MDRC assists medical device companies worldwide with registration, representation, quality system compliance and distribution in Brazil as shown below.
Determining the proper classification for your medical device is critical to ensuring a smooth registration process. We have many years' experience with Brazil medical device classification.
If you manufacture an electro-medical device, electrical safety testing and INMETRO certification may be required in Brazil. We can help coordinate this testing on your behalf as the results are critical to the completion of the registration documents.
Companies without an establishment in Brazil are required to appoint a Brazilian Registration Holder as an in-country representative and liaison with ANVISA. Having an independent firm control the registration for your device(s) is critical if you will not have a direct sales office in Brazil. Once the Brazil Registration Holder role is appointed, it cannot be transferred. We will help you find a reliable Brazilian Registration Holder.
Like a US FDA 510(k) submission, the Brazilian Technical File provides proof that your product is safe and effective. MDRC will prepare your Technical File and assist with document and IFU translation into Portuguese. We will also advise you on device labeling requirements in accordance with Brazilian regulations.
Brazilian quality system requirements are very similar to US FDA 21 CFR Part 820. Our consultants will advise you on what modifications must be made to your existing quality system to prepare for your biennial ANVISA quality system certification audit.
ANVISA conducts biennial audits of medical device manufacturers selling in Brazil. MDRC is available to conduct preassessment audits to ensure that you, or your major suppliers, are ready for the audits. Internal auditor training is also available.
While your registration is being finalized, our distribution specialists can help you find and evaluate Brazilian distributors in São Paulo, Rio de Janeiro, Salvador and other Brazilian cities as needed. This will increase the chances of finding a partner who is qualified and able to effectively market your products in Brazil.
| Validity | Class I and II Devices do not expire. Class III and IV: Five years. |
| Language | Documents and Labeling must be in Portuguese. |
| Postmarket Surveillance | The company must appoint a person responsible for post-market surveillance who will notify the National System of Health Surveillance (SNVS) of any adverse events. |
| Expected Time | Class I and II Devices: 1-3 months.Class III and IV devices: 3-4 years (due to GMP certification). |
* ANVISA classification model is based on provisions of Mercosur Resolution No. 40 "Mercosur technical regulation of medical products".
**The Company Working Allowance permit, called an “Autorização de Funcionamento,” allows the company to import, distribute, store and sell the product in Brazil. The manufacturer only needs to secure this permit if they will be importing and distributing their own products in Brazil. Otherwise, a distributor or registration holder will already have this permit.
***Testing performed outside Brazil is usually acceptable if performed by an ILAC certified lab.
****The Economic Information Report must include pricing comparisons for other countries, patient/user information, marketing materials, and other data.
^Class I and II devices not listed on the IN 7/2010 list do not need to comply with BGMP and also go through an abbreviated cadaster process.
^^Brazilian Good Manufacturing Practice (B-GMP) is similar to the US FDA Quality System Regulations (21 CFR Part 820).
^^^The manufacturers of class I and II devices are exempt from the obligation to provide a free sale certificate issued in the country of origin. The same rule applies to the certificate of conformity – the absence of this document does not prevent the company from marketing its medical devices in Brazil providing that the appropriate notification has been duly filed to ANVISA. However, the applicant company should be able to provide the aforementioned certificates within 180 days from the date the appropriate request becomes valid, while the failure of the company to provide such certificates will result in the cancellation of the notification. If for some reason, the requested certificates could not be issued, the company is allowed to provide a consolidated report based on test reports issued by testing laboratories.
IMPORTANT NOTE: Risk management in compliance with ISO 14971 is required for all implants, intrauterine devices and blood bags.
* ANVISA classification model is based on provisions of Mercosur Resolution No. 40 "Mercosur technical regulation of medical products".
**The Company Working Allowance permit, called an “Autorização de Funcionamento,” allows the company to import, distribute, store and sell the product in Brazil. The manufacturer only needs to secure this permit if they will be importing and distributing their own products in Brazil. Otherwise, a distributor or registration holder will already have this permit.
***Testing performed outside Brazil is usually acceptable if performed by an ILAC certified lab.
****The Economic Information Report must include pricing comparisons for other countries, patient/user information, marketing materials, and other data.
^Class I and II devices not listed on the IN 7/2010 list do not need to comply with BGMP and also go through an abbreviated cadaster process.
^^Brazilian Good Manufacturing Practice (B-GMP) is similar to the US FDA Quality System Regulations (21 CFR Part 820).
^^^The manufacturers of class I and II devices are exempt from the obligation to provide a free sale certificate issued in the country of origin. The same rule applies to the certificate of conformity – the absence of this document does not prevent the company from marketing its medical devices in Brazil providing that the appropriate notification has been duly filed to ANVISA. However, the applicant company should be able to provide the aforementioned certificates within 180 days from the date the appropriate request becomes valid, while the failure of the company to provide such certificates will result in the cancellation of the notification. If for some reason, the requested certificates could not be issued, the company is allowed to provide a consolidated report based on test reports issued by testing laboratories.
IMPORTANT NOTE: Risk management in compliance with ISO 14971 is required for all implants, intrauterine devices and blood bags.
MDRC assists medical device companies worldwide with registration, representation, quality system compliance and distribution in Brazil as shown below.
Determining the proper classification for your medical device is critical to ensuring a smooth registration process. We have many years' experience with Brazil medical device classification.
If you manufacture an electro-medical device, electrical safety testing and INMETRO certification may be required in Brazil. We can help coordinate this testing on your behalf as the results are critical to the completion of the registration documents.
Companies without an establishment in Brazil are required to appoint a Brazilian Registration Holder as an in-country representative and liaison with ANVISA. Having an independent firm control the registration for your device(s) is critical if you will not have a direct sales office in Brazil. Once the Brazil Registration Holder role is appointed, it cannot be transferred. We will help you find a reliable Brazilian Registration Holder.
Like a US FDA 510(k) submission, the Brazilian Technical File provides proof that your product is safe and effective. MDRC will prepare your Technical File and assist with document and IFU translation into Portuguese. We will also advise you on device labeling requirements in accordance with Brazilian regulations.
Brazilian quality system requirements are very similar to US FDA 21 CFR Part 820. Our consultants will advise you on what modifications must be made to your existing quality system to prepare for your biennial ANVISA quality system certification audit.
ANVISA conducts biennial audits of medical device manufacturers selling in Brazil. MDRC is available to conduct preassessment audits to ensure that you, or your major suppliers, are ready for the audits. Internal auditor training is also available.
While your registration is being finalized, our distribution specialists can help you find and evaluate Brazilian distributors in São Paulo, Rio de Janeiro, Salvador and other Brazilian cities as needed. This will increase the chances of finding a partner who is qualified and able to effectively market your products in Brazil.
