Philippines FDA, Increases Medical Device Registration Application Fees

 

On December 9, 22024, the Philippines FDA announced Implementing Guidelines on the New Schedule of Fees and Charges of the Food and Drug Administration under Administrative Order No. 2024-0016.

 

For the past 20 years, the FDA’s fees and charges were based on Administrative Order No. 50s, 2001. However, due to recent technological advancements and the development of the health products industry, the FDA has implemented corresponding fee and charge increases to ensure the provision of efficient services.

The regulation is yet to be officially published and will take effect 15 days after its official publication.

 

The increased medical device registration fees are as follows:

Item	Initial Application Fee (per year in PhP)
LTO (License to Operate) for Distributors (Importers, exporters, wholesalers)	8,500
Class A : Certificate of Medical Device Notification	13,500
Class B : Certificate of Medical Device Registration	18,000
Class C : Certificate of Medical Device Registration	18,500
Class D : Certificate of Medical Device Registration	19,500
CIVDR Class A Registration	13,500
CIVDR Class B Registration	18,000
CIVDR Class C Registration	18,500
CIVDR Class D Registration	19,500

 

Please refer to the attaced document below. 

ao2024-0016.pdf

1.36MB

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