,Brazil Good Manufacturing Practice (B-GMP) Quality System Compliance Overview
Brazil GMP (Good Manufacturing Practices) standards are key regulatory benchmarks in Brazil. They apply to the manufacturing of medical products, pharmaceuticals, and food. For medical devices and IVDs guidelines are provided in (Brazilian Resolutions) RDC 665/2022 and RDC 497/2021. These align with the FDA's Quality System Regulation (21 CFR part 820) and ISO 13485, though there are significant differences.
These regulations are enforced by the National Health Surveillance Agency (ANVISA - Agência Nacional de Vigilância Sanitária). They ensure that production and control processes meet high-quality standards.
For compliance, foreign manufacturers of Class III and Class IV medical devices must submit Brazil GMP inspection requests through a Brazil Registration Holder (BRH). The BRH will then own the certificate issued by ANVISA. This ensures products meet Brazil's strict safety and quality standards.
Freyr has an in-house office in Brazil with medical device regulatory experts to streamline the approval process. For expert assistance, contact Freyr's specialists.
Freyr Brazil GMP (B-GMP) Competencies:
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Consultation on Brazil GMP Compliance![]()
Assisting in preparing for ANVISA GMP certification![]()
Develop B-GMP Compliant Documentation and Team Training![]()
Robust Quality Management Systems Implementation and gap assessment![]()
End- to- end Regulatory Affairs Support![]()
Maintaining and updating of certification (as required)![]()
Audit and Inspection Preparedness![]()
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Creation and management of comprehensive technical documentation![]()
Post-Market Surveillance Support![]()
CAPA System Implementation
Frequently Asked Questions (FAQs)
ANVISA offers three main pathways to obtain a B-GMP certificate:
- On-site Inspection: Involves ANVISA officials conducting an in-person inspection of the manufacturing facility to ensure B-GMP compliance, offering a comprehensive assessment but may incur higher costs and longer timelines.
- Evaluation of Documents and Third-Party Audit Report: Allows submission of detailed documentation of the quality management system and a valid audit report from a recognized third-party auditor, potentially offering a faster and less costly certification process.
- Leveraging the Medical Device Single Audit Program (MDSAP): Utilizes MDSAP audit reports for B-GMP certification, efficient for participants but not universally applicable.
General pathway for B-GMP Certification:
- Submit Application: Send formal application, documentation, and fees to ANVISA.
- Review: ANVISA evaluates the submission.
- Certificate Issuance: If compliant, ANVISA issues a B-GMP certificate valid for two years.
- Surveillance Audits: ANVISA conducts periodic checks to ensure ongoing compliance.
- B-GMP certificate is mandatory for manufacturers who seeking to register and sell Class III and IV medical devices in Brazil, it's not mandatory for all classes (Under general circumstance it is not required for Class I and Class II but it is recommended to compliant with Brazilian quality management system, however certification for these device is not mandatory).
- Compliance with B-GMP rules is obligatory for all enterprises that manufacture items under Brazilian health regulations. Manufacturers must comply with B-GMP rules, even if they do not require a certificate for their medical devices.
- No, compliance with ISO 13485 does not a guarantee compliance with Brazil-GMP (B-GMP) requirements for entering the Brazilian market.
- ISO 13485 and Brazil-GMP (B-GMP) both aim at quality management for medical devices but differ significantly; ISO 13485 is a broad standard that applies throughout the device's life cycle, including design and servicing, whereas Brazil GMP focuses on manufacturing procedures to ensure product quality during production. B-GMP is adapted to fit specific Brazilian requirements, as opposed to the more widely used ISO 13485. B-GMP is a regulatory requirement for putting medical devices into market
- Hence, compliance with ISO 13485 can be a good starting point but may not be sufficient to meet all B-GMP requirements for entering the Brazilian market.
- Manufacturers should still assess the specific Brazil GMP requirements for their products and ensure their practices align with them.
Medical Device Regulatory Consulting – Proven Expertise
Why Freyr?
- Independent Representation and Regulatory Support.
- Continuous Liaison with the Agency for Submissions, Queries, and Feedback.
- Single Point of Contact in the Country for Liaison with the Regulatory Agency.