capas regulatory affairs - rdc 687-22

RDC 687/22

The new RDC 687 came into force in May 2022, which provides for the criteria for granting or renewing the Certification of Good Manufacturing Practices for Medical Devices, complementing the general provisions of administrative procedures for granting the Certification of Good Manufacturing Practices.

According to the Federal Official Gazette, RDC 687/22, which revokes RDC 183/17, simplifies the documentation presented in the certification of good manufacturing practices in order to reduce the amount of technical requirements drawn up during the analyses, ensuring greater agility to the process.

This RDC encompasses risk classes III and IV manufacturing units in cases where there are:

final product production on your behalf or for another company.

carrying out the final release of the final product, associated with at least one production step, except the design, distribution, sterilization, packaging and labeling steps. In this case, the packaging activity considered as a sterile barrier system for products declared as sterile and the manufacturing units of medical devices for In Vitro diagnostics that perform the steps of impregnation, lamination or cutting of immunochromatography strips are also subject to certification of good manufacturing practices.

medical software (Software as a Medical Device - SaMD) as the manufacturing unit.

You who are an entrepreneur in the health market and work with the manufacture of medical devices, whether physical products or software, and want your certification of Good Manufacturing Practices, count on our team of experts!

Contact us!

-> regulatory@enzytec.com

-> +55 31 99145-9259


Any questions? Contact us and you will be answered soon!