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

Anvisa’s 2025 medical device certificate tool replaces Sicert, offering integration with Solicita, new templates, translations, and previews. Companies must transition before December 1, 2025, when Sicert stops issuing new certificates. Certificates can be validated via QR code or Anvisa’s consultation system. The modernized process improves efficiency, security, and international alignment while reducing regulatory risk for manufacturers, importers, and distributors in Brazil.

Anvisa’s 2025 reform introduces immediate and structural measures to reduce approval backlogs for medicines, medical devices, and clinical trials. The plan includes expanding staff, upgrading systems through AnvisAI, streamlining submissions, and deploying temporary task forces and risk-based inspections through 2026.

Colombia’s INVIMA 2026 UDI-DI requirement mandates that Class IIa medical devices registered before February 2024 incorporate UDI-DI coding. The final deadline is February 9, 2026. Manufacturers should review their portfolios, follow submission instructions, and complete registration early to avoid noncompliance, additional fees, or interrupted commercialization. Compliance ensures devices remain valid under current INVIMA regulations.

The updated Team NB guidance (29 October 2025, V2) clarifies IVDR Annex IX Section 5.2 for companion diagnostics (CDx). It outlines when changes to performance, suitability, or intended use require notified body approval through a new assessment or certificate supplement, with a flowchart to help manufacturers determine which changes are reportable.

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.

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