ANVISA

ANVISA certification promotes and protects the health of the people through the control of the production and sales of health and medical products to make them comply with the requirements of laws and regulations. ANVISA certification implements a registration management and accreditation system for medical device products, and maintains related databases.

All medical devices imported into Brazil or distributed in Brazil must be registered with ANVISA certification. For different types of medical devices, ANVISA certification has developed different application procedures and requirements.

For Brazilian non-local manufacturers, the basic steps and procedures for applying for ANVISA certification are summarized as follows:

(1) First determine the category of the product;

(2) Designate the Brazilian registration holder (BRH), the BRH must be approved by ANVISA;

(3) Authorize to the BRH, allow its agent to apply for ANVISA certification registration and submit relevant documents, and to act as an agent for BGMP audit applications;

(4) The product has obtained INMETRO certification; the product must pass the testing of ILAC member laboratories that meets the requirements of Brazilian standards, and obtain the INMETRO certificate issued by the INMETRO authorized agency (for example, Intertek Tianxiang Group is the ILAC member laboratory and the INMETRO authorized issuing agency) . 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 has the qualification to issue GMP certificates; Sichuan products or Iv products apply for Brazil ANVISA certification BGMP audit, and pass the audit to obtain the BGMP certificate;

(6) For low-risk products in Class I or Class II, perform a simple registration process and provide product technical information to BRH for storage and filing in order to cope with the possible random audit of ANVISA certification; for other types of products, submit the above mentioned in this article The documents mentioned above are sent to BRH for a complete registration process. For all types of products, after BRH pays relevant fees to ANVISA certification, submit all the above materials to ANVISA certification for review;

(7) Brazil ANVISA certification review related application materials, after passing, a registration number will be published on Diario Oficial da Uniao (DOU), and the registration is valid for 5 years.