Before medical device manufacturers can legally sell their products in Brazil, they must comply with Brazilian medical device regulations set forth by the Agência Nacional de Vigilância Sanitária (ANVISA).
The approval process in Brazil can take a very long time, so it is best that you know the correct classification and grouping of your medical device prior to starting the ANVISA registration process. Improper classification or grouping into product families, slight changes to formulations, or claims of performance which cannot be substantiated by clinical data can have a staggering impact on the regulatory approval process and its associated costs.
Determining Your ANVISA Device Classification and Grouping
In the ANVISA regulatory process, the first step in determining your path to compliance with Brazilian regulations is to ascertain the classification of your medical device. Medical devices in Brazil are classified as class I, II, III and IV using a set of 18 rules found in Annex II of Brazilian RDC 185/01 published by ANVISA. Devices are classified according to these categories:
- Non-invasive medical products
- Invasive medical products
- Active medical products
- Special Rules (including contraceptive, disinfectant, and radiological diagnostic medical products)
In addition to determining the classification of your device, we will also determine the grouping into product families for submission, which will determine the number of submissions required to ANVISA.
Depending on the class of your device, the registration approval process in Brazil can take anywhere from 5-10 months to 4+ years. Once devices are classified and grouped, manufacturers must follow the Cadastro or Registro registration route.
Why choose Emergo to assist with medical device classification?
Emergo represents hundreds of medical device and IVD companies in Brazil. Our Brazil team specializes in medical device registration and can help you determine the proper ANVISA classification for your medical device.
- We will confirm whether your product is a medical device, cosmetic, medicinal or combination product.
- We will determine whether any local certification requirements apply to your device, such as ANATEL or INMETRO certification
- We will review your technical information and intended use, and claims for your device, ensuring proper classification and grouping before beginning the registration process.
- Our Brazil team will communicate with ANVISA on your behalf during and after the registration process as needed.
- Our in-depth knowledge of the Brazilian medical device market ensures that we provide the most efficient and cost-effective regulatory approval strategy for your device.