Brazil is the largest
medical device market
in Latin America.
Registration of medical device, IVD, Cosmetics and Sanitizing with ANVISA.
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Brazil is the largest medical device market in Latin America.
Registration of medical device, IVD, Cosmetics and Sanitizing with ANVISA.
A fast-growing market.
With a well-established and complex regulatory system, the sale of medical devices in Brazilian territory is only allowed after meeting all the requirements of the National Health Surveillance Agency (ANVISA).
A fast-growing market.
With a well-established and complex regulatory system, the sale of medical devices in Brazilian territory is only allowed after meeting all the requirements of the National Health Surveillance Agency (ANVISA).
How is the process in Brazil?
The first step in the Brazilian regulatory process is to determine the correct classification of your medical device. The lowest risk (Class I and II products) will follow the registration route that 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 device classification. Correct classification of your device is essential.
How is the process in Brazil?
The first step in the Brazilian regulatory process is to determine the correct classification of your medical device. The lowest risk (Class I and II products) will follow the registration route that 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 device classification. 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 review and approval. Manufacturers of Class I and II devices must also compile a comprehensive technical file for their BRH to keep on file, with the proposed labeling, instructions for use and other documents that make up the technical file, in the 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 Good Manufacturing Practices certification issued by ANVISA;
Class I and II registrations do not expire and do not require Good Manufacturing Practices certification issued by ANVISA.
- Class I or II
For Class I or II devices, you must submit an application and legal documents to ANVISA for review and approval. Manufacturers of Class I and II devices must also compile a comprehensive technical file for their BRH to keep on file, with the proposed labeling, instructions for use and other documents that make up the technical file, in the 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 Good Manufacturing Practices certification issued by ANVISA;
Class I and II registrations do not expire and do not require Good Manufacturing Practices certification issued by ANVISA.
INMETRO or ANATEL certification requirements
Some medical devices must be certified by the National Institute of Metrology (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 performs this role by connecting your company with an INMETRO and/or ANATEL certifier and representing your company in Brazil.
INMETRO or ANATEL certification requirements
Some medical devices must be certified by the National Institute of Metrology (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 performs this role by connecting your company with an INMETRO and/or ANATEL certifier and representing your company in Brazil.
Agility in registering your product in Brazil.
Agility in registering your product in Brazil.
QR Consulting has the knowledge and experience necessary to define the strategy, correct classification for your device, assist in all stages of preparation and submission of your application with ANVISA and monitor the entire process, ensuring speed in the search for authorization of medical devices in Brazil.
Check some of our clients:
Check some of our clients:
