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

Swissmedic’s 2025 update to the Good Practices for Endoscope Reprocessing (GPAE) clarifies legal duties under the Swiss MedDO and aligns hygiene standards with the latest science. Prompted by compliance gaps revealed in hospital inspections, the guidance requires healthcare providers to update procedures, training, and documentation.

The European Commission’s 2025 Guidance on Borderline and Classification of Medical Devices introduces key updates under MDR and IVDR, including reclassification of SARS-CoV-2 tests, new rules for electronic Instructions for Use (eIFU), and streamlined PAR forms. These changes reduce uncertainty for manufacturers, support digital compliance, and accelerate market access across the EU.

The Philippines FDA has extended its temporary suspension of 2025 medical device registration fees, granting manufacturers an additional 60 working days to register at legacy rates. This move, formalized under Department Circular No. 2025-0382, offers continued cost savings and a strategic window for market entry while the agency completes its review of the updated fee schedule.

Health Canada’s 2025 eSTAR pilot expands digital submission capabilities for Class III and IV medical devices, including IVDDs, through a guided, interactive PDF template. The initiative aims to streamline regulatory processes and test a new content conversion tool aligned with IMDRF standards. Up to 30 eligible participants will be selected to take part.

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.