ANVISA resolution RDC 665/2022 outlines the requirements for Brazilian Good Manufacturing Practices (BGMP) for medical devices. Manufacturers of Class III and IV medical devices must be certified in compliance with BGMP requirements.

BGMP certification can be obtained through ANVISA’s on-site audit, a review of the manufacturer’s QMS documentation, or through the analysis of the MDSAP (Medical Device Single Audit Program) audit report. ANVISA, a member of the IMDRF (International Medical Device Regulators Forum) , collaborates with four other countries—Australia, Canada, Japan, and the United States—as part of the MDSAP’s participating regulators.

Foreign manufacturers seeking BGMP certification must apply through a Brazilian Registration Holder, who will also be the holder of the certificate issued by ANVISA. DOMO Salute can assist with the entire petition process and act as the certificate holder, ensuring a smooth and compliant certification journey.