ANVISA resolution RDC 16/2013 specifies the requirements regarding the Brazilian Good Manufacturing Practices (BGMP) for medical devices. Manufacturers of class III and IV medical devices must be certified in compliance with the BGMP requirements.

The BGMP certification is obtained through ANVISA’s on-site audit, review of your QMS documentation, or through the analysis of the MDSAP (Medical Device Single Audit Program) audit report. ANVISA is a member of the IMDRF (International Medical Device Regulators Forum) and, along with four other countries – Australia, Canada, Japan and the United States – composes the MDSAP’s participating regulators.

BGMP application for foreign manufacturers must be requested by a Brazilian Registration Holder, who will also be the holder of the certificate issued by ANVISA. In order to set the Quality Management System (QMS) according to ANVISA`s and MDSAP`s requirements as well as support the manufacturer during the audit, DOMO Salute offers pre-inspection and inspection accompanying services. We will work with you to define, draft, and execute a plan to optimize your GMP quality and compliance programs, bringing expertise and experience.

If you have a regulatory audit coming up, make sure you are ready by having a pre- audit performed by one of our experienced consultants.