Last 15th September, ANVISA (Agência Nacional de Vigilância Sanitária), the Regulatory Authority of the Medical Devices and IVD market in Brazil, by publishing RDC 751/2022 introduced significant updates to RDC 185/2001, which deals with market access and registration requirements for Medical Devices. These amendments will enter into force on 1st March 2023.
The new text aligns with Mercosur’s GMC Resolution No. 25/2021, which, on Brazil’s initiative, updates the documentation requirements and classification rules for Medical Devices applicable in the single market region.
In general, the Brazilian Resolution RDC 751/2022 defines rules for risk classification, labelling requirements, instructions for use and procedures for the notification or registration of Medical Devices.
Here are the most significant changes introduced by the measure:
- specific classification rules for new technologies, such as software as a Medical Device (SaMD) and nanomaterials;
- unification of notification, registration and amendment rules;
- mandatory inclusion of Instructions for Use (IFU) in the Medical Device Documentary File, as well as related label information, also in electronic format;
- Inclusion of the definition of Brazil Registration Holder (BRH), previously defined as “Importer”. Manufacturers will have to include the new wording for Local Representative on IFUs and labels after 1st March 2023;
- IFU, labels and application forms to ANVISA must be submitted in Portuguese; other documents may be provided in English;
- Rules on advertising.
The above changes do not affect In Vitro Diagnostic Devices, nor do they affect refurbished or customised Medical Devices.
In an era where change is a new constant, it is of crucial importance that operators in the sector are aware of the new rules applicable to Medical Devices already present in the Brazilian domestic market, so that they can develop their activities in a safe and effective way, aligned with best practices from a regulatory perspective.
>>>Do you need support to market your Medical Devices in Brazil?
Rely on Thema’s experts to prepare a Feasibility Analysis and document pre-screening as part of the strategic-regulatory consulting service. As follows, Thema can assist you in registering your devices with ANVISA and provide BRH support to make your organisation completely independent from the Importer/Distributor on site.
Contact us for more info!
