Sell class III, class IV
or IVD medical devices
in Brazil
Discover the Brazil GMP Quality System Compliance service.
Fill out the form and wait contact a consultant.
Sell class III, class IV or IVD medical devices in Brazil
Discover the Brazil GMP Quality System Compliance service.
To be legally marketed, any health product needs to be registered with ANVISA.
Brazilian importers and distributors wishing to sell class III or class IV medical devices in Brazil must have their manufacturers certified by ANVISA (GMP). The requirements for medical devices are specified in the Brazilian resolution RDC 665/2022 or in the MDSAP model.
How is the process carried out?
In order to comply with Brazilian requirements, it is necessary to submit a GMP Certificate to start Class III or IV registration. GMP certification requires an ANVISA inspection (on-site inspection) or evaluation of the audit report in accordance with the regulatory convergence agreement (IMDRF – MDSAP). ANVISA will only approve device registrations after successful completion of a good manufacturing practice (GMP) certification.
B-GMP inspection requests for foreign manufacturers must be submitted by their Brazilian Registration Holder (BRH), who will be the holder of the certificate issued by ANVISA.
To be legally marketed, any health product needs to be registered with ANVISA.
Brazilian importers and distributors wishing to sell class III or class IV medical devices in Brazil must have their manufacturers certified by ANVISA (GMP). The requirements for medical devices are specified in the Brazilian resolution RDC 665/2022 or in the MDSAP model.
How is the process carried out?
In order to comply with Brazilian requirements, it is necessary to submit a GMP Certificate to start Class III or IV registration. GMP certification requires an ANVISA inspection (on-site inspection) or evaluation of the audit report in accordance with the regulatory convergence agreement (IMDRF – MDSAP). ANVISA will only approve device registrations after successful completion of a good manufacturing practice (GMP) certification. B-GMP inspection requests for foreign manufacturers must be submitted by their Brazilian Registration Holder (BRH), who will be the holder of the certificate issued by ANVISA.
QR Consulting helps your company to ensure that its suppliers of risk class III and IV products meet ANVISA requirements:
Thorough evaluation of your supplier's QMS through an internal audit to ensure complete compliance with the requirements of Brazilian regulations;
Adaptation of the QMS if necessary, suggesting corrective actions;
Support for your international manufacturer during the ANVISA GMP certification inspection.
Meet some of our partners and customers:
A structure dedicated to the development of your business.
A structure dedicated to the development of your business.
Fill out the form and wait contact a consultant.
