Parent using a mercury based thermometer to check their child's temperature

Philippine FDA Has Announced A Notice For Banning Of All Mercury-added Thermometers, Sphygmomanometers, Dental Amalgam Capsules And Liquid Mercury For Use In Dental Restorative Purposes

FDA Circular No.2022-003
MARKETING AUTHORIZATION & DISTRIBUTION/OFFER FOR SALE

 

The Philippine Food and Drug Administration (FDA) has announced a notice to the public regarding the banning of all mercury-added thermometers, sphygmomanometers, dental amalgam capsules and liquid mercury for use in dental restorative purposes.

 

This Circular aims to totally ban the manufacture, importation, exportation, distribution, sale, offer for sale, donation, transfer, and where applicable, the use, promotion, advertising, or sponsorship of mercury-added thermometers and sphygmomanometers along with dental amalgam capsules and liquid mercury for use in dental restorative purposes to protect human health from the adverse effects of mercury-added medical devices.

This Circular shall cover establishments that are engaged in the manufacturer, distribution, importation, exportation, sale, offer for sale, donation, transfer, and where applicable, the use, promotion, advertising, or sponsorship of mercury-added thermometers and sphygmomanometers along with dental amalgam capsules and liquid mercury for use in dental restorative purposes.

This issuance shall not cover medical devices containing mercury that as of the moment do not have effective alternative technology and/or considered gold standard that are used in the laboratory to test the accuracy of similar medical devices. Such similar medical devices are considered alternate to the gold standard mercury containing medical device.

Summary of Guidelines

  • The manufacture, distribution, importation, exportation, sale, offer for sale, donation, transfer, and where applicable, the use, promotion, advertising, or sponsorship of mercury-added thermometers and sphygmomanometers are strictly prohibited.
  • Offering for sale and/or sale of mercury-added thermometers and sphygmomanometers through different digital platforms including social media or through online shopping platforms is strictly prohibited.
  • The importation, distribution, sale or offer for sale of liquid mercury and dental amalgam capsules for use in dental restorative purposes shall not be allowed.
  • Following AO 2020-0020 and AO 2008-0021, FDA shall not be accepting any application nor shall issue any authorization for the manufacture, distribution, importation, exportation, sale, offer for sale, donation, transfer, and where applicable, the use, promotion, advertising, or sponsorship of liquid mercury and dental amalgams for use in dental restorative purposes, mercury-added thermometers and sphygmomanometers.
  • Offering for sale and/or sale of second-hand mercury-added thermometers and sphygmomanometers are likewise strictly prohibited.
  • It shall be the responsibility of the manufacturer, trader, distributor, importer, exporter, wholesaler to conduct inventory of stocks and recall of their products to ensure that all mercury-added thermometers and sphygmomanometers are removed from the market and ensure that such products shall no longer be made available to the market.
  • The storage, transport, and disposal of these banned medical devices shall comply with the existing implementing rules and regulations of the Department of Environment and Natural Resources (DENR).
  • This Circular shall take effect fifteen (15) days following its publication in the Official Gazette or in a newspaper of general circulation and upon filing three (3) certified true copies with the University of the Philippines Law Center – Office of the National Administrative Register.

You can read about it in full here.

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