ANVISA Granted More Leverage to Prioritize Medical Device-Related Health Risks

A new Brazilian law allows ANVISA, the country’s medical device market regulator, greater latitude to manage public health risks and surveillance measures in a way that may also boost efficiencies for Brazilian market registrants.

Brazil ANVISA law changes medical device approvalChapter X of the new Law 13,097/2015 (link in Portuguese) includes the following changes to the existing ANVISA regulatory process:

  • Validity timeframes for some devices may be increased to up to 10 years depending on product characteristics and risks
  • ANVISA may accept quality management system inspection reports issued by regulators in other countries or by certified inspection or auditing organizations outside of Brazil
  • ANVISA may expand certifications of laboratories authorized to conduct health surveillance inspections and post-market surveillance
  • Updated requirements for registration transfers, operating permit renewal exemptions

Although the new law has already been published, ANVISA will need to release regulations that further define and implement the allowances made in the law.

To learn more about medical device registration and approval requirements in Brazil, view our Brazil Medical Device Registration Overview video.

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