RDC 751/2022 comes into force tomorrow, March 1, 2023

RDC 751/2022 comes into force tomorrow, March 1, 2023

RDC 751/2022, which provides for risk classification, notification and registration regimes, and labeling requirements and instructions for use of medical devices, enters into force tomorrow, March 1, 2023.

With the publication of RDC 751/2022, several changes were made to the regulation of medical devices, including:

• Change of some definitions and inclusion of definitions that are in accordance with the current context, facilitating the understanding of the legislation.
• Inclusion in the legislation of the reasons why the issuance of technical demands will not be subject to.
• Inclusion in the legislation of the acceptance of documents in Portuguese, Spanish or English.
• For medical device registration (III and IV), it will be necessary to send a registration form, which is available on Anvisa’s electronic portal.
• Possibility of stock depletion of finished products due to change to class III and IV products.
• Permission to run out of stock of packaging, labels and instructions for use for a period of 120 days from the publication of the change.
• Change of some classification rules.
• Inclusion of specific classification rules for some types of medical devices, including software as a medical device (SaMD) and devices incorporating nanomaterials.
• Establishment of a period of 365 (three hundred and sixty-five) days, counting from March 1, 2023, for the holders of medical device notifications to file petitions for sanitary reclassification of products that had their notification regime modified for registration.

With the entry into force of RDC 751/2022, the following legislation will be revoked:

I – Resolution of the Collegiate Board of Directors – RDC nº 185, of October 22, 2001;
II – Resolution – RE No. 1554, of August 19, 2002;
III – 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 Normative Instruction – IN No. 4, of June 15, 2012;
V – Collegiate Board Resolution – RDC No. 15, of March 28, 2014;
VI – Collegiate Board Resolution – RDC No. 40, of August 26, 2015.

Is your company prepared for the changes? Update yourself, access the English version of RDC 751/2022.

Count on us in this update. Our team of experts is available for any clarification.

But if you still have doubts, talk to our specialists via email: contato@passarini.com.br.

Passarini Group

Published: 03/28/2023 – Fonte: Anvisa