Technical Dossier: How to Prepare It for Medical Device Registration with ANVISA

Introduction

Registering medical devices in Brazil requires meticulous preparation of technical documentation for approval by the National Health Surveillance Agency (ANVISA). A well-prepared technical dossier is essential for ensuring an efficient registration process and reducing the risk of rejection. This article details the essential components of a technical dossier for medical devices and best practices for its preparation in compliance with Brazilian regulations.

What is a Technical Dossier?

A technical dossier is a comprehensive set of documents providing detailed information about a medical device, including its design, manufacturing, performance, safety, and efficacy. This document serves as the basis for regulatory evaluation by ANVISA and is essential for obtaining market authorization in Brazil.

Essential Components of the Technical Dossier

1. Administrative Information
   • Properly completed petition form
   • Proof of payment of the analysis fee (GRU)
   • Company Operating Authorization (AFE)
   • Good Manufacturing Practice (GMP) Certificate
   • Manufacturer’s authorization letter (for importers)
2. Device Description
   • Trade name and technical designation
   • Risk classification according to RDC
   • Product models and variations
   • Accessories and complementary parts
   • Operating principle and mechanism of action
   • Detailed technical specifications
3. Manufacturing Information
   • Manufacturing process flowchart
   • Quality controls applied during production
   • Validation of critical processes
   • Traceability system (including UDI where applicable)
   • Quality system certifications (e.g., MDSAP, ISO)
4. Risk Analysis
   • Risk management according to ISO 14971
   • Identification of potential hazards
   • Risk estimation and evaluation
   • Implemented control measures
   • Residual risks and acceptability
5. Verification and Validation
   • Electrical safety tests (where applicable)
   • Biocompatibility tests
   • Performance and functionality tests
   • Software validation (for devices with SaMD)
   • Clinical studies (when required)
   • Stability and shelf-life evidence
6. Labeling and Instructions for Use
   • Label models compliant with RDC 751/2022
   • Instructions for use (IFUs) in Portuguese
   • Storage and transportation information
   • Warnings, precautions, and contraindications
   • Symbols used and their meanings

Compliance with Brazilian Regulations

Relevant RDCs

ANVISA has several Collegiate Board Resolutions (RDCs) that directly impact the preparation of the technical dossier:

• RDC 848/2024: Safety requirements for medical devices
• RDC 751/2022: Labeling information and registration requirements for medical devices

It is crucial to ensure the technical dossier complies with the latest versions of these regulations, as frequent updates may affect documentation requirements.

Best Practices for Dossier Preparation

1. Organization and Clarity
   • A well-organized dossier facilitates ANVISA’s review process and minimizes technical requirement requests:
   • Detailed index with cross-references
   • Executive summary at the beginning of each section
   • Clear numbering of pages and sections
   • Logical and sequential organization of documents
2. Risk Class Appropriateness
   • The level of detail in the technical dossier should correspond to the risk class of the medical device:
   • Class I (low risk): Basic documentation, submitted as Notification
   • Class II (medium risk): Intermediate documentation, submitted as Notification
   • Classes III & IV (high risk): Comprehensive documentation, including clinical validation, full product registration submission, and GMP Certificate requirement
3. Translation and Adaptation
   • All documents must be submitted in Portuguese or accompanied by a sworn translation. Additionally, it is important to adapt international documentation to the specifics of the Brazilian market rather than simply translating documents prepared for other regulatory authorities such as the FDA or Health Products Regulatory Authority.
4. Critical Review
   • Before submission, a critical review by regulatory affairs experts is highly recommended to identify gaps or inconsistencies that could lead to technical requirements.

Common Challenges and How to Overcome Them

1. Frequent Regulatory Changes
   • ANVISA regularly updates its regulations. Stay informed through:
   • Subscription to regulatory newsletters such as Brazilian MD Market by Brisa
   • Participation in events like Hospitalar
   • Direct contact with ANVISA for specific clarifications
   • Consultation of the Focus ANATEL portal for updates
2. Review Timeframes
   • ANVISA’s review process can be lengthy. To optimize it:
   • Ensure the dossier is complete and meets all requirements
   • Respond promptly to technical requirement requests
   • Consider hiring specialized medical device consulting services in the Brazilian market
3. Requirements for Software as a Medical Device (SaMD)
   • For devices incorporating software as a medical component:
   • Provide detailed documentation on the development lifecycle
   • Include a risk analysis specific to the software
   • Describe implemented cybersecurity measures
   • Present complete software validation documentation

Conclusion

Proper preparation of the technical dossier is a critical factor for successful medical device registration in Brazil. Companies that invest time and resources in developing comprehensive, clear, and regulation-compliant documentation are more likely to obtain faster approvals with fewer technical requirements.

For international manufacturers and importers, understanding the specifics of the Brazilian regulatory system is essential to successfully navigate the complex registration process. Hiring specialized medical device regulatory consulting services can be a valuable investment for companies with no prior experience in the Brazilian market.

A well-prepared technical dossier not only facilitates regulatory approval but also serves as a solid foundation for continuous product lifecycle management in the Brazilian market, including post-registration modifications and vigilance activities.

For more information or assistance in preparing your technical dossier for ANVISA registration, contact our team of regulatory affairs specialists for medical devices in Brazil.

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