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ANVISA – RDC No. 687 provides the criteria for granting or renewing the Certification of Good Manufacturing Practices for Medical Devices

Published on May 13th: RDC No. 687 provides the criteria for granting or renewing the Certification of Good Manufacturing Practices for Medical Devices.

The new legislation will get into force on June 1st, 2022. The new RDC 687/2022 revoques RDC 183/2017.

  • Certification continues to be mandatory for manufacturers of class III and IV medical devices that produces final products on their behalf or for another company;
  • The scope of the new RDC applies now for the activity of sterile barrier’s packing system for products declared as sterile. This is now considered a requirement for Certification of Good Manufacturing Practices (Brazil). It will also be required for IVD manufacturing sites that perform the steps of impregnation, lamination or cutting of immunochromatography strips;
  • The structure of the standard were changed (chapters, articles and order);
  • New definitions have been added and the list of documents for the petition has been changed as well;
  • A period of 180 days was established for companies that need to make the necessary adequation and protocols.

NOTE: The deadline for renewal remains as established in RDC 497/2021

Link to access RDC 687/2022 in portuguese, click here.

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

Passarini Group

Published: 05/31/2022

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