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

Anvisa’s 2025 Modernization Plan reduces the medical device post-registration backlog by 40%, shortens review times for biological products and clinical research, and clears radiopharmaceutical pipelines. The agency is investing 25 million reais in AI and hiring 102 new specialists, marking its largest team expansion since 2014. Queues are expected to be cut in half within six months, with full normalization within a year, improving efficiency, predictability, and regulatory support for medical device manufacturers in Brazil.

The FDA Pre-RFD Guidance 2025 updates the 2018 version for combination product sponsors seeking preliminary, non-binding feedback. The guidance explains how to submit a Pre-Request for Designation, clarifying regulatory classification, responsible FDA centers (CDER, CBER, or CDRH), and meeting elements including materials, request format, and timelines. Early interaction supports planning, confirms regulatory assignment, and helps mitigate risks in development and marketing applications for drugs, devices, biologics, or combination products.

ISO 10993-1:2025 (Edition 6) revises the biological evaluation of medical devices, replacing Table A1 with a risk-based, lifecycle approach aligned with ISO 14971. Manufacturers must now focus on identifying actual biological hazards, exposure duration, and material characteristics, providing scientific justification for all tests. The update emphasizes safety throughout the device lifecycle rather than minimum required tests, shaping a more flexible, scientifically grounded approach for compliance and regulatory submissions.

The EU MDR 2017/745 and IVDR 2017/746 pilot coordinated assessment lets sponsors submit one application for multinational clinical investigations and performance studies. The system streamlines approvals, reduces duplicative national submissions, and prepares Member States for mandatory coordinated assessment. Eligibility includes Class III and certain Class II devices, as well as IVD performance studies under Article 58. Sponsors must confirm intended use, documentation, and risk class before applying.

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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