REGULATORY UPDATE | The FDA Philippines Prohibits Dental Restorative Use of Sphygmomanometers, Dental Amalgam Capsules, Mercury Thermometers, and Liquid Mercury

On June 10, 2022, the FDA Philippines issued a circular prohibiting the use of medical devices containing mercury, including mercury thermometers, mercury sphygmomanometers, dental amalgam capsules, and liquid mercury for dental restorative purposes. According to the World Health Organization (WHO), mercury is classified as one of the top ten chemicals of major public health concern. Even small amounts of mercury exposure can lead to serious health issues, particularly affecting a child's development both in utero and during early life. Medical devices that contain mercury pose risks, including thermometers, sphygmomanometers, digestive devices, and dental amalgams.

In the circular, the FDA Philippines stated that it prohibits the manufacture, import, export, distribution, sale, donation, transfer, and, where applicable, promotional, advertising, or sponsorship activities related to mercury-added thermometers and sphygmomanometers used in dental restorative practices. This measure aims to protect public health from the adverse effects associated with mercury-containing medical devices. The FDA is tasked with safeguarding public health and safety through effective regulation of medical devices in the Philippines. This circular also addresses the rising concerns about the rampant sales of mercury-added medical devices on various digital platforms and seeks to completely ban such devices in the country.

PRODUCT RECALL

The FDA Philippines is restricting the sale of used mercury-added thermometers and sphygmomanometers. Manufacturers, traders, distributors, importers, exporters, and wholesalers are responsible for conducting stock inventories and recalling their products to ensure that all mercury-added thermometers and sphygmomanometers are removed from the market. Companies found violating the provisions stipulated in Republic Act No. 9711 and its Implementing Rules and Regulations (IRR) will face sanctions and penalties.

For more details, please refer to the original source: FDA Circular No. 2022-003 || Banning of all Mercury-Added Thermometers, Sphygmomanometers, Dental Amalgam Capsules, and Liquid Mercury for Use in Dental Restorative Purposes – Food and Drug Administration.

Read more at the original source: FDA Circular No.2022-003 || Banning of all Mercury-Added Thermometers, Sphygmomanometers, Dental Amalgam Capsules and Liquid Mercury for Use in Dental Restorative Purposes – Food and Drug Administration