Registration of medical
devices and in vitro
diagnostics with ANVISA
Brazil is the largest market for medical devices in Latin America.
Fill out the form and wait contact a consultant.
Registration of medical devices and in vitro diagnostics with ANVISA
Brazil is the largest market for medical devices in Latin America.
A fast-growing market
With a well-established and complex regulatory system, the marketing of medical devices in Brazil is only allowed after meeting all the requirements of the National Health Surveillance Agency (ANVISA).
What is the process like in Brazil?
The first step in the Brazilian regulatory process is to determine the correct classification of your medical device. Lower risk (Class I and II products) will follow the registration route which includes a simplified application – notification. Higher risk (Class III and IV devices) must follow the standard registration process.
The application of the regulatory requirement will depend on the classification of the device. The correct classification of your device is essential.
A fast-growing market
With a well-established and complex regulatory system, the marketing of medical devices in Brazil is only allowed after meeting all the requirements of the National Health Surveillance Agency (ANVISA).
What is the process like in Brazil?
The first step in the Brazilian regulatory process is to determine the correct classification of your medical device. Lower risk (Class I and II products) will follow the registration route which includes a simplified application – notification. Higher risk (Class III and IV devices) must follow the standard registration process.
The application of the regulatory requirement will depend on the classification of the device. The correct classification of your device is essential.
- Class I or II
For Class I or II devices, you must submit an application and legal documents to ANVISA for analysis and approval. Manufacturers of Class I and II devices must also compile a comprehensive technical dossier for their BRH to keep on file, with the proposed labeling, instructions for use and other documents that make up the technical dossier, in case of an ANVISA audit.
- Class III and IV
Class III and IV devices must prepare a Technical File that includes clinical data, clinical studies and additional device information. Legal documents, instructions for use and proposed labeling are also included in the Technical File.
Note: Class III and IV registrations expire after ten years and require certification of Good Manufacturing Practices issued by ANVISA;
Class I and II registrations do not expire and do not require certification of Good Manufacturing Practices issued by ANVISA.
- Class I or II
For Class I or II devices, you must submit an application and legal documents to ANVISA for analysis and approval. Manufacturers of Class I and II devices must also compile a comprehensive technical dossier for their BRH to keep on file, with the proposed labeling, instructions for use and other documents that make up the technical dossier, in case of an ANVISA audit.
- Class III and IV
Class III and IV devices must prepare a Technical File that includes clinical data, clinical studies and additional device information. Legal documents, instructions for use and proposed labeling are also included in the Technical File.
Note: Class III and IV registrations expire after ten years and require certification of Good Manufacturing Practices issued by ANVISA;
Class I and II registrations do not expire and do not require certification of Good Manufacturing Practices issued by ANVISA.
INMETRO or ANATEL certification requirements
Some medical devices must be certified by the National Metrology Institute (INMETRO) and/or ANATEL (Telecommunications Regulatory Agency). INMETRO certification is often required for electromedical devices subject to IEC 60601, as well as some other medical devices.
QR Consulting plays this role by connecting your company with an INMETRO and/or ANATEL certifier and represents your company in Brazil.
Quick registration of your product in Brazil
QR Consulting has the knowledge and experience necessary to define the strategy and correct classification for your device, assist in all stages of preparing and submitting your application to ANVISA and monitor the entire process, ensuring speed in the search for authorization of medical devices in Brazil.
Meet some of our partners:
A structure dedicated to the development of your business.
A structure dedicated to the development of your business.
Fill out the form and wait contact a consultant.
