ARTICLE SUMMARY:
Brazil preps for a new underlying device regulation. Excerpted from Pathways' Picks February 15: MDR in Parliament, New Brazil Regulation, China Approvals Spike.
A new underlying device regulation, RDC 751/2022, is set to take effect in Brazil March 1, consolidating and formalizing an array of updates that the regulatory agency ANVISA has initiated in recent years. The new framework is intended, in part, to further harmonize Brazil’s document requirements and risk classification rules with other countries in South America and worldwide. Most pressingly, starting March 1, companies will need to rely on updated documentation to support regulatory notifications, petitions, and other submissions. ANVISA posted links to the new materials, and a Q&A guide to the new rules, this week. The agency is also convening a webinar February 16 on 751/2022, which will replace a 2001 regulatory framework. Specific updates included in the reforms are new classification rules for software and nanomaterials, adoption of the IMDRF premarket submissions table-of-contents structure, and rules related to electronic instructions for use.
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