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

Malaysia’s Medical Device Authority (MDA) has launched its first regulatory sandbox, creating a controlled environment for testing AI-driven medical technologies. The initiative lets developers validate innovations under real-world conditions while MDA monitors safety, compliance, and performance. By bridging regulatory oversight with innovation, the sandbox is designed to fast-track safe, patient-centric devices into Malaysia’s healthcare system.

Swissmedic’s 2024 Hospital Inspections Report reveals widespread compliance gaps in Swiss hospitals’ medical device management, from weak quality systems and staff training to cybersecurity risks and inadequate vigilance reporting. Resource constraints, structural inefficiencies, and workforce shortages are cited as root causes. To close these gaps, Swissmedic urges hospitals to strengthen training, infrastructure, cybersecurity, and reporting practices to safeguard patient safety and regulatory compliance.

The European Commission’s MDCG 2024-14 Rev.1, published in August 2025, extends the compliance deadline for applying Master UDI-DI to contact lenses until 9 November 2026. The revision also references new guidance, including MDCG 2025-7 and resources on highly individualised devices, giving manufacturers more clarity. With extra time to update labeling, documentation, and vigilance processes, companies should use this transition period to prepare for full MDR compliance.

Mexico’s regulatory authority, COFEPRIS, has issued new measures to simplify medical device registration, including clearer application codes by risk class and reduced approval timelines. These updates aim to streamline market access for both domestic and international manufacturers while maintaining regulatory oversight.

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.