Brazil

1. Authorities

The Brazilian National Health Surveillance Agency is the National Health Surveillance Agency (ANVISA).

2. Relevant Regulations

According to ANVISA's classification, the regulatory regulations for MD are RDC_751_2022, and the regulatory regulations for IVD are RDC_36_2015.

3. Time estimation

For Class I products, ANVISA will assign a Notification number based on the materials required by ANVISA and submit them to BRH. There is no need to review the technical documents. However, ANVISA will also cancel the registration number based on the actual product situation. If the materials are not prepared in accordance with the basic requirements, post-market tracking or the wrong product category is used, BGMP is not required for Class I and Class II products, and the average time is 3-4 months.

For Class II, III and IV products, ANVISA will need to review the registration application. Once the evaluation is passed, NVISA will publish the registration number on DOU = Diário Oficial da União. Since Class III and Class IV require BGMP, they can be converted if there is MDSAP. The application review period is 4-6 months, and it may be as long as 8-12 months without MDSAP.

4. Local Representatives

For all categories of medical products, foreign medical device manufacturers without physical offices in Brazil must appoint a Brazil Registration Holder. The Brazil Registration Holder acts as a liaison between the manufacturer and the Brazilian National Health Surveillance Agency ANVISA, and is responsible for the manufacturer's medical device registration and post-marketing supervision in Brazil. As long as medical devices are sold in Brazil, there must be a Brazil Registration Holder, which we can also call a local representative in Brazil, because choosing a suitable institution and organization as the Brazil Registration Holder is very critical. Brazil's BRH has the following important responsibilities and functions:

1. The Brazilian registration information holder controls the company's product registration and BGMP certificate. Once a Brazilian registration information holder is assigned to a medical device, it will be difficult to replace it without the cooperation of the original Brazilian registration information holder. It is particularly important to select a person who is not involved in product sales as an independent third-party Brazilian registration information holder. If we are unhappy with the cooperation with a distributor, we can replace other distributors at any time without considering changing the product registration certificate and BGMP certificate.

2. During the registration process, it is necessary to provide product and enterprise information to the Brazilian registration information holder, which involves a large amount of confidential design and test results. Manufacturers choosing an independent and professional third-party Brazilian registration information holder is conducive to protecting their confidential information.

3. Independent and professional third-party Brazilian registration information holders mainly provide professional services on how to achieve better compliance and post-market supervision. They can more closely monitor the Brazilian authority ANVISA’s changes and updates on medical device regulations and various information that the authorities need to pay attention to, so as to respond to changes in a timely manner.

4. Once a recall or adverse event occurs, an independent third party can report these situations to the manufacturer more objectively, rather than conflicting with the interests of the distributor.

5. Successful Cases

5+ Successful Cases