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

USA

1. Premarket Approval Application and Humanitarian Device Exemption Modular Review Guidance

The FDA has released updated guidance outlining the modular review process for PMA and HDE submissions. This approach allows applicants to submit segments of their application in modules for earlier feedback, rather than submitting a complete application at once. The guidance clarifies that this pathway is not applicable to supplemental submissions.

2. Guidance on Reporting Permanent Discontinuation or Production Interruptions (Section 506J)

Under Section 506J, manufacturers must inform the FDA when intending to permanently stop or temporarily interrupt the manufacture of devices where this could lead to supply shortages during a public health emergency. The guidance emphasizes timely notifications and encourages providing additional context to support FDA’s mitigation efforts.

CANADA

Revised eCTD Validation Requirements

Health Canada has updated its validation rules for electronic submissions in eCTD format. Sponsors should use validation tools to confirm compliance before submitting. If a transaction fails validation, the agency will provide a report identifying necessary corrections to ensure proper processing.

EUROPE

1. SARS‑CoV‑2 Advisory from IVD Expert Panel

The expert panel has advised that while SARS‑CoV‑2 still causes illness, it no longer presents a high mortality risk for most of the EU population. This evolving context may influence the classification of related IVD tests under IVDR. Manufacturers should reassess device classification and seek guidance from their notified body where needed.

2. Updates Published in the EMDN Guidance Collection

New and revised documents supporting MDR and IVDR implementation have been published. These materials provide harmonized guidance for consistent regulatory interpretation, though they are non-binding.

3. Updated Notified Body Application Templates

Revised Performance Assessment Report templates and designation application forms are now available to streamline the notified body designation and assessment process.

4. Vigilance Q&A under MDR and IVDR

A new Q&A publication provides clarifications on terminology, reporting expectations, and manufacturer responsibilities for vigilance activities across the EU.

BELGIUM

Mandatory Notification of Supply Interruptions

From January 10, 2025, manufacturers must notify authorities of any supply interruption or discontinuation of medical or IVD devices where a shortage could impact patient or public health in one or more EU member states.

CZECH REPUBLIC

New Reporting Requirements for Device Production Changes

From January 10, 2025, manufacturers are required to report significant production interruptions or terminations to the State Institute for Drug Control, in line with MDR and IVDR provisions.

FRANCE

Simplified Procedure for Exceptional Access of Non‑CE‑Marked Devices

Effective January 27, 2025, requests to place non‑CE‑marked devices on the market under exceptional access conditions must follow a standardized simplified application format. The aim is to improve efficiency and reduce assessment timelines.

SWITZERLAND

Regulatory Amendments to Medical Device Ordinances

Switzerland has updated its IVD and medical device regulatory framework to align with EU timelines. Transition periods for certain IVD certificates have been extended, and the deadline for justification of in‑house tests is now December 31, 2030. Device registration obligations take effect July 1, 2026.

ASIA

CHINA

Regulatory Reform to Strengthen Innovation and Oversight

China has issued new guidelines aiming to modernize its drug and device regulatory system. Key objectives include improving review efficiency, enhancing lifecycle quality oversight, expanding global collaboration, and supporting industry innovation leading up to 2035.

HONG KONG

Approval Status of COVID‑19 Rapid Antigen Tests

Hong Kong’s Medical Devices Division continues to approve and monitor COVID‑19 rapid antigen tests that meet established quality, safety, and performance criteria. Incident reports and global safety alerts continue to inform regulatory oversight.

INDIA

Public Consultation on Risk Classification Updates

CDSCO has released a draft update to the risk classification of various medical device categories, including interventional radiology, radiotherapy, oncology, and Class A devices. Stakeholders are invited to provide feedback within the consultation period.

SOUTH KOREA

Proposed Revision of Medical Device Act Enforcement Regulations

South Korea has issued a preliminary notice proposing fee reductions, documentation simplifications, and new penalties for non-compliance within the medical device regulatory framework. Public comments are open until January 31, 2025.

THAILAND

Revised Advertising Rules and Permit Streamlining

The Thai FDA has revised advertising standards for medical devices to ensure that promotional claims are accurate, factual, and non-misleading. The permit application pathway has also been simplified to support clearer regulatory expectations and consumer safety.