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Brazilian Health Regulatory Agency Introduces New Medical Device Regulation: What You Need to Know
São Paulo, Brazil - The Brazilian Health Regulatory Agency (ANVISA) has introduced a new medical device regulation, RDC 751/2022, which went into effect on March 1, 2023. As part of this new regulation, medical device holders are now required to submit a technical dossier as part of the notification and registration process.
What is a Technical Dossier?
A technical dossier is a comprehensive document that provides detailed information about a medical device, including its characteristics, purpose, method of use, content, special care, potential risks, production process, and additional information. The dossier must be submitted in a structured manner, with each chapter containing specific files and documents.
Key Requirements for the Technical Dossier
According to ANVISA’s new regulation, the technical dossier must include:
- A detailed description of the medical device, including its operation and content
- The purpose for which the medical device is intended, as indicated by the manufacturer
- Restrictions, special warnings, and precautions for use, storage, and transportation
- Forms of presentation of the medical device
- Label models and Instructions for Use (IFU)
- A flowchart containing the stages of the manufacturing process of the medical device
Compliance with Technical Standards
ANVISA may request evidence of compliance with technical standards applicable to the product, such as those set by the Association Brazilian Technical Standards (ABNT) or internationally recognized bodies like the International Organization for Standardization (ISO).
Amending a Notification or Registration
To request an amendment to a notification or registration, applicants must submit a declaration listing the requested amendments along with other required documents and pay any applicable fees.
The Technical File Structure
ANVISA has provided a table outlining the technical file structure for medical devices subject to notification and registration. The table includes chapters on administrative and technical information, detailed description of medical devices, risk management, general summary of clinical evidence, product labeling/packaging, and general manufacturing information.
Stay Informed about Brazil’s Medical Device Market
As Brazil’s medical device market continues to grow, it is essential for companies to stay informed about the latest regulations and requirements. For more information on ANVISA’s new regulation and how it affects your business, contact our Regulatory expert today.