What is the purpose of RDC 687/2022?

RDC 687/2022 establishes the certification process for verifying GMP compliance of Class III-IV medical device manufacturers through mandatory ANVISA inspections, ensuring quality systems meet RDC 665/2022 requirements before product registration.

Which manufacturers require GMP certification?

Class III and IV medical device manufacturers require ANVISA GMP certification under RDC 687/2022. This applies to Brazilian manufacturers, foreign manufacturers with Brazilian legal representatives, and any manufacturer supplying high-risk devices to Brazil.

What is the step-by-step certification process?

GMP certification process includes: 1) Application submission with documentation, 2) ANVISA documentation review (30-60 days), 3) Inspection scheduling, 4) On-site inspection (3-5 days), 5) CAPA implementation for findings, 6) ANVISA verification, 7) Certificate issuance (total 6-12 months).

What are the certification costs and fees?

Certification costs include ANVISA application fee (varies by manufacturer type), inspection fee (covering inspector travel for foreign sites), and optional consultant fees. Total costs typically range R$30,000-R$100,000+ depending on facility complexity and location.

How does MDSAP certification work in Brazil?

MDSAP (Medical Device Single Audit Program) certification is fully recognized under RDC 687/2022 as evidence of GMP compliance. Valid MDSAP certificates eliminate the need for separate ANVISA inspection and provide 4-year certificate validity per RDC 850/2024.

What is the MDSAP certification process for Brazil?

MDSAP certification process involves: 1) Select accredited auditing organization, 2) QMS implementation per ISO 13485 and Brazil requirements, 3) Initial audit (3-5 days), 4) CAPA implementation, 5) Certificate issuance, 6) Submit to ANVISA for B-GMP certificate recognition.

Should manufacturers pursue MDSAP or direct ANVISA certification?

MDSAP is recommended for manufacturers targeting multiple markets or seeking longer certificate validity (4 years). Direct ANVISA certification is suitable for Brazil-only market focus or smaller manufacturers. Consider costs, timeline, and multi-country strategy when deciding.

What documentation is required for certification application?

Certification application requires: quality manual, documented procedures (SOPs), organization chart, product list with classifications, manufacturing site description, quality policy/objectives, and evidence of legal representative (foreign manufacturers). All documents must demonstrate RDC 665/2022 compliance.

What happens during the ANVISA inspection?

ANVISA inspection lasts 3-5 days covering opening meeting, document review, facility tour, process observations, personnel interviews, and closing meeting. Inspectors verify GMP implementation against RDC 665/2022 requirements and issue findings report with conformities and non-conformities.

How should manufacturers prepare for inspection?

Inspection preparation includes: conduct mock audits, organize documentation library, train personnel on inspection procedures, verify equipment calibration status, review recent batch records for completeness, prepare conference room with requested documents, and assign dedicated inspection coordinator.

How long is the GMP certificate valid?

Standard ANVISA GMP certificates are valid for 2 years from issuance. MDSAP-based certificates receive 4-year validity per RDC 850/2024. Certificate expiration requires renewal process including re-inspection (standard) or updated MDSAP certificate submission (MDSAP pathway).

What is the certificate renewal process?

Renewal process mirrors initial certification: submit renewal application 6 months before expiration, provide updated documentation, schedule re-inspection (standard pathway) or submit current MDSAP certificate (MDSAP pathway), address any findings, receive renewed certificate before current expiration.

What happens if the certificate is suspended or revoked?

Certificate suspension or revocation occurs for serious GMP violations, unreported significant changes, or non-compliance with post-market requirements. Suspension temporarily prohibits product sales; revocation permanently cancels certificate requiring complete re-certification. All linked product registrations become inactive.

What are the requirements for foreign manufacturers?

Foreign manufacturers must appoint Brazilian legal representative (importador), demonstrate GMP compliance equivalent to RDC 665/2022, coordinate ANVISA inspection logistics (travel, accommodation, interpreter), and maintain Portuguese-language technical documentation for product registration and inspection.

Can foreign GMP certificates be recognized?

Yes, ANVISA recognizes certain foreign GMP certificates as evidence of compliance. MDSAP certification is fully recognized (4-year validity). Other recognized certificates include FDA, Health Canada, TGA, CE mark with notified body inspection reports, subject to ANVISA verification.

What are the inspection logistics for foreign manufacturers?

Foreign manufacturer inspections require coordination of ANVISA inspector international travel, accommodation arrangements, visa/customs facilitation, qualified interpreter provision, and associated cost coverage. Manufacturers should plan 3-6 months lead time for inspection scheduling and logistics coordination.

RDC 687/2022 FAQ - Updated October 2025

Brazil GMP Certification for Medical Device Manufacturers. Expert guidance by Pure Global regulatory specialists

GMP Certification

Class III-IV

MDSAP Recognition

Inspection-Based

Official Document

Access the official document:Download RDC 687/2022 (English PDF)

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Certification Strategy

MDSAP vs. ANVISA direct certification pathway selection

Inspection Preparation

Mock inspections and documentation readiness for ANVISA audits

CAPA Support

Post-inspection corrective action implementation and closure

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Scope

Class III-IV

Mandatory for high-risk devices

Validity

2-4 years

MDSAP receives 4-year validity

MDSAP

Recognized

Full recognition with benefits

Process

Inspection-based

On-site ANVISA verification

Frequently Asked Questions

On This Page

General Requirements & Certification Process

MDSAP Recognition & Benefits

Documentation & Inspection Procedures

Certificate Validity & Renewal

Foreign Manufacturer Requirements

Quick Resources

All Brazil Regulations How to Choose a Brazil Registration Holder Free Brazil Medical Device Classifier Brazil Medical Device Database Brazil Market Insights & Analytics Classification Game Pure Global Brazil Services

Key Dates & Milestones

PublishedApril 28, 2022

Effective DateMay 31, 2022

MDSAP ExtensionRDC 850/2024 (4-year validity)

ReplacedRDC 122/2020

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Note: This FAQ guide provides general information about regulatory requirements and should not be considered as legal advice. Regulations are subject to change. Always consult with qualified regulatory professionals for specific guidance.

Last updated: October 2025 | Based on RDC 687/2022 official documentation