The Escalator: Zealand Pharma, GT Biopharma, PointClickCare and more

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.