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

ANVISA’s 2025 regulation reclassifies sodium-chloride saline solutions for nasal irrigation as Class IV medical devices under RDC 751/2022. Companies must complete transition their registrations from medicines to medical devices by May 30 2026. The rule clarifies transition conditions, GMP applicability, and stock-depletion policies, ensuring safer products and regulatory alignment with international standards.

Implementing Decision (EU) 2025/2078 updates harmonised standards for surgical drapes, gowns, clean air suits, medical face masks, and sterilizers under the EU MDR. The revised EN 13795, EN 14683, and EN 14180 standards ensure product safety, quality, and performance in line with the latest scientific developments. Manufacturers should update testing and documentation to maintain conformity and regulatory compliance.

Malaysia’s Medical Device (Amendment) Regulations 2025 [P.U.(A) 330] raise Class A medical device application fees from RM 100 to RM 500 and add a RM 750 registration fee effective 1 January 2026. Manufacturers must submit before 10 December 2025 to keep the current rate. The change supports MDA’s cost-recovery model and strengthens post-market surveillance in Malaysia’s device sector.

The UK MHRA’s 2026 DORS Fees Guidance introduces annual medical device registration fees based on GMDN Level 2 categories. Manufacturers must update and verify registrations before 30 March 2026 and pay fees via DORS within 90 days. The change replaces one-off charges with an annual, category-based model aligned with MHRA post-market surveillance.

Pure Global has launched AI Builder, a proprietary automation platform that cuts medical device dossier preparation time by up to 75%. The launch introduces a new flat annual pricing model and marks a major step toward on-demand, AI-powered global medical device registration.

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.