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GPC - Global Product Compliance

Resolutions for Brazilian Medical Devices

2022-05-04 Reference source : GMPs, MERCOSUR, SaMD

Brazil Regulatory update medical devices

According to notifications from World Trade Organization (WTO), several resolutions for medical devices are proposed to enter into force with the earliest start being on May 2, 2022, by the Brazilian Health Regulatory Agency. Earlier in March 2022, Brazilian Health Regulatory Agency (ANVISA) announced a few regulations regarding technical requirements and defined criteria for medical devices.

In alignment with International Medical Device Regulators Forum (IMDRF) and its issued document IMDRF/RPS WG/N9 (Edition 3), ANVISA has also provided resolutions focusing on regularizing the software-form of medical devices (Software as a Medical Device - SaMD). Another resolution is issued on hardware medical devices including in vitro diagnostic products and the Good Manufacturing Practices (GMPs) required are issued and further incorporated into the MERCOSUR system.

Resolutions aforementioned are mostly expected to start from May 2, 2022, with no applicable final date for comments; whereas resolution for SaMD (i.e. Resolution - RDC number 657) is scheduled to be adopted from July 1, 2022.


We acknowledge that the above information has been compiled from GMPs, MERCOSUR, SaMD .