ANVISA certification promotes and protects people’ health through ensuring that the production and distribution of medical products conform to laws and regulations.
ANVISA adopts the registration and certification system for medical devices and maintains relevant databases.
All medical devices imported to or distributed in Brazil must be certified and registered with ANVISA.
ANVISA certification has different application processes and requirements for different types of medical devices.
Basic steps and processes of ANVISA certification of non-Brazil manufacturers are summarized below:
(1) Determine the product category;
(2) Appoint a Brazil Registration Holder (BRH). This BRH must be permitted by the ANVISA certification;
(3) Authorize this BRH to apply for ANVISA certification and registration, submit relevant files and apply for BGMP audit;
(4) The product obtains the INMETRO certification; The product must pass the specified tests conducted by an ILAC member laboratory and obtain the INMETRO certificate issued by an INMETRO authorized authority (e.g., Intertek is an ILAC member laboratory and an INMETRO authorized authority).
The validity of the certificate is 5 years. Factory inspection shall be conducted each year to maintain the certificate validity.
(5) Class I or II products apply for GMP certificate.
Intertek is qualified to issue GMP certificates. Class III or IV products apply for Brazil ANVISA certification and BGMP audit. Those passing the audit are given BGMP certificates.
(6) Class I or Class II products with low risks are subject to the simple registration process. Technical files shall be provided to the BRH in case of any possible random audit of ANVISA certification; For other types of products, the files mentioned above shall be provided to BRH to go through the complete registration process.
For all types of products, BRH shall firstly pay ANVISA relevant fees and then submit all above files to ANVISA for audit;
(7) ANVISA will review relevant application materials and publish a registration number on Diario Oficial da Uniao (DOU) for qualified applicant. The registration validity is 5 years.
In addition, submitting the following materials helps to obtain the ANVISA certification:
(1) The medical device’s registration certificate obtained in the country of origin;
(2) If the medical device is not registered in the country of origin, please explain the reason and submit more than two registration certificates obtained in other countries.
The ANVISA registration is valid for 5 years. If the product is changed during this period, the importer shall submit all original registration documents and new documents after change to the ANVISA for review.
One year before the expiration date, the importer can prepare the extension application. If the extension is approved, the new validity is still 5 years.
The importer is also entitled to terminate the registration at any time.