Regulatory Updates

The Philippines Food and Drug Administration (FDA) has issued a second amendment to its guidelines on FDA-issued authorizations due to the ongoing global pandemic and community quarantine requirements. FDA Circular 2020-024 entitled “Updated guidelines for applications of authorizations with the FDA in light of community quarantine declarations” was first issued

During the COVID-10 pandemic a list of essential medical devices was drawn up as they were deemed essential for public health in combatting Coronavirus. These products also had a mandatory price ceiling fixed. The Philippines government has since decided to extend this measure to medical devices in general in order

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

The Philippines FDA (Food and Drug Administration) has published a draft version of “Guidelines on the Licensing of Retailers of Medical Devices in the Philippines”.  This draft is now open for comments from concerned parties until 24 July 2021. The draft guidelines specify those establishments that are required to obtain