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

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.

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.