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—— South America ——

Brazil ANATEL for Wireless Medical Devices

Previously, ANATEL certification was required for commercialization but not registration.ANVISA recently published Technical Note 2/2018 requiring ANATEL certification as a component of registration and modification applications for devices used for telecommunication as well as for devices using radio frequency (RF) or wireless technology. So Brazilian market applicants must include ANATEL certification in their ANVISA registration applications; registrants may no longer wait to begin ANATEL certification until after they submit their registrations to ANVISA.
CINRIO: CINRIO Certification Consulting Co., Ltd.