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ANMAT Disposición 6403/2026, effective 7 October 2026, approves guidelines and a certificate model for foreign medical device and IVD plants outside the specified MERCOSUR regime. INPM has 40 working days for initial evaluation, with clock stops for additional information or verification. Applications require ISO 13485 evidence and proof of the accreditation body's network membership.

The European Commission has selected two mitral valve replacement systems from Edwards Lifesciences and Highlife SAS for its first medical device joint clinical assessments. Selection follows certification; the developer's 100-day dossier period starts with the Commission's submission request, not the selection decision.

HSA's GN-15 Revision 15 adds a Premarket Submission Checklist for non-Immediate Class B/C/D applications from 1 October 2026. Its ISO 13485 footnotes now refer to Global ACI-recognized accreditation bodies instead of IAF-recognized bodies; the EU MDR/IVDR notified body alternative remains.

From 1 October 2026, new Malaysian Product Classification Letters are valid for five years. Previously issued two-year letters extend automatically to three years from their original issuance date. Letters older than five years have a transition until 1 October 2027 to submit a renewal application, provided all letter information is unchanged.

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.