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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

The Philippines FDA issued Circular no. 2021-002 on Monday 4th January 2021, which contains the implementation scheduleof the Administrative Order No 2018-002: “Guidelines Governing the Issuance of an Authorization for a Medical Device based on the ASEAN Harmonized Technical Requirements” over three (3) phases. Administrative Order (AO) no. 2018-002 section IX stipulates that the requirement of registration for all medical

The Philippines Food and Drug Administration (FDA) has resumed access to its online Verification Portal which provides comprehensive lists of FDA Licensed Establishments and Registered Health Products. The portal is open access so that the general public can verify whether a medical device placed in the Filipino market is properly licensed and distributed by an authorized dealer. The portal was