Sell class III, class IV or IVDS medical devices in Brazil
Know Brazil GMP Quality System Compliance service.
Fill the form and wait
for a consulting pro.
Sell class III, class IV or IVDS medical devices in Brazil
Know Brazil GMP Quality System Compliance service.
Brazilian market
Foreign companies wishing to sell their class III or class IV medical devices in Brazil must be certified by ANVISA (GMP). The requirements for medical devices are present in the Brazilian resolution RDC 16/2013 and in the MDSAP model.
Brazilian market
Foreign companies wishing to sell their class III or class IV medical devices in Brazil must be certified by ANVISA (GMP). The requirements for medical devices are present in the Brazilian resolution RDC 16/2013 and in the MDSAP model.
How is the process done?
In order to comply with Brazilian requirements, it is necessary to submit a GMP Certificate to initiate Class III or IV registration. GMP certification requires an inspection by ANVISA (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.
Applications for B-GMP inspection for foreign manufacturers must be submitted by their Brazilian Registration Holder (BRH), who will be the holder of the certificate issued by ANVISA.
How is the process done?
In order to comply with Brazilian requirements, it is necessary to submit a GMP Certificate to initiate Class III or IV registration. GMP certification requires an inspection by ANVISA (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.
Applications for B-GMP inspection 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 meet
Brazilian QMS requirements through actions such as:
Thorough Gap Assessment to assess your current level of compliance with requirements, performing an on-site audit in preparation for your B-GMP inspection;
Modification of existing
QMS to comply with Brazilian
GMP requirements;
On-site support
during ANVISA's inspection of
your quality system.
QR Consulting helps your company meet Brazilian QMS requirements through actions such as:
Thorough Gap Assessment to assess your current level of compliance with requirements, performing an on-site audit in preparation for your B-GMP inspection;
Modification of existing
QMS to comply
with Brazilian
GMP requirements;
On-site support during ANVISA's
inspection of
your quality system.
Check some of our clients:
Check some of our clients:
