ANVISA Medical Device Registration and Approval in Brazil

Medical devices in Brazil are regulated by the Agência Nacional de Vigilância Sanitária (ANVISA). The regulations in Brazil, as well as the 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, of course, to determine the classification of the device. This is critical for ensuring a smooth registration process. Once this has been confirmed, our team in Brazil can begin the ANVISA registration process.

Let Emergo's team in Brazil help register your medical device with ANVISA

After confirming your product classification, we begin the process of preparing your technical file needed for registration with ANVISA. 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 dossier 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 in Brazil. One thing to keep in mind is that all documents must be translated into Portuguese, including your Instructions for Use. Our office in Brazil can assist you with document translation if needed.

If your medical device is electrically powered, you will likely need to obtain INMETRO certification from an authorized testing lab in Brazil. Also, starting in May 2010, ANVISA requires most medical device manufacturers to comply with Brazil Good Manufacturing Practice (GMP).  We can assist you with INMETRO testing coordination, modifications to your existing FDA GMP or ISO 13485 compliant quality system and act as your Brazilian Registration Holder.

Duration of the medical device registration process in Brazil

In our experience, the process of getting a Class I, II or III medical device approved by ANVISA ranges from 6-12 months. This timeline includes the preparation of your ANVISA registration technical file and associated document translations, if needed. We charge a flat-fee per device family for preparing an ANVISA registration and the price depends on the classification of your medical device. ANVISA also charges a registration fee which currently ranges from 300-28000 BRL. The registration fee is due to ANVISA when the technical file is submitted and the amount depends on the annual revenue of the company submitting the registration. Registration certificates are valid for five years.     

There are additional steps in the process of obtaining medical device approval from ANVISA in Brazil. You can download a free PDF chart that outlines all steps of the Brazil medical device registration process.

Please contact us for more information or a free proposal on registering your medical device with ANVISA in Brazil.