Brazil to initiate electronic submission procedure for approval of medical devices

Brazil’s medical devices regulatory agency ANVISA has announced the initiation of registration and approval of medical devices through electronic submission of documents by manufacturers. The new scheme from ANVISA would allow the Brazilian medical devices market registrants to arrange and submit their applications faster and at a low cost. Presently, applicants have to print all submission documents to present to ANVISA. Once the new plan is implemented, there would be a transition period of one year, during which registrants would need to submit their applications electronically as well as the printed version. After the completion of transition period, ANVISA will accept submissions only via electronic media, including CDs and DVDs as well as e-CNPL certificates. ANVISA plans to publish additional details and guidance on its electronic submission process at some point over the transition period.

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