06.11.12
Brazil’s Registration Process: Initial Steps
Medical device registration according to ANVISA requirements begins with the classification of a product.
Brazil has a four-tier, risk-based classification system (Class I, II, III and IV). AVISA’s Brazilian Resolution RDC 185/01 Annex II contains rules manufacturers should use in order to properly classify their devices according to Brazilian standards.
Accurate classification is essential to determine the proper ANVISA regulatory pathway. Some Class I and II devices qualify for the simplified cadastre process rather than the standard registration process. This process entails having to provide less information to ANVISA for your device, as well as shorter review times.
In-country representation also is required of foreign manufacturers that have no local presence in Brazil. A foreign firm must appoint an in-country representative (known as a Brazilian Registration Holder or BRH) at the beginning of its registration process. Responsibilities of the BRH include controlling the registration process locally in Brazil as well as liaising on the company’s behalf with Brazilian regulators. It is critical to ensure that the BRH has a valid Company Working Allowance permit in accordance with IN 01/94, which authorizes the BRH to import, distribute, sell and store products in Brazil.
Electrical safety testing and certification also may be required for some medical devices with electrical components. Testing and certification are conducted by Brazil’s National Institute of Metrology, Quality and Technology (INMETRO) laboratories according to RDC 27/2011, but in some instances ANVISA will accept electrical safety testing conducted outside Brazil. In order to qualify for this allowance, a company’s device testing must be less than two years old and from an International Laboratory Accreditation Cooperation (ILAC)-certified laboratory.
Next, you must determine whether your device requires an Economic Information Report based on RDC 185/06 mandates. An Economic Information Report contains price comparisons for other countries, patient or user information and device marketing materials that include:
ANVISA also may require clinical data for high-risk and innovative medical devices, but results of clinical trials conducted in other markets often are acceptable to Brazilian regulators.
Medical device registration according to ANVISA requirements begins with the classification of a product.
Brazil has a four-tier, risk-based classification system (Class I, II, III and IV). AVISA’s Brazilian Resolution RDC 185/01 Annex II contains rules manufacturers should use in order to properly classify their devices according to Brazilian standards.
Accurate classification is essential to determine the proper ANVISA regulatory pathway. Some Class I and II devices qualify for the simplified cadastre process rather than the standard registration process. This process entails having to provide less information to ANVISA for your device, as well as shorter review times.
In-country representation also is required of foreign manufacturers that have no local presence in Brazil. A foreign firm must appoint an in-country representative (known as a Brazilian Registration Holder or BRH) at the beginning of its registration process. Responsibilities of the BRH include controlling the registration process locally in Brazil as well as liaising on the company’s behalf with Brazilian regulators. It is critical to ensure that the BRH has a valid Company Working Allowance permit in accordance with IN 01/94, which authorizes the BRH to import, distribute, sell and store products in Brazil.
Electrical safety testing and certification also may be required for some medical devices with electrical components. Testing and certification are conducted by Brazil’s National Institute of Metrology, Quality and Technology (INMETRO) laboratories according to RDC 27/2011, but in some instances ANVISA will accept electrical safety testing conducted outside Brazil. In order to qualify for this allowance, a company’s device testing must be less than two years old and from an International Laboratory Accreditation Cooperation (ILAC)-certified laboratory.
Next, you must determine whether your device requires an Economic Information Report based on RDC 185/06 mandates. An Economic Information Report contains price comparisons for other countries, patient or user information and device marketing materials that include:
- Device pricing in other markets;
- Potential number of patients using your device in Brazil;
- Planned price in Brazil for your device; and
- List of comparable products along with their prices.
ANVISA also may require clinical data for high-risk and innovative medical devices, but results of clinical trials conducted in other markets often are acceptable to Brazilian regulators.