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RDC 665/2022 & RDC 687/2022

ANVISA BGMP & CBPF Compliance (RDC 665/2022)

Brazilian Good Manufacturing Practice expectations for medical devices and IVDs are consolidated in RDC 665/2022. For manufacturers of Class III and IV devices, ANVISA CBPF certification is governed by RDC 687/2022 and related administrative requirements. The regulatory issue is not simply whether the manufacturer holds ISO 13485 certification; ANVISA expects evidence that the applicable Brazilian GMP requirements are effectively implemented.

Prepare for BGMP / CBPF Review

When This Support Is Needed

A Class III or IV medical device or IVD product registration is planned in Brazil
A formal CBPF (Certificado de Boas Práticas de Fabricação) initial application or renewal is required
The manufacturer is preparing for an ANVISA on-site inspection or risk-based desk review
Existing ISO 13485 procedures need to be mapped to Brazilian RDC 665/2022 requirements
ANVISA or an MDSAP auditing organization has identified GMP non-conformances requiring remediation

What We Challenge Before Submission

Can the company demonstrate active implementation through records, not only written SOPs?
Are design changes systematically linked to risk management updates and verification/validation?
Are supplier evaluation and incoming controls commensurate with component/process risk?
Are customer complaints actively feeding CAPA investigations and product risk evaluations?
Can manufacturing sites explain outsourced processes and critical suppliers consistently during audit?

MDSAP Program Considerations for Brazil

Where MDSAP evidence is relevant to ANVISA certification strategy, we assess how the available audit/certificate scope can be leveraged and whether any Brazil-specific gaps (such as tecnovigilância interfaces, RDC 665/2022 technical specifications, and legal manufacturer representation) remain.

Our BGMP & CBPF Support Scope

RDC 665/2022 comprehensive quality-system gap assessment
ISO 13485-to-Brazil Good Manufacturing Practice cross-mapping
Design control and Design History File (DHF) review
Risk-management integration and benefit-risk documentation (ISO 14971)
Supplier controls, critical subcontractor evaluation, and purchasing controls
CAPA, complaint handling, nonconformity management, and root-cause systems
Process validation, cleanroom qualification, and special-process controls
Software validation within the quality management system (IEC 62304 / ISO 13485)
Traceability, Device Master Record (DMR), and Device History Record (DHR) controls
Internal audit and executive management review readiness
Mock inspection, auditor training, and evidence-room / war-room preparation
CAPA strategy, root cause analysis, and formal response for inspection findings
CBPF petition compilation, filing, and status follow-up with ANVISA

Audit Methodology:

We test implementation, not document titles. For each system, we follow objective evidence through the process — procedure, record, decision, risk impact, CAPA and effectiveness — in the same way an experienced ANVISA inspector would.

Prepare for ANVISA BGMP Inspection and Secure CBPF Certification

Our quality system auditors conduct mock audits, remediate RDC 665/2022 gaps, and manage CBPF petition submissions.

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