BGMP
Certification
Management

Complying with Brazil’s quality standards for Class III and IV Medical Devices

Brazilian Good Manufacturing Practices (BGMP) Certification is mandatory for Class III and IV medical devices. Manufacturers must meet ANVISA’s requirements to demonstrate quality and safety before entering the Brazilian market.

Certification pathways

ANVISA can grant BGMP certification through one of three pathways:

• On-site inspection by ANVISA;
• Review of the submitted documentation;
• Evaluation of a valid MDSAP (Medical Device Single Audit Program) audit report.

As a founding member of the International Medical Device Regulators Forum (IMDRF), ANVISA recognizes MDSAP reports from audits performed in partnership with regulators from Canada, the U.S., Australia, and Japan — streamlining compliance for many manufacturers.

MDSAP: A strategic path to BGMP Certification

Manufacturers certified under the Medical Device Single Audit Program (MDSAP) can benefit from a more strategic path to ANVISA’s BGMP certification. When using an MDSAP audit report, the BGMP certificate can be issued with a validity of four years — twice as long as the standard route.

In addition to the extended validity, this path often accelerates ANVISA’s review, making it an ideal option for companies looking to streamline their certification process and stay ahead of regulatory timelines.

We can help you confirm if this route is right for your product and take care of every step, no
matter which certification path you need to follow.

Your local partner for BGMP Certification

Only a legal representative based in Brazil can submit a BGMP petition and hold the certification issued by ANVISA. As your local partner, DOMO Salute takes on this role — filing the petition, reviewing your
documentation, and supporting you through the certification process.

Our team works closely with ANVISA to make sure every step meets regulatory expectations and keeps your project moving forward.