By Stewart Eisenhart, Emergo Group
Brazilian medical device market regulator ANVISA now accepts only electronic submissions of petitions for importation of devices.
According to a new directive, RDC 76/2016 (link in Portuguese), ANVISA’s device importation process has moved to a wholly electronic system known as ViCOMEX as of May 31, 2016. The ViCOMEX system was designed to provide a single platform through which medical device importers can submit all necessary documentation and avoid any delays more common with manual petition processes.
Foreign manufacturers and importers must now follow the following process:
- Freight forwarder must register the licensed importer on Brazil’s Siscomex foreign trade portal.
- All documents required for petition for importation should be compiled in a single dossier linked to the licensed importer.
- An email link is then sent to the importer with instructions on how to electronically pay submission fees.
- Once fee payment is confirmed, ViCOMEX sends an email receipt to the importer, and the system creates an importation process that is sent to ANVISA so that analysis of the import petition can begin.
Related information on Brazilian medical device market entry can be found on ourANVISA registration and distributor qualification service pages, as well as on our Brazil regulatory process chart and device approval video overview.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.
The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.
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