Brazil Registration Holder (BRH)

Foreign medical device manufacturers that do not have a physical presence in Brazil must select a Brazil Registration Holder (BRH). The BRH serves as a liaison between the manufacturer and the National Health Surveillance Agency (ANVISA) in Brazil, oversees the medical device's registration in Brazil, and is listed on the device registration. Companies must keep their BRH for as long as medical products are sold in Brazil (ANVISA), and it cannot easily be transferred without the cooperation of your original BRH, so choose your representative carefully.

Pre-requisites/Qualifications to Act as the Brazil Registration Holder (BRH)

To offer medical device services in Brazil, it's essential that the Brazil Registration Holder (BRH) is a legally registered entity in the country. Although residency in Brazil isn't strictly required, the registration must be accomplished through either a local Brazilian company or a foreign company with a legally established branch office in Brazil. This ensures compliance with the necessary regulations and establishes a legitimate presence for providing services in the Brazilian market.

The BRH is responsible for the submission of registrations and overseeing B-GMP certification in Brazil. It is required to have one single designated BRH.  A BRH that has been allocated to a device cannot be transferred without the assistance of the original BRH. Such transfers need to be done according to the RDC 102/2016 guidelines.

This entity must adhere to the Brazil medical device approval requirements and is accountable to health authorities for any technical issues, adverse events, public health crises, alerts, field actions, and other events related to their products that may have an impact on health safety. The registration holder must ensure that all documentation, including evidence of registration or free trade certificates for imported medical devices, is up to date and complies with ANVISA standards.

The register holder must also keep a valid Certificate of Good Manufacturing Practices (CBPF) granted by ANVISA or have a protocol request for such a certificate in line with RDC No. 751/22 and other applicable legislation.

Primary responsibilities of Brazil Registration Holder (BRH)

• BRH is responsible for the legal registration and BGMP certification of health products in Brazil, including registro and cadastro procedures.
• BRH must promptly address technical complaints, adverse events, and other health-related issues, providing necessary documents for technovigilance when requested by SNVS. Any changes by the manufacturer should be communicated to ANVISA.
• BRH ensures consistency in product information as reported in notification or registration processes.
• BRH maintains the product technical dossier, legal documents, label, and IFU for ANVISA inspections.
• BRH assumes legal responsibility for information examination and product quality, especially for in vitro diagnostic products.
• BRH conducts technical reviews for used imported equipment.