Representation for foreign manufacturers
Brazilian Registration Notification or Registry Holder (BRH)
Foreign companies without a local presence in Brazil must appoint a Brazilian Registration Holder (BRH) to represent their medical devices in the country. The BRH is critical in ensuring compliance with ANVISA regulations and facilitating market entry.
Responsibilities of the Brazilian Registration Holder
The BRH, a legal entity recognized by ANVISA, acts as the Requester before device clearance and assumes responsibility for the device's commercialization after approval. The BRH can be the manufacturer, importer, or another authorized representative, and their details must appear on the device's labeling.
Key responsibilities include:
- Managing the Brazilian Good Manufacturing Practice (B-GMP) certification process to ensure compliance with Brazilian quality standards.
- Handling reportable events, recalls, renewals, and modifications of device registrations.
- Ensuring the device is approved by ANVISA and can legally enter the Brazilian market.
ANVISA allows registration holders to authorize multiple companies to import products, providing flexibility for manufacturers. By appointing an independent BRH, manufacturers can:
- : Maintain control over the distribution chain and minimize reliance on a single importer or distributor.
- Add or change distributors as needed without disrupting the device’s market authorization.
A local BRH ensures compliance with Brazilian regulations, smooths the approval process with ANVISA, and facilitates the supply of products in the Brazilian market. This partnership is vital for successfully navigating the complex regulatory landscape and ensuring ongoing market presence.
Qserve provides expert guidance in appointing a reliable BRH, ensuring compliance with ANVISA, and streamlining your market entry into Brazil.
Additional Regulatory Requirements
Brazilian Good Manufacturing Practices (B-GMP) certification
All manufacturers seeking to register medical devices in Brazil must comply with Brazilian Good Manufacturing Practice (B-GMP) requirements, regardless of the device’s risk classification. B-GMP focuses on the quality control processes for manufacturing devices, complementing the technical requirements of the devices themselves.
B-GMP Compliance for Class I and II Devices
For Class I and II devices submitted through the Notification route (Notificação), manufacturers must:
- Declare their knowledge of and adherence to B-GMP standards.
- Ensure their processes align with B-GMP guidelines as part of the submission process.
B-GMP Certification for Class III and IV Devices
The process begins with a formal protocol requesting B-GMP certification for Class III and IV devices submitted through the Registration route (Registro). The device registration is contingent upon the issuance of the B-GMP certificate, which requires:
- ANVISA conducted an on-site audit of every factory unit involved in production.
- Verify compliance with Brazilian quality standards before market approval.
B-GMP certificates are valid for two years, and after this period, ANVISA may grant recertification based on documentation analysis rather than requiring another on-site inspection for overseas manufacturers. While an MDSAP certificate serves as a helpful reference and can accelerate the B-GMP approval process, it does not replace the requirement for B-GMP certification.
B-GMP certification is essential for demonstrating the quality and reliability of medical devices in the Brazilian healthcare market. Compliance ensures manufacturers meet Brazil's stringent standards, gaining the trust of regulators and healthcare providers.
Qserve’s regulatory experts guide you through the B-GMP compliance process, from preparation to successful certification, ensuring a smooth pathway to market entry in Brazil.
ANVISA Certification
INMETRO certification
ANVISA requires that certain medical devices, such as electro-medical devices subject to IEC 60601, are certified by the National Institute of Metrology, Standardization and Industrial Quality (INMETRO). INMETRO itself does not conduct certification; it is an accredited Certification Bodie. Tests for electro-medical products performed outside Brazil are usually accepted if based on recognized standards. Certified products will present an INMETRO mark.
ANVISA Certification
ANATEL certification
ANVISA also requires that medical devices and/or their accessories that have telecommunications modules in their technical characteristics, such as wireless communication modules, Bluetooth, wifi, a cellular interface, etc., using telecommunication/wireless communication, are certified by the National Agency for Telecommunications (ANATEL).
Language requirements
How to communicate with the authorities?
The submission documentation can be set up in Portuguese, English, or Spanish. However, the label and the IFU must be written in Portuguese. In addition, ANVISA publishes its resolutions in Portuguese as well.
Qserve presents Brazilians in the team who can help with ANVISA communication.
Regulatory timelines and fees
How long does it take to enter
the Brazilian medical device market?
Fees and timelines required to register a medical device in Brazil can vary significantly depending on various factors, including the complexity of the device, the quality of the documentation submitted, the device's risk class, and the efficiency of the submission process.
Important links and guidance documents
Where to find more information?