What is the purpose of RDC 665/2022?

RDC 665/2022 establishes comprehensive Good Manufacturing Practices requirements for medical device manufacturers to ensure product safety, effectiveness, and quality throughout the entire product lifecycle in Brazil.

Which manufacturers must comply with RDC 665/2022?

All medical device and IVD manufacturers selling products in Brazil must comply. Class I-II manufacturers self-declare compliance. Class III-IV manufacturers require ANVISA GMP certification through mandatory inspections before product registration.

How does RDC 665/2022 differ from RDC 16/2013?

RDC 665/2022 consolidates RDC 16/2013 and IN 8/2013 into a single regulation with updated terminology, clearer requirements, and stronger alignment with ISO 13485:2016 and international regulatory frameworks.

What quality management system requirements must be met?

Manufacturers must establish documented QMS covering management responsibility, resource management, product realization, and measurement/analysis. The system must include quality policy, objectives, planning, documented procedures, and continuous improvement processes per ISO 13485.

What documentation is required for GMP compliance?

Required documentation includes quality manual, documented procedures for all quality system elements, work instructions, specifications, validation protocols, device master records, batch/lot records, technical files, design history files, and quality records demonstrating compliance with all GMP requirements.

What are the management responsibility requirements?

Management must establish quality policy, ensure resource availability, define responsibilities and authorities, conduct management reviews, and demonstrate commitment to GMP compliance. Top management must appoint a management representative responsible for quality system effectiveness.

What design control requirements apply?

Design controls include planning, inputs, outputs, review, verification, validation, transfer, and change control. Manufacturers must document design history files showing how design inputs were translated into outputs meeting user needs and intended use.

Is risk management required under RDC 665/2022?

Yes, risk management is mandatory throughout product lifecycle. Manufacturers must establish risk management processes per ISO 14971, conduct risk analysis during design, implement risk controls, evaluate residual risks, and maintain risk management files for each device.

What production and process control requirements apply?

Production controls include validated processes, environmental controls, equipment qualification, personnel training, batch records, inspection/testing, and traceability. All processes affecting product quality must be validated and monitored to ensure consistent output meeting specifications.

What are the equipment qualification requirements?

Equipment used in production, inspection, and testing must be qualified for intended use, properly maintained, and calibrated. Qualification includes installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) with documented evidence of equipment suitability.

What validation requirements apply to production processes?

Processes that cannot be fully verified by inspection/testing must be validated before routine use. Validation includes protocol development, execution per protocol, data analysis, and documented evidence proving process consistently produces acceptable results. Revalidation required after significant changes.

What inspection and testing requirements apply?

Incoming materials, in-process production, and finished devices must be inspected/tested per documented procedures. Inspection criteria must be defined, measuring equipment calibrated, and inspection records maintained showing conformity to specifications before release.

How must nonconforming product be controlled?

Nonconforming product must be identified, segregated, documented, and dispositioned per established procedures. Disposition options include rework, use-as-is (with justification), scrap, or return to supplier. Reworked product requires re-inspection. All nonconformances must be investigated for root cause.

What post-market surveillance requirements apply?

Manufacturers must establish post-market surveillance systems to collect and analyze device performance data, customer complaints, adverse events, and field issues. Information must be used for risk management updates, corrective actions, and regulatory reporting per RDC 23/2012.

What are the requirements for corrective and preventive actions?

Manufacturers must establish CAPA system to investigate nonconformances, implement corrections, identify root causes, take corrective actions to prevent recurrence, and preventive actions to eliminate potential nonconformances. All CAPA activities must be documented and their effectiveness verified.

RDC 665/2022 FAQ - Updated October 2025

Brazil Good Manufacturing Practices for Medical Devices. Expert guidance by Pure Global regulatory specialists

GMP Requirements

Quality Systems

Mandatory Compliance

All Classes

Official Document

Access the official document:Download RDC 665/2022 (English PDF)

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GMP Implementation

ISO 13485 QMS setup and Brazil-specific GMP compliance

MDSAP Support

Preparation for Medical Device Single Audit Program certification

Audit Readiness

Mock audits and documentation preparation for ANVISA inspections

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Scope

All Classes I-IV

Applies to all medical devices and IVDs

Effective Date

May 2, 2022

Replaced RDC 16/2013

Certification

Class III-IV

Mandatory ANVISA inspection

Alignment

ISO 13485

Harmonized with international standards

Frequently Asked Questions

On This Page

General Requirements

Quality Management System

Design & Development

Production & Process Controls

Inspection & Nonconforming Product

Post-Market Activities

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

PublishedMarch 30, 2022

Effective DateMay 2, 2022

ReplacedRDC 16/2013

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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 665/2022 official documentation