RDC 751/2022: Risk classification, the notification and registration regimes, and the requirements for labeling and instructions for use for medical devices.
Resolution – RDC no. 751, of september 15, 2022 was published yesterday (21/09) in the official Gazette of the Union, which provides for risk classification, notification and registration regimes, and labeling and instructions for use of medical devices.
In addition to the changes previously informed by Anvisa and also released by Passarini last week, the new RDC includes new, more up-to-date definitions, thus facilitating the understanding of the requirements established in RDC 751/2022.
RDC 751/2022 enters into force on March 1, 2023, the date on which the following laws will also be repealed:
- I – the Resolution of the Collegiate Board of Directors – RDC No. 185, of October 22, 2001;
- II – Resolution – RE No. 1554, of August 19, 2002;
- III – the Resolution of the Collegiate Board of Directors – RDC No. 207, of November 7, 2006;
- IV – items I and II of article 2, and item II of article 5 of the Normative Instruction – IN nº 4, of June 15, 2012;
- V – the Resolution of the Collegiate Board of Directors – RDC No. 15, of March 28, 2014;
- VI – the Resolution of the Collegiate Board of Directors – RDC No. 40, of August 26, 2015.
Is your company prepared for the changes? Update yourself, access the Portuguese version of RDC 751/2022.
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Passarini Group
Published: 22/08/2022 – Source: Anvisa
