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The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
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This updated edition is a great reference for anyone working in multinational product development and marketing.
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Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Posted 28 August 2014 | By Louise Zornoza,
This content is provided by RegLink News, publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members.
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.
Tags: Brazil, RPS, eSubmission
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