Brazilian Device Industry Prepares for eSubmissions

Regulatory NewsRegulatory News | 28 August 2014 |  By 

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Brazil's medical device industry should prepare for electronic submissions, Anvisa, Brazil's national regulatory agency, said at a 20 August 2014 meeting.

The meeting provided an opportunity for the agency to discuss its implementation strategy for the International Medical Device Regulator Forum’s (IMDRF) Regulated Product Submission (RPS) protocol. The protocol is a harmonized electronic submission format for the registration of medical devices, being developed by the countries that make up the IMDRF (Australia, Canada, China, the European Union, Japan, Russia, the US and others).

The first step in that process is the Marketing Authorization - Table of Contents (ToC-MA) that defines the new format of the electronic technical dossier.


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