturers under the MDR. Member States may allow information to be provided in alternative languages (e.g., English) when safe device use is not compromised, particularly for professional‑use devices.

EPA Finalizes Rule to Reduce Ethylene Oxide Emissions

EPA has finalized amendments to the NESHAP for ethylene oxide commercial sterilizers. The rule is expected to significantly reduce public exposure and associated cancer risks while maintaining supply chain continuity for sterilized medical products.

Harmonized Standards for Medical Device Sterilization Adopted

The European Commission has adopted implementing decisions incorporating new harmonized standards that cover sterilization of medical devices and IVDs. Compliance with these standards helps demonstrate conformity with MDR/IVDR requirements.

MDCG 2024‑3: Guidance on Clinical Investigation Plans

New MDCG guidance describes the required structure and content of Clinical Investigation Plans submitted under Article 70(1) MDR. It emphasizes scientifically robust methodology, adequate sample sizes, and designs that support assessment of device safety, performance, and benefit–risk.

AUSTRALIA

Guidance on Supporting Documentation for ARTG Inclusion

The TGA has clarified documentation requirements for device inclusion applications, in addition to previously submitted manufacturer evidence. Guidance outlines the specific product assessment evidence required for inclusion.

<'h3 style="background:#e2e2e2;padding:12px;font-weight:bold;">BRAZIL

Updated Essential Safety and Performance Requirements for Devices

Anvisa has revised RDC 546/2021, enhancing its standards for evaluating safety and performance of medical devices and supporting clearer evidence expectations for product registration.

Extension of GMP Certificate Validity

Anvisa has extended the validity of MDSAP‑based Good Manufacturing Practices certificates for device manufacturers from two to four years.

CANADA

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Regulatory Enrolment Process (REP) for Medical Devices

Health Canada has released updated guidance on using REP to streamline submission intake processes, enabling electronic regulatory transactions through the CESG.

CHINA

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Calls for Participation in New IVD Registration Guidelines

Authorities are inviting qualified organizations to contribute to multiple new IVD registration review guidelines, including those for KRAS mutation detection and HTLV antibody testing. Interested entities must submit information forms by the designated deadline.

Release of Revised Guiding Principles for High‑Frequency Surgical Equipment

Updated guidelines clarify the scope and clinical applicability of high‑frequency surgical equipment and specify exclusions such as radiofrequency ablation and non‑ablative aesthetic systems.

Guidance on Medical Device Usability Engineering

New usability engineering guidelines apply to Class II and III medical devices. They outline expectations for user interface design, human factors considerations, and safe device operation under expected conditions.

Multiple Additional Guiding Principles Released

China has issued numerous new guidelines covering corneal topography devices, animal studies for laparoscopic surgical systems, three‑dimensional endoscopes, and devices incorporating medical light sources.

CZECH REPUBLIC

Updated Procedure for Accessing ISZP

The Czech regulator has updated requirements for requesting access to the ISZP regulatory system. Forms are available via SÚKL Access.

FINLAND

New Website on Medical Device Marketing Requirements

Fimea has launched a website summarizing national and EU requirements for marketing medical devices, including guidance on permissible claims and best practices.

Importance of Proper Device Maintenance

Fimea stresses adherence to manufacturer maintenance instructions, citing increased findings of improper servicing that could compromise safety.

GERMANY

FAQs on Changes Stemming from DigiG

German authorities have published FAQs describing major updates related to digital health applications (DiGA) and their expanded integration into clinical care pathways.

HONG KONG

New Code of Practice for Listed Distributors (COP‑05)

Hong Kong has introduced COP‑05, outlining the obligations of distributors under MDACS and their responsibilities for demonstrating compliance.

Custom‑Made Devices Excluded from MDACS

As of 2 April 2024, custom‑made medical devices are no longer within MDACS scope.

Recognition of HSA Approvals from Singapore

Hong Kong’s MDD will now accept HSA approvals as evidence of conformity with MDACS essential safety principles.

JAPAN

Publication of Foreign Manufacturer Certification/Registration Numbers

Japan has updated its publication of certification and registration numbers for foreign manufacturers of medical devices and IVDs. Importers must verify a manufacturer’s status before submissions.

MALAYSIA

Medical Device (Exemption) Order 2024

The Order outlines exemptions relating to device registration, establishment licensing, and conformity assessment for certain Class A devices.

MEXICO

Mexico Joins IMDRF

Cofepris has announced Mexico’s new affiliate membership in the International Medical Device Regulators Forum, supporting regulatory alignment and reducing trade barriers.

PHILIPPINES

Extension of Transitory Provisions for Medical Device Retailer Licensing

FDA Circular 2021‑021‑A extends deadlines for manufacturers, traders, and distributors selling devices directly to the public to secure amended LTOs through the new eServices system.

SAUDI ARABIA

Guidance on Development of In‑House IVDs

SFDA has released guidance covering development, documentation, and post‑market requirements for in‑house IVDs and point‑of‑care systems.

Guidance for Surgical Sutures

New SFDA guidance outlines documentation requirements for demonstrating compliance with essential safety and performance standards for sutures, with or without needles.

SINGAPORE

Multiple Updated Guidance Documents Published by HSA

HSA has released revised versions of:

• GN‑15 (Product Registration Procedures) 
• GL‑04 (Software Medical Devices – Lifecycle Approach) 
• GN‑17 and GN‑18 (ASEAN CSDT Submission Guidance) 
• TR‑01 and TR‑02 (CSDT Content Requirements) 
• E‑Submission Guides for ASEAN CSDT and IMDRF ToC formats 

SOUTH KOREA

Partial Amendment to Enforcement Rules of the Medical Device Act

The amendment updates delegated provisions, classification processes, and documentation requirements for manufacturing license applications, including electronic submissions.

SPAIN

Updated Instructions for NorBed Kid Pediatric Hospital Beds

AEMPS has issued revised instructions for safe installation and use of sliding side rails following reported incidents linked to unclear user manual guidance.

UK

Roadmap Toward Future UK Medical Device Regulations

The UK has released an updated roadmap outlining timelines for implementing new medical device regulations, with priority post‑market surveillance measures anticipated in 2024 and core regulation rollouts expected in 2025.

Updated Guidance on UK Approved Bodies

The UK has updated its list of approved bodies authorized to conduct conformity assessments under UK MDR 2002.

Guidance on Device Regulation in Northern Ireland

Updated guidance outlines regulatory expectations for placing medical devices and IVDs on the Northern Ireland market under the amended 2024 framework.

Guidance on Notifying MHRA of Clinical Investigations Manufacturers must notify the MHRA at least 60 days before beginning clinical investigations intended to support UKCA/CE/CE UKNI marking.