It deals with the procedure for the analysis and decision of petitions for registration of medical devices, with analysis by international equivalence
Published on 04/08/2024, the new IN brings a possibility of primary registration, without the need to redo analyses already approved by international bodies. For the purpose of adopting the optimized analysis procedure, the following AREE and respective proof of registration or authorization are considered:
I – Austrália: Australia Therapeutic Goods Administration (TGA) – Australian Register of Therapeutic Goods (ARTG);
II – Canadá: Health Canada (HC) – Medical Device Licence;
III – United States of America (USA): US Food and Drug Administration (US FDA) – 510(k) Clearance, Premarket Approval (PMA) or 513(f)(2) “De Novo”; and
IV – Japão: Japan Ministry of Health, Labour and Welfare (MHLW) – Pre-market approval (Shonin).
This new IN will be effective on June 3, 2024.
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