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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 on 20 August 2020. It […]

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 to secure supply chains and

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

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 licenses to retail medical devices.

The Philippines FDA has announced a virtual consultation on the draft Reference List of Class A Medical Devices and the draft addendum to the Full Implementation of Administrative Order No. 2018-0002 entitled “Guidelines Governing the Issuance of an Authorization for a Medical Device based on the ASEAN Harmonized Technical Requirements”. The PFDA has invited representatives

The Philippines Food and Drug Administration (FDA) recently released a draft for comments on the List of Class A Medical Devices for FDA registration in the Philippines. The List of Class A Medical Devices helps medical device industry stakeholders to determine the appropriate risk classification of their device in order to apply for the correct

The Philippines Food and Drug Administration (FDA) has issued Advisory No.2021-0684: “Guidelines on the process of the issuance of Special Certification of COVID-19 Test Kits” which updates the process of applying for a Special Certification of COVID-19 test kits. In essence, applications for Special Certification for COVID-19 Test Kits, require manufacturers to comply with the

The Philippines Food and Drug Administration (FDA) recently released a draft for comments on an Addendum to FDA Circular 2021-002: Full implementation of FDA Administrative Order No. 2018-00021. FDA Circular 2021-0002 introduced the guidelines for the filing of applications and issuances of Certificates of Medical Device Notification (CMDN) and Certificates of Medical Device Registration (CMDR)

The Philippines FDA has set new performance requirements for the various types of COVID-19 test kits available on the market in the Philippines with immediate effect. The PFDA issued Memorandum No. 2021-009 entitled “Minimum Performance Requirements for COVID-19 Test Kits Used for SARS-CoV-2 Infection” on 23rd March 2021 which applies to test kits seeking marketing