Patient safety is one of the cornerstones of healthcare. The National Health Surveillance Agency (ANVISA), as the regulatory body responsible for public health, plays a key role in ensuring the quality and safety of health products. RDC No. 924/2024, by establishing new labeling rules for medical devices that contain latex, demonstrates ANVISA’s commitment to protecting the health of Brazilians. The new regulation contributes to the prevention of severe allergic reactions and promotes safer healthcare practices.
This article provides an in-depth analysis of the implications of these resolutions for healthcare professionals.
RDC No. 924, September 19, 2024
RDC No. 924, dated September 19, 2024, establishes standardized phrases for labeling medical devices containing natural rubber latex.
The regulation mandates that the labels of such products must prominently display the standard phrase: “CONTAINS NATURAL LATEX. MAY CAUSE ALLERGY,” and prohibits the use of the term “hypoallergenic.”
It is optional to use the phrase provided in Section V, Article 8 of RDC No. 825/2023 for surgical gloves and non-surgical procedure gloves made of natural rubber, synthetic rubber, mixtures of both, and polyvinyl chloride, under sanitary surveillance. Additionally, a symbol identifying the presence of latex is allowed, according to ABNT NBR ISO 15223-1:2022, and must be accompanied by the phrase “MAY CAUSE ALLERGY.”
It is important to note that this resolution applies to a wide range of medical devices, including those for in vitro diagnostics, and establishes that non-compliance with these rules constitutes a sanitary infraction, subjecting the responsible party to penalties. The regulation revokes RDC No. 37/2015 and is already in effect.
📝 Access RDC 924/24
The original language version of this announcement is the authorized official version. Translations are provided for convenience and should refer to the original language text, which is the only legally binding version.
Click the link to access the Original Version
For any questions, contact Brisa Advisors for specialized regulatory support.
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