Brazil Market Update: Amendments to RDC No. 751/2022 on Medical Device Registration and Notification

Brazil’s national health surveillance agency ANVISA has published RDC No. 777/2023. The resolution amends The Collegiate Board Resolution – RDC 751 of September 15, 2022, which provides for the classification of risk, notification and registration regimes and the requirements of labeling and instructions for the use of medical devices.  RDC No. 777/2023 provides the following amendments and clarifications (link in Portuguese) to RDC No. 751/2022 on medical registration and notification, effective March 1, 2023:

• Non-applicability of RDC 751/2022 to customized medical devices according to Article 2 (§ 3)
• Correcting reference to Normative Instruction No. 74/2020 published in DOU No. 180 on September 18, 2020 (Article 16)
• Removal of the deadline in Article 22 for uploading documents to ANVISA’s electronic portal after the publication of “changes for immediate implementation” in the Official Gazette
• Revision to Article 9 on identifying the cases for suspension of certain activities
• Revoked Article 40 relating to the publication of suspension of activities in the Official Gazette
• Irregular medical device registrations are also subject to ANVISA’s procedure of requesting or Medical Device Registration – Brazil ANVISA clarifying information prior to cancellation of registration
• Condition of applicability of the “general summary of clinical evidence” requirement in Annex II, Chapter 4 highlighted for Class I and II devices

Our previous coverage of RDC 751/2022

You may want to review our previous coverage of RDC 751/2022.

First, take a look at what has changed between RDC 185/2001 and RDC 751/2022 in terms of medical device labeling requirements.

Second,  let’s examine how grouping is pivotal to regulatory strategy as it determines how devices can be authorized in a regulatory submission.

Third, review how, effective March 1, 2023, the technical dossier must be structured as described in Brazilian medical device regulation RDC 751/2022.

And lastly, read about how Brazilian regulators have aligned medical device classification rules to those of EU MDR.

Emergo by UL will post updates as they become available.