The FDA Circular No. 2021-021, which took effect on 18 December 2021, was issued to provide guidelines on the licensing of retailers of medical devices in the Philippines, as well as acting as a supplement for the previously issued Administrative Order (AO) No. 2020-0017 regarding the simplification of the requirements and processes for initial, renewal, and variations of LTO (License to Operate) applications for health products, including retailers of medical device. Section IX of the FDA 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 will end on 18 December 2023. To improve the current workflow, the FDA is still updating its processes by migrating the online licensing application process from the ePortal System to the eServices Portal System for medical device manufacturers. Given this, the FDA Circular No. 2021-021-A was then issued on 26 March 2024 to provide clearance on the amended transitory provision, as mentioned below:
- The filing of LTO variation application of FDA-licensed manufacturers that sell or intend to sell medical devices directly to the general public will be extended until the migration of the online licensing application has been completed for the said establishments.
- FDA-licensed traders or distributors 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 eServices Portal System (https://eservices.fda.gov.ph/), are given until June 30, 2024 to secure the approval of the said LTO variation; after which selling of medical devices directly to the general public by the said establishments without securing the amended LTO shall be prohibited.
The FDA Circular. No. 2021-021-A will take effect within fifteen (15) days after its publication in the official gazette or in any newspaper of general circulation and upon filing with the University of the Philippines Law Center of the National Administrative register.
Further information on the FDA Circular can be accessed here.
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