The importance of grouping of devices is pivotal to regulatory strategy as it determines how devices can be authorized in a regulatory submission.
Accessories to medical equipment require a separate registration if one of the following conditions apply: the manufacturer is different; it is not an active accessory and is subject to authorization by ANVISA as a material, IVD, sanitizer, cosmetic, medical product et al; or it is a nonactive accessory with a higher risk classification than the medical equipment.
In the case of medical devices classified as materials, the initial step is to determine if the device is listed on the specific regulation (Normative Instruction (IN) 101/2023). If not, manufacturers shall assess grouping based on the general grouping regulation (RDC 556/2021).
Class I and II devices are subject to Notification (notification) and class III and IV are subject to Registro.
Registration Routes in Brazil
The BRH and their regulatory team should determine the correct classification of their medical device according to Brazilian Regulations.
REGISTER: Class I and II devices
- Follow the Notification route, which includes a simplified application and requires no review by ANVISA.
- Brazilian Registration Holder (BRH) is necessary for Notification
- You must submit an application and the required documents to ANVISA
- Manufacturers must support and share a complete technical dossier for their Brazilian Registration Holder (BRH).
- A BRH must always keep on file, along with the Brazilian dossier, labeling and IFUs, in case of an on-site inspection by ANVISA.
- Class I and II registrations do not expire.
REGISTER: High-risk Class III and Class IV devices
- Follow the registration process.
- Brazilian Registration Holder (BRH) is necessary for Registration
- Manufacturers must prepare a Technical File that includes clinical data, clinical studies, and additional information about the devices.
- A BRH must always keep on file, along with the Brazilian dossier, Legal Documents, labeling and IFUs, in case of an on-site inspection by ANVISA.
- Class III and Class IV registrations expire after ten years.
- INMETRO certification is often required for electromedical devices subject to IEC 60601, as well as some other medical devices.
- ANVISA requires certain medical devices to be certified by the National Institute of Metrology, Standardization and Industrial Quality (INMETRO), which is responsible for establishing technical standards in Brazil.
Learn more about
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.