The new medical device regulation for Brazil, Regulation RDC No. 751/2022, issued on 21 September 2022, is now in force as of 01 March 2023. The Brazilian Health Regulatory Agency (ANVISA) updated the prior regulation (No. 185/2001) to provide for risk classification, notification and registration regimes, and labeling requirements and instructions for use of medical devices and their accessories. Here we will review some of the changes presented by the new regulation for Brazil.
Overall, the definitions section in No. 751/2022 is greatly expanded to include many terms not previously defined. Among the significant changes presented is the addition of definitions (and classification) for Software as a Medical Device (SaMD) and nanomaterials. This update closely aligns with the EU Regulation 2017/745, allowing for some degree of harmonization.
While the classification scheme is the same as before (Classes I – IV), each class is now assigned a risk level:
- Class I – low risk
- Class II – medium risk
- Class III – high risk
- Class IV – maximum risk
Device classification rules are located in Annex I of the new regulation. Separate regulations that were issued in the past few years allowed for a simplified pathway for lower risk devices, namely through the notification process for Class I and Class II medical devices. These resolutions are incorporated into Regulation 751/2022. Class III and IV medical devices still go through a registration process. Registration is valid for 10 years. Procedures for both notification and registration are described in the new regulation.
There are a number of other notable changes. All devices require a Medical Device Technical Dossier, following the IMDRF’s Table of Contents structure. For Class I and Class II devices, you will not need to submit dossiers to ANVISA, but you should be prepared as your files might be reviewed during an audit.
Also new to the scene is the Documentary Repository of Medical Devices, which will be available on ANVISA’s electronic portal. This repository is used for storing and making available documents related to both notified and registered medical devices. In particular, it is a requirement to upload the Instructions for Use. For medical devices being notified or registered, or for those devices already marketed in Brazil where there has been a reportable change, the petition and uploading of the Instructions for Use must be performed within 30 days after publication in the Official Gazette of the Union. For non-reportable changes to those devices already notified or registered devices and where there has been a change to the Instructions for Use, the time frame is 180 days.
Notification and registration activities are the responsibility of and are carried out by the holder of the notification or registration. Referred to as “importer” in the previous regulation, this role is now referred to in the new regulation as the “Brazil Registration Holder” (BRH).
In light of these many changes, if you’re planning to newly market a medical device in Brazil but haven’t registered product in Brazil in recent years, you’ll want to familiarize yourself with all of the changes which now apply.
What does all this mean to a medical device manufacturer who already has product in Brazil? The first thing would be to perform a gap assessment against the new regulation. For instance, review the classification rules for your products. If a device has been up-classified, you’ll have time, but new documents will need to be submitted by 29 February 2024.
For the full regulation, see the links provided below. ANVISA also offers a “Questions and Answers” FAQ on their website.
Please note that this regulation does not apply to used, refurbished, custom-made, or in vitro diagnostic medical devices.
Natalie Vollrath, RAC – MEDIcept Sr. Regulatory Consultant