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Philippines FDA Bans Mercury-Added Products
Published on: June 27th, 2022
Mercury-Added Thermometers, Sphygmomanometers, and Dental Products Now Banned
Released on June 13, 2022, the Philippines FDA released FDA Circular No.2022-003 banning the manufacture and sale of mercury-added products including thermometers, sphygmomanometers, dental amalgam capsules and liquid mercury for use in dental restorative purposes. Following this announcement, all specified mercury-added products must cease to be marketed, sold, and/or imported, including second hand products already on the market. Offering any of these products for sale online or through social media is strictly prohibited and could face penalties.
These regulations were initially set into motion in 2008 with the release of AO No. 2008-0021 entitled “Gradual Phase-out of Mercury in all Philippine Health Care Facilities and Institutions.” In accordance with AO No. 2008-0021 and the more recently released AO 2020-0020, the Philippines FDA will cease to accept any new applications or issue any authorizations 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.
Per FDA Circular No.2022-003, the following products may no longer be sold on the Philippines market:
- Clinical Mercury Thermometer – a device used to measure oral, rectal, or axillary (armpit) body temperature using the thermal expansion of mercury.
- Dental Amalgam (commonly known as “silver fillings”) – used to repair decayed or broken teeth generally made up of mercury, silver and tin, with small amount of copper and zinc.
- Dental Amalgam Capsule – a capsule that contains silver alloy, mercury, a pestle and a plastic bubble.
- Mercury sphygmomanometer – manual device for measuring blood pressure (BP), composed of an inflation bulb for controlling the air pressure in the cuff which is attached to a measuring unit and a mercury-infused glass column which displays BP (values in mm Hg).
Removing Mercury-Added Products from the Market
Manufacturers, distributors, importers, and re-sellers will need to check their inventory for mercury-added devices and take the necessary steps to remove or recall these products from the market and ensure their not available moving forward. Storage, transportation, and disposal of these newly banned medical devices will need to comply with the existing implementing rules and regulations of the Department of Environment and Natural Resources (DENR).
Any entity found to be in violation of Circular No. 2022-003 shall be subjected to sanctions and penalties as prescribed under RA 9711 and its IRR.
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Please contact us if you have questions regarding the new regulations and/or are interested in registering your product in the Philippines. Asia Actual specializes in helping medical device manufacturers grow their sales in Asia with experienced, bi-lingual commercial and regulatory experts on the ground in each market. Contact Asia Actual today with any questions or support requests.
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