Registration Holder Service: your link with ANVISA

Foreign medical device manufacturers can only distribute in Brazil if they appoint a Brazilian Registration Holder (BRH). This official representative acts as a bridge between your company and ANVISA, assuming legal responsibilities, keeping the registration active, and ensuring the GMP certification necessary for regulatory compliance.

Why a standalone BRH makes a difference

Opting for an independent BRH, rather than a distributor, ensures total flexibility. Unlike what happens with distributors, an independent BRH allows you to change partners without impacting the registration or certification of the product. In addition, this choice protects industrial secrets and design data, as an independent regulatory consultant manages the information with confidentiality and awareness of possible conflicts, such as in the event of a recall, without commercial interests involved.

Expert reliability and regulatory focus

A traditional distributor focuses on sales and marketing, leaving gaps in regulatory and compliance obligations. An independent BRH, on the other hand, by acting exclusively in regulatory matters, ensures detailed technical management of registrations and certifications, ensuring that strategic information remains protected.

QR Group, as a company licensed by ANVISA and without commercial ties with manufacturers, offers a fully reliable registration holder service. This independent structure eliminates business dependencies, ensuring that your product remains registered and certified, even in the event of distributor changes. Contact the QR Group team and find out how the Registration Holder Service can ensure regulatory security and commercial freedom for your operation in Brazil.

Fonte: QR Group