September 16, 2022
Brazil’s medical device market regulator, ANVISA announced major updates to its Resolution of the Collegiate Board of Directors (RDC) 185/2001. The changes will serve to strengthen the country’s medical device registration regulations upon their effective date of March 1, 2023.
The new regulation, RDC 751/2022 (link in Portuguese), further defines the rules for classifying the risk of medical devices, the requirements for labeling and instructions for use and the procedures for notification or registration of medical devices.
The resolution’s major changes include:
- Adoption of specific classification rules for new technologies including software as a medical device (SaMD) and nanomaterials. The updated classification rules and medical device definitions generally align with EU MDR.
- Consolidation of notification, registration and change rules in a single RDC.
- Incorporation of rules for the Documentary Repository of Medical Devices. Note: this requires uploading the Instructions for Use (IFUs) to an ANVISA portal.
- Adoption of the Table of Contents structure (IMDRF’s Table of Contents) for Technical Dossiers, enabling the use of dossiers prepared for multiple jurisdictions.
- Forecasting situations for depletion of finished products, packaging, labels and IFUs.
- Formalization of the procedural reassessment process.
- General modernization of the text and updating of terminology.
- Inclusion of Brazil Registration Holder (BRH) definition; previously, the BRH was defined as "importer." Manufacturers will need to update their IFU and label information in the next modifications after March 1, 2023.
- IFUs, labels and ANVISA forms must be submitted in Portuguese; other documents may be provided in English.
- Advertising materials must comply with ANVISA requirements.
- Updates to technical reports must be submitted by BRHs during registration modifications (after February 2023).
- New files for up-classified medical devices may be submitted by BRHs through February 29, 2024.
What changes can a medical device manufacturer doing business in Brazil expect?
Medical device manufacturers doing business in Brazil should review the changes in this update to enable market access for their products. The risk classification, procedures, specifications and notification process for medical devices and their accessories in Brazil is mandatory. It’s important to note that in vitro diagnostic (IVD) devices, refurbished medical devices and personalized medical devices are not affected by these updates.
How will the new resolution affect how risk classification works?
Medical devices will be classified according to the level of risk they present to the patient and the regulatory process will change as the risk level increases.
The risk classifications are:
- Low risk
- Medium risk
- High risk
- Maximum risk
Medical devices classified in risk classes I and II are subject to notification, per Article 6 of the resolution. Medical devices classified in risk classes III and IV are subject to registration, per Article 7 of the resolution.