Registration and Approval with ANVISA for Medical Products in Brazil
Medical products in Brazil are regulated by the National Sanitary Surveillance Agency (ANVISA). The regulations in Brazil as well as the classification schemes for medical products are similar to those found in the European MDD 93/42 / ECC directive. The first step in the process of registering a medical product in Brazil is to determine the classification of this device. This is key to ensuring a smooth registration process. Once the classification is confirmed, our team of Brazilian consultants can begin the registration process with ANVISA.
Let us help you register your medical product with ANVISA
After confirming the classification of your product, we began the process of preparation of your technical report required for registration with ANVISA. The Brazilian technical report shall contain information on the device in accordance with Annex III Part A, B or C of RDC 185/01. The registration dossier differs from the European Technical Report and the US FDA 510 (k) license. However, if you already have the CE Marking or the release of the US FDA 510 (k) for your device, the information contained in these files will satisfy most of the requirements for registration of ANVISA in Brazil.
If your medical device is powered by electricity, you will probably have to obtain INMETRO certification from an authorized testing laboratory in Brazil. As of May 2010, ANVISA also requires manufacturers of medical products to comply with the Registration Holder in Brazil.
Duration of the medical device registration process in Brazil
According to our experience, the process to obtain the approval of a Class I, II or III medical device by ANVISA varies from 12 to 24 months. This period includes the preparation of your technical registration report for ANVISA and translations of the associated documents, if necessary.