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ANVISA Medical Device Registration and Approval in Brazil

Medical devices in Brazil are regulated by the Agência Nacional de Vigilância Sanitária (ANVISA). Brazil’s base regulations and medical device classification schemes are similar to those found in the European MDD 93/42/EEC.

Cadastro vs. Registro Registration Routes

The first step in the Brazil regulatory process  is to determine the correct classification of your medical device. Lower risk Class I and II devices will follow the Cadastro registration route, which includes a simplified application. Higher risk Class III and IV devices must follow the Registro registration process.

Download our PDF chart explaining each step of the regulatory process

If your device is Class I or II, you must submit an application and legal documents to ANVISA for review and approval, Class I and II device manufacturers must also compile a comprehensive technical dossier for their BRH to keep on file, along with proposed labeling and IFU, in case of an ANVISA audit.

Class III and IV device manufacturers must prepare a Technical File including clinical data, clinical studies, and additional device information in accordance with Annex III Part A, B or C of RDC 185/01 and submit to ANVISA.  Legal documents, IFUs, and proposed labeling are also included in the Technical File.

Learn more about timelines for ANVISA approval

Appointing a Brazilian Registration Holder

Foreign medical device manufacturers that do not have a physical location within Brazil must appoint a Brazilian Registration Holder (BRH). Your BRH will submit your registration application to ANVISA and maintains control of your device registration and Brazil Good Manufacturing Practice (BGMP) certification, if applicable. Hiring an independent BRH instead of using a distributor will give you the freedom to change distributors at any time. 

INMETRO Certification

If your medical device is subject to IEC 60601, you likely need to obtain National Institute of Metrology, Standardization and Industrial Quality (INMETRO) certification from an authorized local certifier in Brazil.

Read more about INMETRO certification

Let Emergo assist you with Brazil’s regulatory approval process

With offices in Sao Paulo and Brasilia, we have helped hundreds of medical device companies navigate the ANVISA regulatory process and start selling in Brazil. Here’s how we can help:

  • We can determine the correct classification for your device, and complete all necessary documentation, to ensure a smooth registration.
  • Appointing us as your Brazilian Registration Holder  will allow you to maintain more control over your registrations and to add or remove distributors at any time.
  • Our experienced consultants can update your existing FDA or ISO 13485 compliant quality system to meet Brazil’s Good Manufacturing Practice (GMP) requirements.
  • We can assist you with INMETRO certification coordination, if necessary.

Please contact us for more information on all of our Brazil registration services.

Ask us for detailed information about Brazil ANVISA registration services.

Learn about the process, costs and timelines.

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Listen to our 7 minute podcast interview on the medical device registration process in Brazil:

Interested in learning more about the medical device registration process in Brazil? Emergo's Ann Marie Boullie, Vice President of Business Development, and Tatiana Sell, International Projects Manager, discuss some of our most frequently asked questions in this podcast interview.


Frequently Asked Questions

 

How long does it generally take for ANVISA approval?

Class I and II applications are approved by ANVISA within seven months. Since Class III and IV device manufacturers must also submit a Brazil GMP certificate to ANVISA, the approval timeframe could be up to four years due to ANVISA’s backlog. These timelines exclude the timeframe for the preparation of your ANVISA registration technical file and associated document translations.

Can I transfer my registration to another company?

In most cases, ANVISA does not allow transfer of a registration. According to Brazilian Resolution RDC 22/2010, registrations can only be transferred under the following scenarios: merger, spinoff, incorporation or succession of the BRH. ANVISA will not allow a transfer of a registration if you want to switch distributors, for example.

Can we accelerate our B-GMP inspection?

In late 2012, some members of the Brazilian medical device association ABIMED filed a lawsuit against ANVISA. This lawsuit requested that ANVISA accept Quality System certifications granted by other international agencies (such as ISO 13485 certification) in situations where ANVISA has not been able to inspect foreign manufacturing sites within six months of the original inspection request.

The judge agreed and now those ABIMED members that were part of that lawsuit, including Emergo, can submit device registrations without the B-GMP certificate. Instead, the device application can be submitted showing proof that you have been waiting six months or longer for your GMP inspection, plus proof of other quality system certification. This saves valuable time and money, as ANVISA is currently backlogged by 3 to 5 years on GMP inspection requests. 

Our device is subject to IEC 60601 series testing. Does this mean we need INMETRO certification?

Most likely, yes. Brazilian Normative Instruction (IN) 9/2013 outlines the standards for which INMETRO applies. If you do need INMETRO certification, your existing test reports can be used if they meet the following criteria: IEC 60601 3rd edition testing conducted through an International Laboratory Accreditation Cooperation (ILAC) member lab; your test reports are less than two years old; your testing was conducted to the standards listed in IN 9/2013. If you don’t have to retest, then you’ll simply need to contract with an INMETRO certifier, who will review your product file and conduct a pre-certification audit. These certificates are valid for 5 years and annual audits are required to maintain your certificate. 

Feel free to download our free PDF chart outlining all of the steps of the Brazil registration process.