Philippines FDA consultation on ban of mercury-containing thermometers
The Philippines Food and Drug Administration (FDA) has extended the date for comments on a draft Circular on Banning all Mercury-Containing Thermometers, Sphygmomanometers, Dental Amalgam Capsules and Liquid Mercury for Use in Dental Restorative Purposes. Comments may be submitted until 14 August 2021.
This draft circular follows guidelines issued in May 2020 by the Department of Health Administrative Order No.: 2020-020 on phasing out mercury use in dental restorative procedures and the signing of the Minamata Convention on Mercury on 02 June 2020 to protect the environment and human health from the effects of mercury.
The draft Circular concerns the following products:
- mercury-containing thermometers and sphygmomanometers,
- dental amalgam capsules
- liquid mercury used in dental restorations.
The draft Circular aims to ban the following:
- sale/offer for sale (including through digital platforms including social media or online shopping platforms),
The proposed legislation will not affect medical devices containing mercury that presently do not have effective alternative technology and/or are considered the gold standard used in laboratory settings to test the accuracy of similar medical devices.
Implications for manufacturers, distributors, importers, exporters, wholesalers:
The manufacturer, trader, distributor, importer, exporter, wholesaler must undertake an inventory of stock and recall of any concerned products to ensure that all mercury-containing thermometers and sphygmomanometers are removed from the market.
All concerned parties must comply with existing rules and regulations of the Department of Environment and Natural Resources (DENR) regarding the storage, transport, and disposal of these banned medical devices.
For dental amalgam capsules
Authorized distributors and retailers shall be given until 06 June 2023 to exhaust remaining stocks in the market. After which the distribution, offer for sale and sale of such products shall no longer be allowed.
For thermometers and sphygmomanometers containing mercury including liquid mercury
Authorized distributors and retailers shall be given a grace period of thirty (30) days from the effectivity of this Circular to comply with the provisions of this notification. The Circular shall be effective fifteen (15) days after its publication in a newspaper of general circulation and upon acknowledgement of receipt of a copy hereof by the University of the Philippines – Office of the National Administrative Register.
How to submit your comments:
All comments can be sent directly to [email protected] . The deadline for the submission of comments is 14 August 2021. Andaman Medical clients may send us any issues they wish highlighted via the consultation. To do so please send an email entitled Philippines FDA Consultation on Mercury Containing Thermometers to the Regulatory Affairs Specialist in charge of your dossier with the following information:
- Your name and job title
- Company’s name
- Email address
- Name of the product that is currently registered in the Philippines or that you wish to register in the future and is affected by the proposed draft
- Your comments about the draft proposal.
To learn more about registering medical devices in the Philippines click here.
To learn more about the medical device market in the Philippines click here.
We can register and import your medical device into the Philippines. Contact our sales team to find out more by clicking on the button below.