Anvisa certification enables the production and sales of health care products to meet the requirements of laws and regulations, so as to promote and protect the health of the people. Anvisa certification implements the registration management and recognition system for medical device products, and maintains relevant databases.

All medical devices imported to Brazil or distributed in Brazil must be registered with Anvisa certification. Anvisa has formulated different application processes and requirements for different types of medical devices.

For non local manufacturers in Brazil, the basic steps and processes of applying for Anvisa certification are summarized as follows:

(1) First, determine the category of the product;

(2) The designated Brazilian registered holder (BrH), which must obtain the license of Anvisa certification;

(3) Authorize the BrH to apply for Anvisa certification registration and submit relevant documents on its behalf, as well as BGMP audit application on its behalf;

(4) The product has obtained Inmetro certification; The products must pass the testing of ILAC member laboratories that meet the requirements of Brazilian standards, and obtain the Inmetro certificate issued by Inmetro authorized institutions (for example, Intertek Intertek group is the member laboratories of ILAC and Inmetro authorized issuing institutions). The certificate is valid for 5 years, and the validity of the certificate is maintained through factory inspection every year.

(5) Apply for GMP certificate for class I or class II products. Intertek is qualified to issue GMP certificates; Sichuan or IV products apply for Brazil Anvisa certification BGMP audit, and obtain BGMP certificate after passing the audit;

(6) For class I or class II low-risk products, carry out a simple registration process, and provide product technical data to BrH for filing, so as to deal with the possible random audit of Anvisa certification; For other products, submit the documents mentioned above to BrH for a complete registration process. For all categories of products, BrH will submit all the above materials to Anvisa certification for review after paying relevant fees to Anvisa certification;

(7) Brazil Anvisa will publish a registration number on Diario Oficial Da Uniao (Dou), which is valid for 5 years after the approval of the relevant application materials.