Titans Medical

Step-by-Step Guide to ANVISA Medical Device Registration.

Introduction

Brazil’s medical device market presents significant opportunities for manufacturers worldwide. However, navigating the regulatory landscape governed by ANVISA (Agência Nacional de Vigilância Sanitária) requires a thorough understanding of the processes involved. This guide provides a comprehensive overview of the ANVISA medical device registration process, tailored for manufacturers seeking market entry into Brazil.

1. Understanding ANVISA and the Regulatory Framework

ANVISA is Brazil’s national regulatory authority responsible for overseeing medical devices, pharmaceuticals, and other health-related products. The regulatory framework has evolved over time, with RDC 751/2022 replacing the earlier RDC 185/2001, aligning Brazil more closely with international standards such as the EU MDR.

2. Device Classification

Medical devices in Brazil are classified into four risk categories:

  • Class I – Low Risk
  • Class II – Medium Risk
  • Class III – High Risk
  • Class IV – Very High Risk

Classification depends on factors such as the device’s intended use, contact duration with the body, and level of invasiveness.

3. Appointing a Brazilian Registration Holder (BRH)

Foreign manufacturers must appoint a local representative, referred to as a Brazilian Registration Holder (BRH). This entity will interact with ANVISA, hold the product license, and ensure regulatory compliance throughout the product lifecycle.

4. Technical Documentation Preparation

A robust technical dossier is vital and may include:

  • Product description and intended use
  • Risk analysis and mitigation strategies
  • Clinical evidence and performance testing
  • Labeling and Instructions for Use (in Portuguese)
  • Quality certificates such as ISO 13485
  • Manufacturing and sterilization process details

For Class III and IV, this documentation must be submitted for review; for Class I and II, it must be maintained by the BRH and be readily accessible.

5. INMETRO Certification (If Applicable)

If your device is electrical, electronic, or electromedical, INMETRO certification may be required. This ensures the product meets Brazil’s safety and performance standards. Devices without this certificate (if applicable) may not be allowed entry into the market.

6. Good Manufacturing Practices (GMP) Certification

For Class III and IV devices, GMP certification is mandatory. ANVISA may conduct an onsite inspection or accept proof through participation in recognized programs like the Medical Device Single Audit Program (MDSAP).

7. Submission to ANVISA

Depending on the device classification, the submission process varies:

Notification (Class I & II)

  • Simplified process with no ANVISA review
  • Instant market access
  • No expiration date

Registration (Class III & IV)

  • Detailed dossier review
  • Registration valid for 10 years
  • Renewal before expiry is mandatory

Submissions are made via ANVISA’s electronic platform, with fees depending on the risk class and product complexity.

8. Post-Approval Requirements

Once approved, manufacturers must:

  • Ensure Portuguese labeling and IFU
  • Maintain compliance with ANVISA’s post-market surveillance rules
  • Report adverse events and product recalls
  • Submit modifications or updates to ANVISA for approval
  • Renew registration for Class III & IV before expiration

9. How Titans Medical Consulting Can Help

At Titans Medical Consulting, we specialize in supporting manufacturers with end-to-end regulatory solutions for the Brazilian market. From device classification and technical documentation to GMP preparation and ANVISA submission, our team provides tailored strategies to ensure faster and smoother market access.

Whether you’re launching a single product or managing a large portfolio, our consultants ensure that every regulatory step is mapped out efficiently. We also offer BRH liaison support, INMETRO coordination, and post-market compliance services.

Conclusion

Successfully registering a medical device with ANVISA requires preparation, clarity on regulatory obligations, and reliable local support. With evolving rules and complex pathways, manufacturers must stay proactive to avoid delays and non-compliance. By working with trusted regulatory partners like Titans Medical Consulting, you gain a strategic edge in entering Brazil’s highly regulated yet rewarding healthcare market.

Sources

  • ANVISA Official Website – www.gov.br/anvisa
  • RDC 751/2022 – Brazilian medical device classification rules
  • INMETRO Guidelines – Brazilian safety standards for medical equipment
  • MDSAP Official Program Information

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