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

ANVISA clarifies recognized-standard evidence, voluntary use, and manufacturer responsibility. Its current linked list covers orthopedic implant materials.

Australia’s F2026L01167 adds clause 2.2A for specified non-invasive, saline-only flush and patency devices from 8 September 2026. Kinds included because of earlier applications have a five-year transition. From 1 November 2026, the CDSS exemption has five statutory limbs. Compare the amended wording, application dates and unchanged exemption conditions.

NMPA Announcement No. 107 of 2025 replaces the 2014 medical device GMP on 1 November 2026. The revised text has 15 chapters and 132 articles, including three added chapters and separate production and market release responsibilities. The text does not specify any additional grace period after that date. Hubei and Hunan have preparation schedules.

Hong Kong revised GN-01, GN-04, GN-07, GN-08 and GN-09 and five Codes of Practice, effective 1 September 2026. The package addresses certificate verification, conditional approvals and local-manufacturer inspections. GN-08 states five-year listing validity, but COP-03 contains conflicting renewal wording that manufacturers should clarify with MDD.

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.