Brazilian Good Manufacturing Practices Certification
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ANVISA resolution RDC 665/2022 outlines the Brazilian Good Manufacturing Practices (BGMP) requirements for medical devices. Manufacturers of class III and IV medical devices must obtain BGMP certification.
BGMP certification can be acquired through an on-site audit by ANVISA, review of Quality Management System (QMS) documentation, or assessment of the Medical Device Single Audit Program (MDSAP) report. ANVISA is a member of the International Medical Device Regulators Forum (IMDRF) and participates in the MDSAP alongside Australia, Canada, Japan, and the United States.
Foreign manufacturers seeking BGMP certification must apply through a Brazilian Registration Holder, who will also hold the certificate issued by ANVISA. DOMO Salute offers pre-inspection and inspection support to help align your QMS with ANVISA's and MDSAP's requirements and assist during audits. We collaborate with you to develop and execute a plan to enhance your GMP quality and compliance programs, leveraging our expertise and experience.