Philippines’ Department of Health (DOH) has released various administrative orders (AO) for phasing out mercury and related products the past years (AO 2008-2021, AO 2020-0020). Despite these regulations, the selling of products with mercury still exists in the market.
The recently issued FDA Circular No. 2022-003 yet aims for the total ban of specific mercury-added medical devices and related products, and addresses the limitations of the preceding policies covering the same. In recent events, numerous digital platforms have been used for their marketing, which were not covered by the said preceding policies.
The following are the summarized key-point guidelines of the circular:
- The manufacture, distribution, importation exportation, sale, offer for sale, donation, transfer, promotion, advertising, sponsorship, use of digital platforms for marketing purposes and other involved establishments related to mercury-added thermometers, sphygmomanometers, liquid mercury, and dental amalgam capsules for dental restorative purposes, including newly produced/stocked/second-hand products, are prohibited.
- The manufacturer, trader, distributor, importer, exporter, and wholesaler of mercury-added thermometers and sphygmomanometers shall be responsible to conduct an inventory of stocks and recall off their products to ensure that it should no longer be available to the market.
- The storage, transport, and disposal of these banned medical devices shall comply with the existing implementing rules and regulation of the Department of Environment and Natural Resources (DENR).
- Medical devices containing mercury that do not have an effective alternative and/or considered as gold standard that are used in the laboratory are not cover in the circular.
PFDA Bans Medical Device with Mercury