Brazilian INMETRO Medical Device Certification Consulting

For manufacturers of certain medical devices seeking to sell their products in Brazil, electrical safety testing and certification from The National Institute of Metrology, Standardization and Industrial Quality (INMETRO) may be required in order to obtain National Health Surveillance Agency (ANVISA) registration. Although we do not perform INMETRO testing, Emergo Group can assist you with INMETRO certification by coordinating testing on your behalf as part of your medical device registration in Brazil.

As part of our INMETRO certification consulting service, we can identify INMETRO-accredited testing agencies that can certify your medical device and obtain quotes on your behalf, ensuring your registration proceeds smoothly. However, most companies located outside Brazil have already completed electrical safety testing and have certifications in place. (Testing must have been performed within the previous two years.)

As an INMETRO consulting service provider, Emergo Group can oversee your testing process and act as your primary point of contact with testing facilities in Brazil to ensure a smoother certification process. INMETRO typically recognizes previously completed certifications, and also accepts electrical safety certifications from foreign testing agencies if performed by International Laboratory Accreditation Cooperation (ILAC)-certified laboratories. Your testing results will still need to be validated by INMETRO in order to obtain certification.

ANVISA lists specific electronic medical devices requiring both INMETRO certification and Brazil Good Manufacturing Practice (BGMP) registration. INMETRO-certified Class I and II devices not on this list do not require BGMP registration. This means that for these INMETRO-certified devices, manufacturers do not have to pay BGMP inspection fees every two years. (Please note, all Class III and IV medical devices as well as Class II, III, and IIIa IVDs are still subject to the BGMP inspection.)