The Anvisa Product Registration is one of the most important steps when talking about the Brazilian market.
Product registration at Anvisa is the last stage of regularization and is where the product will be tested to ensure product safety and efficiency. It is important to stress that for a product to be Registered at Anvisa, it needs to meet all the criteria established by law by the National Health Surveillance Agency (Anvisa).
ANVISA divides the products that are regulated by it into risk classes ranging from I to IV. Normally, products in class I are not registered, but rather notified, or registered, or exempted. The other classes, on the other hand, need to regulate their products with the autarchy.
Regulation and Registration
To start the process of Regulation and Registration of Products Anvisa, it is necessary to have the License of Operation of the Local Health Surveillance and the Authorization for the Operation of a Company (AFE).
GRP Brazil takes care of the process of Regulation and Registration of Products Anvisa as well as provides advisory and consulting services for obtaining the license and authorization of the company, further facilitating the regulatory processes with the Agency.
Do you need support with Product Regulation Work at ANVISA?
GRP-Brazil Can Support, Contact Us Today!
GRP Brazil Office provides Regulatory Affairs, Quality, Clinical and Safety services to pharmaceutical, medical device, and life-consumers companies worldwide to register them product with ANVISA the local Health Authority (HA).
About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, and Mexico. GRP helps many life science companies register their products in different countries in compliance with local regulations.