The regulation of medical products and devices is essential to ensure safety and efficacy in healthcare. In this context, the National Health Surveillance Agency (ANVISA) published Collegiate Board Resolution (RDC) No. 923 on September 19, 2024, which introduces important guidelines for the commercialization and labeling of dental whitening agents. The new resolution reflects ANVISA’s commitment to health safety, revoking previous regulations and establishing specific penalties for non-compliance with the new guidelines. This article analyzes the implications of this resolution for healthcare professionals in detail.
RDC No. 923, September 19, 2024
RDC No. 923, dated September 19, 2024, defines the criteria for the packaging, labeling, and commercialization of dental whitening agents classified as medical devices.
Medical devices intended for dental whitening containing more than 3% hydrogen peroxide, either present or released, require a prescription from a qualified professional in the form of a simple prescription. The commercialization of these products must be directed to qualified professionals and dental service companies, with the presentation of the Professional Council registration, including the registration number on the transaction’s fiscal document.
Dental whitening agents, on their packaging and labeling, must prominently display, in a red stripe, the expression “Sale by Prescription Only.”
In addition, the labeling must include the concentration of hydrogen peroxide, whether present or released from other components or mixtures thereof.
Failure to comply with these provisions of the Resolution may result in sanitary penalties, as per Law No. 6,437/1977, without prejudice to applicable civil, administrative, or criminal penalties. The regulation revokes RDC No. 6/2015 and is already in effect.
📝 Access RDC 923/24
The original language version of this announcement is the authorized official version. Translations are provided as a convenience and should refer to the original language text, which is the only version with legal effect.
Click the link to access the Original Version
For questions, contact Brisa Advisors for specialized regulatory support.
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