EUROPEAN UNION

Updated EU Guidance on IVD Classification: MDCG 2020-16 Rev.4

The European Commission's Directorate-General for Health and Food Safety has published MDCG 2020-16 Rev.4 (March 2025), an updated guidance on the classification of in vitro diagnostic medical devices (IVDs) under Regulation (EU) 2017/746 (IVDR). This document clarifies classification rules set in Annex VIII and provides insights for manufacturers, notified bodies, and health institutions regarding IVD classification before market placement. The guidance ensures uniform application across the EU and considers recent regulatory updates.

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BRAZIL

Brazil Opens Public Consultation on UDI Database Management for Medical Devices

The Brazilian Health Regulatory Agency (Anvisa) has launched Public Consultation No. 1,313, published in the Official Diary of the Union on March 18, 2025. The consultation seeks feedback on a proposed Normative Instruction outlining the requirements for the transmission and management of the Unique Device Identification (UDI) Database, as mandated by RDC No. 591/2021. This initiative aligns with Anvisa’s Regulatory Agenda 2024-2025 (Topic 11.12) to enhance the availability and oversight of medical device identification data.

🔗 Access the publication here: Consulta Pública nº 1.313, DE 18 DE MARÇO DE 2025

Anvisa Suspends Mandatory Electronic Signature Requirement for Filed Documents

The Brazilian Health Regulatory Agency (Anvisa) has published Resolution RDC No. 971/2025 in the Official Diary of the Union on March 20, 2025. This resolution indefinitely suspends the requirement under Article 13 of RDC No. 947/2024, which mandated electronic signatures for documents submitted to Anvisa. As a result, the agency will now accept petitions and documents filed before the new resolution, even if they do not comply with the previous rule. Validation will follow Anvisa's current regulations.

🔗 Access the publication here: RESOLUÇÃO - RDC ANVISA Nº 971, DE 20 DE MARÇO DE 2025

Learn more about ANVISA Brazil Medical Device Registration.

CHINA

China Adjusts Regulations for Domestic Production of Imported Medical Devices

China’s National Medical Products Administration (NMPA) issued Announcement No. 30, 2025, further refining regulations for the domestic production of imported medical devices. This update optimizes registration requirements, expands eligibility criteria for domestic manufacturers, streamlines quality management system verification, and enhances support for innovative medical devices. The new rules aim to accelerate market access for foreign-developed medical technologies in China while maintaining regulatory oversight.

Learn more about China Medical Device Registration & Approval.

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