Connect and stay on top of the MedTech regulatory landscape globally.

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.

Pure Global's new CTO, Ran Chen, brings over a decade of experience in building and scaling machine learning products.

Pure Global is proud to announce its inclusion in the China Business Service Providers (BSP) directory on the International Trade Administration website.

Unlock efficient market access with Pure Global & MEDIcept's collaboration. From registration to regulatory expertise, we offer comprehensive solutions worldwide. Drive growth & innovation in MedTech.

Malaysia, a key gateway to Southeast Asia, offers strategic access for businesses. Understanding medical device regulations is crucial for market entry.