ANVISA -Brazilian Regulatory Authority – published the RDC 665/2022 (entered into force last 2May 2022). This resolution rewrites the BGMP (Brazilian Good Manufacturing Practices) requirements for Medical Devices and IVDs, becoming now the reference point for the adaptation of the Quality Management System of Manufacturers who place their devices on the Brazilian territory, both with and without adhering to MDSAP program.

RDC 665/2022 replaces the resolution RDC 16/2013 and the IN 08/2013.

What are the RDC 665/2022 requirements

Resolution RDC 665/2022 defines the Brazilian Quality Management System (QMS) requirements that must be followed regarding methods, controls and other processes related to the design, purchase and manufacture of Medical Devices and IVDs.

Among the most important are: the obligation to establish responsibilities, authorities and interrelation of all personnel managing and verifying the Quality Management System in the company; the necessity to establish the proof that the Suppliers have received the specifications for goods and supplied services; and the extension to the Importers of label and IFU control.

The BGMP introduced by resolution RDC 665/2022 apply to Manufacturers and Importers, as well as to distributors and retailers operating in Brazil. The entry into force of this resolution makes it necessary to adapt the Quality Management System of the MDSAP certified organization or of the company that simply exports the devices on the territory, to the updated requirements.

Does your company market Medical Devices in Brazil?

We remind you that if your organization is MDSAP certified for the Brazilian market or markets devices in Brazil, you will have to apply the BGMP RDC 665/2022 provisions and its regulatory requirements in order to be ready for next MDSAP or ANVISA inspection.

Choose Thema as your trusted partner for the adaptation of your Quality Management System to the BGMP requirements now in force and you will be able to market your devices quickly and in full compliance with the regulatory requirements.

Our Customer Service is at your complete disposal: contact us for further information!

Source:

RDC 665/2022, Agência Nacional de Vigilância Sanitária (ANVISA), 30 marzo 2022