Completing the process of reviewing and consolidating normative acts that allowed improvements in the wording and form of normative acts and the exclusion of obsolete provisions, ANVISA published on March 30th 2022, in the Brazilian Official Gazette (D.O.U., in Portuguese), RDC No. 665/2022, which provides for Good Manufacturing Practices (GMPs) for Medical Devices and In Vitro Diagnostic Products (IVDs). The new RDC comes into effect on May 2nd 2022.

The Brazilian Good Manufacturing Practices (BGMP) requirements apply to manufacturers of medical devices and in vitro Diagnostic Products, as well as distributors, storers and importers of products that are marketed in Brazil. RDC No. 665/2022 establishes the requirements that describe the Good Manufacturing Practices for methods, controls and other processes related to the design, purchase, and manufacture of devices and IVDs. The updated BGMP requirements also address the packaging, labeling, storage, distribution, installation and service processes applicable to medical devices and IVDs.

In the process of updating the standard which deals with Good Manufacturing Practices, RDC No. 665/2022 revokes RDC No. 16/2013 and incorporates and revokes IN No. 8/2013. The update of the normative act does not, however, represent changes in merit compared to the norms that were revoked. Nevertheless, authorization letters and QMS documents must be updated with reference to current regulations.

Follow us on social media to get an update on the top news regarding the Brazilian regulatory system.

DOMO Salute Team