Do you know what do you need to sell dental implants in Brazil? In this content we will explain essential points for your process to be successful.
Selling dental implants in Brazil is not so simple! There are several rules and precautions to be taken for each action in relation to the product.
To sell dental implants in Brazil it is necessary to go through some regulatory steps with Anvisa - National Health Surveillance Agency.
To sell dental implants in Brazil, there are two options to be followed: 1st to establish a physical company in Brazil – to regularize company and products. 2nd Use of Holder services: Your company can bring your products through Stone Okamont, which already has the necessary authorizations, being only required to register the product with Anvisa to sell dental implants in Brazil.
Steps to establish a physical company in Brazil:
1st: Choice of location.
2nd: Obtaining your operating license. This is done with VISA - Sanitary Vigilance of the municipality where your company was established. At this stage, it is necessary to adapt the company's physical structure in order to receive Visa's inspection, once the inspection was carried out without any non-conformity, the Operating License will be issued. However, in view of a non-conformities, it will be necessary to comply with VISA requirements within the established period to receive a new inspection. Click: Operating License.
3rd: it consists of reaching your Operating Permits. Unlike the previous process, this is done directly by Anvisa - National Health Surveillance Agency, so the petition is protocoled in Brasília, where the whole process will take place.
In this phase, a compilation is made with all the necessary documents and collection of fees. Click> Operation Permits.
Anvisa, as well as the FDA and other regulatory agencies, separate products into risk classes. The risk classfication at Anvisa range from 1 to 4. 1 being the lowest and 4 the highest.
The dental implant fits into a correlated risk class 3, making it mandatory to obtain the Certificate of Good Manufacturing Practice in order to be able to sell dental implants in Brazil. CBPF is a certificate required by Anvisa for products with a risk class between 3 and 4.
This certificate covers all processes that involve the product; from the production, packaging, storage, distribution and also several questions about the structure of the company such as production flowchart, hierarchical and others. All content must be very well detailed. Click> Certification of Good Manufacturing Practices.
After the regularization of the company, it is finally possible to start product registration to be able to sell dental implants in Brazil! For this it will be necessary to gather a series of information, such as: instructions for use, reports, tests, among others. Click> Product Registration.
It is very important to register before starting to sell dental implants in Brazil, as unregistered products may be seized by Anvisa, since they are not in accordance with Brazilian law. Stone Okamont can help you with the entire process needed to sell dental implants in Brazil.
Fill out the form below, talk to one of our professionals and ask all your questions about how to sell dental implants in Brazil.
Editor: Gabriela Batman Carvalho