Charmaine Roson - Philippines

“Manufacturers and distributors should consider their inventory and products on the market to ensure applicable products have been removed from the market.”

Charmaine Roson
Principal Consultant
Asia Actual Philippines

Come grow with us in the US in Thailand in China in Korea in the Philippines in Taiwan in Hong Kong

Sources and Links

Sign Up For Our Newsletter to Stay Informed

Sign Up

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.

Affected Products

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.

Grow With Us

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.

Asia Actual is a regulatory consulting company specializing in helping manufacturers grow their sales through independent license holding, direct fulfillment, and a variety of sales channel support services.

Blog Posts

CDSCO Issues Updates to IVD Classification List in India

The Central Drugs Standard Control Organisation (CDSCO) of India issued a notice (PDF) on October 25, 2023 classifying in-vitro diagnostic (IVD) medical devices under medical device rules. The updates to IVD classification in India include intended use, associated risk, and other parameters.
Read more

Embracing Innovation and Collaboration: Highlights from the 15th CII Global MedTech Summit

On October 6, 2023, a team of enthusiastic members from the AAI (Artificial Intelligence and Innovation) group, including Ashoniya Puri, Sanjay Singh, and Rajat Budhori, had the honor of attending the prestigious 15th CII Global MedTech Summit. Hosted by the Confederation of Indian Industry (CII), one of India's largest industry bodies, this event brought together key players in the MedTech sector, both from India and abroad. The summit revolved around the central theme, "Paving the way for a USD 50 billion MedTech Industry by 2030," signifying a collective vision for the industry's future growth.
Read more

Bangladesh LAUNCHES NEW MEDICAL DEVICE REGULATIONS

On September 18, 2023, The Directorate General of Drug Administration (DGDA) published the Drug and Cosmetics Act 2023 formalizing the regulatory requirements of medical and diagnostic devices in Bangladesh with immediate effect.  A translated version of the document is available on Asia Actual’s website here.  All medical devices now require a Marketing Authorization Certificate to clear Customs and be sold on the market in Bangladesh.
Read more