ANVISA, Brazil’s medical device market regulator, has expanded quality management system certification requirements to additional types of manufacturing units for some higher-risk products.
According to ANVISA’s RDC 687/2022 (link in Portuguese), Brazilian Good Manufacturing Practice (BGMP) certification will be required for the following manufacturing units for Class III and Class IV devices:
- Manufacturing units producing final products either on their own behalf or for other companies
- Manufacturing units performing final releases of final products and that are involved in at least one stage of production other than design, distribution, sterilization, packaging or labeling stages
- Manufacturing units for software as a medical device (SaMD)…
