May 27, 2022

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)

Affected manufacturers have until November 28, 2022 to come into compliance with ANVISA BGMP certification requirements.

Required documents for BGMP certification

Manufacturers impacted by RDC 687/2022 will be required to provide documentation listed below as part of their initial requests for BGMP certification:

  • Completed application form for BGMP certification
  • General device production flowchart that highlight which steps in the process involve the manufacturing unit applying for BGMP certification
  • Layouts of facilities of manufacturing unit applying for certification
  • Lists of all devices falling under ANVISA oversight that are produced by BGMP certification applicant, plus details of such devices including technical name and risk classification
  • Statements as to whether devices produced by BGMP applicant are registered in their countries of origin, as well as whether countries of origin participate in the MERCOSUR South American trade bloc or in the International Medical Device Regulators Forum (IMDRF)
  • Details regarding any inspections or audits occurring within the previous three years at the certification applicant’s facilities
  • Copies of inspection or audit reports to support compliance with good manufacturing practices in applicant’s country of origin
  • Copies of inspection reports from medical device regulators participating in quality system audit programs such as the Medical Device Single Audit Program (MDSAP) officially recognized by ANVISA

When it comes time to renew BGMP certification, manufacturing units will need to provide new certification application forms as well as updated inspection and audit reports from home-country regulators. Any updates to manufacturing units’ layouts, production workflows or devices under ANVISA oversight should also be provided during BGMP certification renewal processes.

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

 

Author

  • Stewart Eisenhart

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