Regulatory Affairs Update: Philippines

Philippines: Extension of Transition Period for Licensing of Retailers of Medical Devices

The Philippines’ Food and Drug Administration (FDA) previously issued FDA Circular No. 2021-021, supplementing the Administrative Order (AO) of the Department of Health No. 2020-0017, which took effect on 18 December 2021. Section IX of the said Circular stated that all retailers should be given 2 years from the circular’s effectivity to comply with its provisions. Based on the Circular, the transitory period ended on 18 December 2023.

In this FDA Advisory No. 2024-0539, it was stated that all concerned retailers were advised to secure a License to operate (LTO) from the FDA. The FDA-licensed traders or distributors (importers, exporters, and/or wholesalers) of medical devices that sell or intend to sell directly to the general public may apply for variation (additional activity) of their existing LTO through the eService Portal System (

The transitory provision for FDA-licensed medical device manufacturers that sell or intend to sell directly to the general public is hereby extended until the migration of the online Licensing Application process from the ePortal System to the eServices Portal System has been completed.

All concerned entities, such as manufacturers, importers, exporters, sellers, offering for sale, distributors, transferees, or retailers, are prohibited from manufacturing, importing, exporting, selling, offering for sale, distributing, transferring, or retailing any health product, including medical devices, without LTO from the FDA are prohibited.

More information on the FDA circular can be accessed here. This FDA circular takes effect from 22 March 2024.

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