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

The CMS and FDA RAPID Coverage Pathway 2026 accelerates Medicare access to breakthrough medical devices by aligning regulatory approval and coverage decisions. It enables early CMS–FDA collaboration, shared clinical evidence, and same-day proposed coverage decisions upon FDA authorization. Eligible devices include certain Class II and Class III breakthrough devices studied in Medicare populations, reducing coverage timelines from over a year to approximately two months.

Swissmedic’s 2026 focus campaign targets post-market surveillance documentation for randomly selected Class IIa, IIb, and III medical devices in Switzerland. Manufacturers and Swiss Authorized Representatives must provide PMS, PSUR, PMCF, and vigilance data for review. The campaign strengthens regulatory oversight of higher-risk devices and ensures compliance with Swiss post-market surveillance requirements.

ISO 10993-6:2026 and ISO 10993-7:2026 update biocompatibility testing with new definitions, risk-based approaches, and expanded test methods including histopathology and ethylene oxide residual analysis. ISO 14155:2026 replaces the 2020 version with immediate effect, strengthening clinical investigation requirements including risk management, Clinical Event Committees, and Data Monitoring Committees. Manufacturers and sponsors must update QMS and clinical documentation accordingly.

The EU MDCG 2026 updates bring important clarifications to medical device classification under MDR (EU) 2017/745 and revisions to the European Medical Device Nomenclature (EMDN). These changes improve guidance on classification rules, intended use interpretation, and the correct assignment of EMDN codes used in EUDAMED and technical documentation.

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.