The MDCG has published new guidance clarifying Master UDI-DI requirements for low-risk optical devices like contact lenses and spectacle frames under the MDR. The position paper outlines mandatory timelines for UDI labelling and EUDAMED registration, with full implementation phased in between 2026 and 2028.

Vietnam’s Ministry of Health has announced a temporary 50% reduction in government fees for medical device registration and licensing, effective from July 1, 2025, to December 31, 2026. The fee cut applies to new applications for circulation numbers, import/export licenses, testing certificates, and declarations of eligibility, offering cost relief for manufacturers entering or expanding in the Vietnamese market.

Brazil’s health authority Anvisa has launched its national UDI system, Siud, marking a major step toward global alignment in medical device traceability. Starting July 2025, manufacturers must register devices in the database and apply standardized UDI labels.

COFEPRIS introduced sweeping reforms in June 2025 that streamline medical device registration for foreign manufacturers, including recognition of international approvals, expanded GMP documentation options, new homologation codes, and a 30-day review timeline. These changes mark a major step toward regulatory alignment with global standards and faster market access in Mexico.

Two June 2025 guidance documents from the European Commission’s Medical Device Coordination Group (MDCG) clarify how medical device software is defined, classified, and distributed in the EU. From tighter rules on intended purpose to platform obligations under the Digital Services Act, these updates crystallize compliance expectations for both manufacturers and app hosts.

The UK MHRA’s June 2025 updates introduce sweeping changes to post-market surveillance requirements for medical devices in Great Britain, marking the first major regulatory shift since Brexit. With new PMS regulations now in force, manufacturers must urgently update surveillance systems, incident reporting protocols, and FSCA procedures to stay compliant and maintain market access.

This week in global device regulatory news, Malaysia’s MDA issued updated ASEAN guidance on borderline products and risk-based classifications, Mexico’s COFEPRIS proposed faster equivalency pathways that accept IMDRF- and MDSAP-member approvals, and Brazil’s Anvisa cancelled IVD devices that missed the RDC 830 reclassification cutoff.

Our weekly regulatory news round-up includes the US FDA's debut of “Elsa,” an agency-wide generative-AI platform to speed reviews and boost efficiency. In addition, Mexico’s COFEPRIS announced sweeping Plan Mexico reforms aimed at digitizing procedures, reclassifying 2,200 devices, and slashing clinical-protocol review times in a bid to become a WHO-listed authority.

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