BRH: Registration Representation for Foreign Manufacturers

Regulatory Documentation for Registration Holder Service

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 […]

QR Group ensures Quality System (GMP) compliance for manufacturer certification at ANVISA

QR Group specialist evaluating quality system (QMS) for GMP certification with ANVISA.

Learn how QR Group’s Brazil GMP Quality System Compliance service secures GMP certification of foreign manufacturers for registration of class III and IV devices With a focus on quality system compliance, QR Group offers specialized support for GMP certification with ANVISA, essential for international manufacturers of class III and IV medical devices. What is quality […]