The Department of Health (DOH) has issued Department Circular No. 2025-0240, temporarily suspending the implementation of Administrative Order (AO) No. 2024-0016 entitled “Implementing Guidelines on the New Schedule of Fees and Charges of the Food and Drug Administration,” in response to feedback and concerns raised by various sectors and stakeholders. Under this directive, the implementation of AO 2024-0016 is suspended effective June 11, 2025, for a period of sixty (60) working days, or until earlier lifted or further extended by the Secretary of Health.
The suspension would take effect seven (7) days after approval by the DOH Secretary as stated in the FDA press release last 29 May 2025, and would remain in force for sixty (60) days.
The suspension seeks to allow time for a comprehensive review of specific provisions of the AO in coordination with the relevant FDA Centers.
To read more, refer to the official announcement and source documents from the DOH:
Department Circular No. 2025-0240 – Full Announcement PDF Document
Effectivity
The temporary suspension of AO 2024-0016 is effective starting June 11, 2025.
Implications to Stakeholders
Stakeholders may experience temporary relief from the increased regulatory fees under AO No. 2024-0016.
Reversion to Previous Fees and Validity Rules
The fee schedule and validity of authorizations under AO 50 s. 2001 and all other previously applicable issuances shall be reinstated and remain in effect. Please refer to the following applicable fees under this circular:
Medical Device Registration | |
Initial Registration
| Php 1,515.00 per year, valid for five (5 years) |
Renewal (CPR, CMDR)
| Php 1,010.00 per year, valid for five (5 years) |
In-Vitro Diagnostic (IVD) Registration | |
Initial Registration
| Php 1,515.00 per year, valid for one (1) year |
Renewal (CPR) | Php 1,010.00 per year, valid for five (5 years) |
Implication to Clients
Clients that have already settled their respective government or registration fees prior to the suspension and/or release of this Department Circular shall retain their payments, which will not be refunded or reallocated.
For applications that have not yet been paid, clients may request a reissuance of the Order of Payment or resubmit their application.
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