Resolution RDC 687/2022 was published on May 18th in the Federal Official Gazette. The new resolution provides for the criteria for granting or renewing the Brazilian Good Manufacturing Practices Certification for medical devices, and came into force on June 1st 2022, revoking RDC 183/2017.

RDC 687/2022 applies to risk class III and IV medical devices’ manufacturing units producing final products on their behalf or for other companies (including Software as a Medical Device – SaMD), or that carry out final releases of final products and that are involved in at least on stage of production other than design, distribution, sterilization, packaging or labeling stages.

Check the main changes when comparing to the previous resolution:

• Extends the scope of the resolution to all national and international establishments, no longer being restricted to establishments located outside of the national territory and Mercosur.

• Includes the mandatory certification for manufacturing units with packaging activities considered as a sterile barrier system for products declared as sterile, as well as manufacturing units of medical devices for in vitro diagnostics that perform the steps of impregnation, immunochromatography lamination or strip cutting.

• Updates the list of documents required for BGMP petition of granting and renewal processes.

• Accepts inspection reports issued by auditing bodies within the scope of a specific audit program recognized by ANVISA which were issued up to 3 years before the protocol date.

• Establishes that, in case of non-conformities listed in the audit report, an action plan must be forwarded to ANVISA and – if the non-conformity is still open – a request to comply with additional requirements will be issued.

• Certificates issued based on documentation analysis will not exempt the company from receiving on-site inspection by ANVISA, at any time. Refusal to receive the inspection or requests to change dates not accepted by ANVISA results in cancellation of the BGMP Certificate.

• Establishes a maximum period of 180 (one hundred and eighty) days for new manufacturing units within the scope of the new Resolution to apply a request for BGMP Certification.

Manufacturers must submit the following documents to request a BGMP Certificate:

To renew the BGMP Certificate, it is necessary to present the application Form as well as inspection and audit reports carried out. The other documents are necessary only in case it is necessary to update the information previously presented.

The resolution RDC 687/2022 also mentions the publication of the Risk Matrix used for risk analysis which subsidizes the granting of the BGMP Certificate through documentary evaluation, allowing greater understanding of the evaluation criteria. The Matrix disclosed considers the result of documents’ evaluation, the complexity of the manufacturing unit, the technologies involved and the intrinsic risk of the devices and indication of use, amongst others.

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DOMO Salute Team