Countdown! Philippines PFDA Medical Device Registration Price Increase Window Closes on November 20
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Time:2026-10-20 11:01:22


The Department of Health (DOH) of the Philippines issued Department Circular No. 2026-0329. The circular specifies that the temporary suspension of Administrative Order (AO) 2024-0016’s new fee schedule shall be extended for another 120 working days, or until the lifting of the State of National Energy Emergency under EO No.110, whichever is longer. Market calculation estimates the suspension window will end on 20 November 2026, marking a one-month countdown to the expiry of this window.



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https://www.fda.gov.ph/administrative-order-implementing-guidelines-on-the-new-schedule-of-fees-and-charges-of-the-food-and-drug-administration/

一、Comparison of Registration Fees (Old vs New)



During the suspension period, PFDA medical device registration continues to follow the original fee framework. Once the suspension window expires, all registration applications will adopt the new fee schedule stipulated under AO 2024-0016, resulting in a substantial rise in registration costs.


Device ClassificationExisting Fee (Certificate Valid for 5 Years)New Fee Schedule (Certificate Valid for 6 Years)
Class A7,575.00 PHP81,810.00 PHP
Class B7,575.00 PHP109,080.00 PHP
Class C7,575.00 PHP112,110.00 PHP
Class D7,575.00 PHP118,170.00 PHP

Note: The existing fee includes a 1% LRF surcharge. The new fee schedule also includes the 1% LRF. The validity period of the certificate is extended from 5 years to 6 years, yet the one-time registration cost rises sharply. Fee data is sourced from Annex D of AO 2024-001 (CDRRHR Fee Schedule for Medical Devices).
二、Regulatory Provisions & Enterprise Risk Warnings



(一)Submission ≠ Lock-in of Old Fees

Even if a registration application is submitted before 20 November 2026, there is no guarantee the old fee rate will apply. Under PFDA rules, the applicable fee is determined based on the official implementing guidelines and the payment acceptance date of each individual application case, not the document submission date. Enterprises cannot rely solely on filing before the deadline to secure the lower fee.


(二)Possibility of Further Extension of Suspension
Department Circular DC 2026-0329 states that the suspension period is 120 working days or the date when the State of National Energy Emergency under EO No.110 is lifted, whichever is longer. This means that if EO No.110 State of National Energy Emergency remains in force after 20 November, the new fee schedule will remain automatically suspended. Final implementation of the new fees is subject to subsequent official circulars released by Philippine DOH/PFDA.

(三)Transition Implementation Rules
Before the new fee schedule formally takes effect, PFDA medical device registration continues under the old fee framework AO 50 s.2001. Upon termination of the suspension status, all newly submitted registration applications will switch to the full fee rules under AO 2024-0016.
三、Recommended Actions for Manufacturers Exporting Overseas



Medical device enterprises planning to enter the Philippine market are recommended to immediately review their product registration roadmap:
  • Evaluate product classification and calculate cost differences between old and new schemes;
  • Organize registration documents, prepare technical files in advance and reserve sufficient review lead time;
  • Continuously monitor official announcements published in the CDRRHR section on PFDA official website for policy updates;
  • Reasonably schedule registration timelines to mitigate cost and cycle risks arising from policy changes.
四、Closing Remarks



Medical device manufacturers intending to establish presence in the Philippine market are advised to assess product registration plans as soon as possible, organize document preparation progress and schedule registration activities in advance. Keep track of follow-up PFDA official announcements to respond promptly to cost and timeline changes brought by policy adjustments.For further enquiries, feel free to contact Wiselink!

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