ANVISA – Published on March 30th: RDC No. 665, which provides Good Manufacturing Practices for Medical Products and In Vitro Diagnostic Products.

The new RDC will come into force on May 2nd, 2022. The new RDC 665/2022 revoked RDC 16/2013 and incorporated IN 8 of 2013.

ANVISA published in the Official Gazette, on March 30, 2022, the COLLEGIATE BOARD RESOLUTION – RDC No. 665, which provides Good Manufacturing Practices for Medical Products and In Vitro Diagnostic Products. See more details below:

  1. The scope of the new RDC is now expanded and mentions manufacturers, distributors, storers and importers of medical devices and in vitro diagnostic products that are commercialized in Brazil;
  2. There were changes in the structure of the standard (chapters, articles) as well as minor text adjustments;
  3. The management representative remains mandatory, being more explicit;
  4. It is now an explicit requirement to establish the responsibility, authority and interrelationship of all personnel who manage, perform and verify quality-related work;
  5. RDC 665 details the Risk Management requirements, however there is no difference to what is already expected to be implemented;
  6. Continuous Risk Management Process, RDC 665 clarifies that the points of continuous analysis of the GER, which is already established by ISO14971:2019
  7. The design requirements remain, they were just reorganized;
  8. Evidence that suppliers have received specifications for materials and services is now required for each purchase.
  9. Article 70 mentions that all personnel who are in contact with the product or its environment must be clean, healthy and properly dressed. This also includes people outside the organization as service providers.
  10. Inspection of labels and instructions for use must be documented in the product’s historical record. This requirement is now applicable to importers.
  11. It was made clear that all documents must be available whenever requested by health surveillance agencies.
  • Stay Tuned: authorization letters that mentioned RDC 16/2013 must be changed to the new RDC665/2022
  • References, including chapters and structures, to RDC 16/2013 in quality documents must be changed as well.

Link to access RDC 665/2022 in english, click here.

For more information and explanations about it, send us an e-mail: [email protected]

Passarini Group

Published: 04/14/2022

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