Apr 12, 2022

ANVISA, Brazil’s medical device market regulator, has issued a new resolution updating Brazilian Good Manufacturing Practices (BGMP) for devices as well as in vitro diagnostic (IVD) products.

ANVISA’s RDC 665/2022 (link in Portuguese) replaces previous regulations including RDC 16/2013 and IN 08/2013, and comes into effect on May 2, 2022.

The new BGMP requirements will apply to medical device and IVD manufacturers, plus distributors, retailers and importers doing business in Brazil. RDC 665/2022 covers BGMP quality management system requirements for methods, controls and other processes related to the design, purchase and manufacture of devices and IVDs; the updated BGMP requirements also address device packaging, labeling, storage, distribution, installation and technical assistance related to device manufacturing.

Emergo by UL consultants in Brazil will provide additional analysis on BGMP compliance changes in the coming weeks.

Learn more about Brazilian medical device and IVD regulations at Emergo by UL:

 

Author

  • Stewart Eisenhart

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