Brazilian Medical Device - Anvisa Registration in Brazil

Amaral & Cia Consulting helps medical device manufacturers obtain regulatory approval from Agência Nacional de Vigilância Sanitária (ANVISA). We assist clients with ANVISA Medical Devices Regulations issues related to quality assurance, regulatory compliance and distribution management. Our consultants are also experienced in quality system audits and implementation and can help your company meet ANVISA regulations.

Foreign medical device manufacturers who do not have a physical location in Brazil must appoint a Brazilian Registration Holder (BRH). This company will act as a liaison between your company and Brazil’s National Health Surveillance Agency (ANVISA) and is responsible for your medical device registration in Brazil. Amaral & Cia Consulting is certified to act as a Brazilian Registration Holder.

ANVISA registration in Brazil

The base regulations in Brazil and medical device classification schemes are similar to those found in the European MDD 93/42/EEC. The first step in the process of registering a medical device in Brazil is to determine the classification of the device. Medical devices are divided into 4 groups (Classes I-IV). To see the ANVISA medical device process click here.

After confirming the product classification, the process of preparing the technical file needed for registration will begin. The Brazilian technical file must contain information on the device in accordance with Annex III Part A, B or C of RDC 185/01. The registration file differs from a European Technical File and US FDA 510(k) application. However, if you already have CE Marking or US FDA 510(k) clearance for your device, the information contained in those files will satisfy most of the requirements for the ANVISA registration. One thing to keep in mind is that all documents must be translated into Portuguese, including the Instructions for Use.

Electrically powered medical devices will likely need INMETRO certification from an authorized testing lab in Brazil. Also, starting in May 2010, ANVISA requires some medical device manufacturers to comply with Brazilian GMP. Amaral & Cia Consulting can assist you with INMETRO testing coordination, modifications to your existing FDA GMP and/or ISO 13485 compliant quality system and act as your Brazilian Registration Holder.

Services we provide:

• Brazilian Registration Holder

• Process Device Listing

• Device Classification

• Process Technical Files

Please contact us for more information on all of our Brazil consulting services...