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

NMPA’s final inspection principles set 200 graded items and distinguish licensing failure from post-market production suspension. From 1 November 2026, specific pending applications and uninspected Class I filings move to the revised GMP; existing specialised annexes also remain applicable.

FDA has finalised manufacturer guidance for blood collection, processing and storage systems used with the buffy coat method. The nonbinding recommendations address pathway selection, separation timing, materials and solutions, and the evidence supporting the proposed system.

HSA GN-15 Revision 14 requires an Annex 4 declaration across the listed Class B/C/D registration routes, including Full evaluation. The guidance also sets out current Priority Review focus areas and the safety criterion for Class C standalone medical mobile applications.

The COMBINE Project 2 guide explains safety reporting for studies spanning multiple EU regulatory frameworks. It recommends a 7-calendar-day device reporting timeline, while preserving statutory CTR notifications, national requirements and separate sponsor responsibilities.

Pure Global has launched a flat-fee pricing model for medical device registration that simplifies global expansion across 13 key markets. With AI-assisted dossier preparation and in-country representation included, manufacturers can easily plan their market access budgets.

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.