ANVISA Medical Device and IVD Registration and Approval in Brazil

ANSWERED ON THIS PAGE:

• What is the registration process in Brazil?
• Does ANVISA require an in-country representative for foreign manufacturers?
• Are we required to maintain any technical certifications in Brazil?

Brazil's ANVISA medical device regulations

Brazil is the largest medical device market in Latin America, with an established but complex regulatory system. Medical devices in Brazil are regulated by the National Health Surveillance Agency (ANVISA).

With offices in Brasília and São Paulo, Emergo's team in Brazil has the expertise to help you navigate ANVISA's regulatory requirements and begin selling your device in Brazil.

Notificação vs. Registro registration routes in Brazil

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 Notificação registration route, which includes a simplified application and does not require review by ANVISA. Higher-risk Class III and IV devices must follow the Registro registration process.

If your device is Class I or II, you must submit an application and required documents to ANVISA. Class I and II device manufacturers must also compile a comprehensive technical dossier for their Brazil Registration Holder (BRH) to keep on file, along with proposed labeling and IFU, in case of an ANVISA on-site inspection.

Class III and IV device manufacturers must prepare a Technical File that includes clinical data, clinical studies, and additional device information. Legal documents, IFUs, and proposed labeling are also included in the Technical File. Class III and IV registrations expire after ten years; Class I and II registrations do not expire.

Appointing a Brazil registration holder

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

INMETRO certification requirements

ANVISA requires that certain medical devices be certified by The National Institute of Metrology, Standardization and Industrial Quality (INMETRO), which is responsible for the establishment of technical standards in Brazil. INMETRO certification is often required for electro-medical devices subject to IEC 60601, as well as some other medical devices. Emergo can assist with selecting an INMETRO certifier and communicate with them on your behalf.

Let Emergo assist you with Brazil's regulatory approval process

Emergo's team in Brazil has helped hundreds of medical device companies comply with ANVISA's regulatory requirements. Here's how we can help:

• Determine the classification for your device, and complete all necessary documentation to help ensure a smooth registration.
• Act as your Brazil Registration Holder to allow you more control over your registrations and distribution.
• Our experienced consultants can update your existing FDA or ISO 13485 compliant quality system to meet Brazil's Good Manufacturing Practice (B-GMP) requirements.
• Assist with INMETRO, ANATEL and MTE certification coordination, if necessary.

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

Frequently asked questions about ANVISA

How long does it generally take for ANVISA approval?
Registration timelines vary based on your device classification. Download our free Brazil regulatory chart for a more detailed look at ANVISA registration timelines.

Can I transfer my registration to another Brazil Registration Holder?
Brazilian Resolution RDC 102/2016, which went into effect December 25, 2016, allows greater flexibility for registration transfers. However, transfers will require the cooperation of the previous BRH: they must sign the transfer contract and ask ANVISA to cancel the registration under their name. ANVISA will issue a new registration number one the transfer is approved, but the registration will carry the original validity date. Emergo can assist with registration transfer requests.

Do we need Country of Origin approval to be eligible for ANVISA registration?
Based on current regulation, there is a legal requirement to show proof of market authorization in your country of origin. However, there are some provisions for companies that can't meet this requirement. Emergo can advise further if your product is eligible to be registered even if you don't have approval in your home market.