ANVISA Medical Device Importation Process Moves to All Electronic

Brazil’s ANVISA has switched over to a wholly electronic submission system for importation of devices.

Effective May 31, all applications will need to be submitted thru ViCOMEX, a streamlined platform that provides step-by-step guidance.

Foreign manufacturers and importers must first register the licensed importer on Brazil’s Siscomex, foreign trade portal. The new directive RDC 76/2016, can be found here (in Portuguese): www.fdanews.com/06-08-16-ANIVSADirective.pdf. — Joya Patel