Philippines Philippines publishes draft on mercury regulation for medical devices

Thermometers, sphygmomanometers and dental restorative materials are covered

On July 14, 2021, Food and Drug Administration (FDA) of the Philippines published a draft circular entitled “Banning of all Mercury-Containing Thermometers, Sphygmomanometers, Dental Amalgam Capsules and Liquid Mercury for Use in Dental Restorative Purposes”. This circular is intended to completely ban the manufacture, distribution, importation, exportation, sale, offer for sale, donation, transfer, use, promotion, advertising, and sponsorship of mercury-containing thermometers, sphygmomanometers, dental amalgam capsules and liquid mercury for use in dental restorative purposes in order to prevent health hazards caused by mercury.

As transitional measures, this draft circular allows authorized distributors and retailers of dental amalgam capsules to sell the remaining stocks in the market until June 6, 2023. On the other hand, the grace period for mercury-containing thermometers and sphygmomanometers is 30 days from the effective date of this circular.

The original text of this draft circular is available at the following URL.
https://www.fda.gov.ph/draft-for-comments-of-banning-of-all-mercury-containing-thermometers-sphygmomanometers-dental-amalgam-capsules-and-liquid-mercury-for-use-in-dental-restorative-purposes/