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In effect from March 1, 2023, the technical dossier must be planned as described in the Brazilian Health Regulatory Agency, or the Agência Nacional de Vigilância Sanitária (ANVISA)’s new medical device regulation, RDC 751/2022. This blog provides you with an insight on technical dossier Regulatory compliance in accordance with the new resolution.
According to RDC 751/2022, a technical dossier is defined as the document that provides descriptions of the elements that make up the product, indicating the characteristics, purpose, method of use, content, special care, potential risks, production process, and additional information.
For the notification of a medical device and inspection by the National System of Health Surveillance, the medical device holder is required to keep the technical file containing all documents and information updated..
As mentioned above, the technical file is a requirement for the notification of the medical device and should therefore be prepared and available with the company before the notification is submitted.
The following are the essential requirements in a technical dossier:
- A detailed description of the medical device, including the basics of its operation and content.
- The purpose for which the medical device is intended, as indicated by the manufacturer.
- The restrictions, special warnings and precautions for use, and clarifications on the use of the medical device, as well as its storage and transportation.
- The forms of presentation of the medical device.
- The label models and Instructions for Use (IFU).
- A flowchart containing the stages of the manufacturing process of the medical device, along with a description of each step of the process up to the stage of obtaining the finished product, indicating the manufacturing units and their respective stages.
- A description of the safety and performance of the medical device, in compliance with the current regulation that provides the essential requirements for the safety and performance of medical devices.
The evidence of the safety and performance of the medical device must comply with the requirements laid out in the resolution, RDC 546/2021. In addition, ANVISA may request for evidence of compliance with technical standards that are applicable to the products subject to regulation, such as the rules of the Association Brazilian Technical Standards, or the Associação Brasileira de Normas Técnicas (ABNT) or internationally recognized bodies such as the International Organization for Standardization (ISO).
In the case of notified medical devices, the technical file must not be filed with ANVISA; however, the holder must keep this document duly updated. In the case of registered medical devices, the technical file must be filed with ANVISA.
According to Article 15 of RDC 751/2022, to request the amendment of a notification or registration of a medical device, the applicant must proceed with the payment of the corresponding fee, if applicable, and submit a declaration listing the requested amendments along with other required documents, depending on the subject requested.
You are required to request for the technical dossier in a structured manner, dividing it into chapters, according to Annex II of RDC 751/2022, where each chapter must include your respective files.
Table 1 below represents the technical file structure for medical devices, subject to notification and registration with ANVISA, according to Annex II.
Table 1: The Technical File Structure for Medical Devices
Medical Device Technical Dossier | Notification | Registration | ||
Class I | Class II | Class III | Class IV | |
Chapter 1 | ||||
Administrative and Technical Information (Forms Available on the ANVISA Portal) | x | x | x | x |
List of Devices (Models/Components/Variants) | x | x | x | x |
Chapter2 | ||||
Detailed Description of Medical Devices and Fundamentals of Operation and Action | x | x | x | x |
Package Description and Presentation Forms of the Device | x | x | x | x |
Intended Purpose (Purpose of Use), Purpose of Use, Intended User, Indication of Use | x | x | x | x |
Environment/Intended Use Context | x | x | x | x |
Contraindications of Use | x | x | x | x |
Global Trading History | x | x | x | x |
Chapter 3 | ||||
Risk Management | x | x | x | x |
List of Essential Safety and Performance Requirements | x | x | x | x |
List of Technical Standards | x | x | x | x |
Physical and Mechanical Characterization | x | x | x | x |
Material Characterization/Chemistry | x | x | x | x |
Electrical Systems: Safety, Mechanical Protection, and Environmental and Electromagnetic Compatibility | x | x | x | x |
Software/Firmware Description | x | x | x | x |
Biocompatibility Assessment | x | x | x | x |
Pyrogenicity Assessment | x | x | x | x |
Safety of Biological Materials | x | x | x | x |
Sterilization Validation | x | x | x | x |
Residual Toxicity | x | x | x | x |
Cleaning and Disinfection of Reusable Products | x | x | x | x |
Usability/Human Factors | x | x | x | x |
Product Expiration Date and Validation of Packaging/Stability Study | x | x | x | x |
Chapter 4 | ||||
General Summary of Clinical Evidence | x | x | x | x |
Relevant Clinical Literature | x | x | x | x |
Chapter 5 | ||||
Product Labeling/Packaging | x | x | x | x |
User Instructions/User Manual | x | x | x | x |
Chapter 6 | ||||
General Manufacturing Information (Manufacturing Unit Addresses) | x | x | x | x |
Manufacturing Process (Flowchart) | x | x | x | x |
Project Information and Involvement | x | x | x | x |
Note: The medical device technical dossier structure is aligned with the Non-In Vitro Diagnostic Device Market Authorization Table of Contents (nLvD MA ToC), IMDRF/RPS WG, 2019, Final Edition, of the International Medical Device Regulators Forum (IMDRF), and it can be updated for possible future editions.
To better organize and identify information, each chapter should be inserted into a file, and depending on the volume of information in a particular chapter, a file should be included for each item. The structuring of information into separate files allows for correct identification and organization and ensures that all necessary information is provided.
If you are looking forward to launching your medical device in the Brazilian market, and if you would like to gain more insight on Brazil’s medical device market, reach out to our Regulatory expert. Stay informed! Stay compliant!
