Brazil medical device QA/RA blog

News and commentary on regulatory changes.

Changes to Brazil ANATEL Certification Requirements for Wireless Medical Devices

EMERGO SUMMARY OF KEY POINTS:

  • ANATEL certification for wireless medical devices is now required for ANVISA registration in Brazil.
  • Previously, ANATEL certification was required for commercialization but not registration.
  • Manufacturers that have already started their ANVISA registration projects will need to secure ANATEL certification before submitting registration applications.

Brazil ANATEL certification rule change for wireless medical devicesBrazilian medical device regulators have updated registration requirements for products that feature Bluetooth, wireless and related functionality.

ANVISA recently published Technical Note 2/2018 (link in Portuguese) 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.

ANATEL certification: What’s changed?

Previously, ANVISA required ANATEL certification for appropriate devices only before actual commercialization in Brazil, and manufacturers were not required to provide such certification to the agency.

Following Technical Note 2/2018, 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.

According to Emergo consultants in Brazil, the new requirements do not affect only new market registrants. Companies that have already begun their ANVISA registration projects will also have to provide ANATEL certification to the regulator before their applications can be approved.

Additional Brazilian medical device regulatory resources:

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