Brazil’s ANVISA to Recognize Selected Overseas Approvals
Brazil's Draft Resolution 1200, dated September 1st, 2023, outlining a streamlined process for evaluating and deciding on medical device and IVD registration requests using analyses conducted by an Equivalent Foreign Regulatory Authority, has been adopted as Normative Instruction 290. It was adopted on April 4th, 2024, and will be effective from June 4th, 2024.
The option allowing ANVISA to leverage registrations from overseas regulators for identical devices when the regulator is considered equivalent to ANVISA is only available to class III and IV devices.
The market authorizations/certifications from overseas regulators, specifically the other Full Members of the MDSAP program, with whom Brazil has confidentiality agreements for information exchange, are included within the scope:
- Australia: TGA, Australian Register of Therapeutic Goods
- Canada: Health Canada, Medical Device Licence
- USA: FDA, 510(k) Clearance, Premarket Approval, 513(f)(2) “De Novo”
- Japan: Ministry of Health, Labour and Welfare, Pre-market approval
In recent months, MedTech Europe has actively participated in dialogues with both ANVISA and the European Commission (specifically DG SANTE) to advocate for the inclusion of MDR and IVDR devices within the scope of a particular policy. ANVISA has communicated that EU approvals may be incorporated following the conclusion of the extended transition periods outlined in the amendment to EU MDR and IVDR regulations. Recognizing this potential, as Europe progresses through its transition periods, MedTech Europe remains committed to pursuing opportunities to foster engagement and integrate the EU framework into Brazil’s reliance pathway.
The final text (in Portuguese) is available here.
