How Long Is the Fee Suspension? Four Rounds and How to Use the Window

1. Key takeaways

AO No. 2024-0016 has been suspended four times: DC No. 2025-0240 for 60 working days, then DC No. 2025-0382 for 60 working days, then DC No. 2025-0574 for 120 working days, and finally DC No. 2026-0329, which extends the suspension by a further 120 working days from June 2026, or until the national energy emergency is lifted, whichever is later. Throughout the suspension, registration, notification, variation and renewal continue to be charged under the old AO No. 50 s. 2001 schedule.

• Four rounds, escalating length: 60, 60, 120 and 120 working days.
• New condition: the fourth round is the first to link expiry to the state of national energy emergency.
• What is suspended: the fee schedule, not the registration obligation itself.
• What is unaffected: preparation, authentication and service costs, which do not move with the policy window.

2. Legal basis

The suspension has been issued as a series of departmental circulars, each superseding the calendar but preserving the earlier provisions that do not conflict with it. The table records the sequence because the operative document at any given time is the latest one, not the most frequently cited one.

3. Expert insights

First insight: suspension is not cancellation, and the direction of travel is a fee increase. The stated reasons across the four rounds were, in sequence: responding to industry feedback and initiating an internal policy review; allowing time for stakeholder consultation and a regulatory impact assessment; completing the fee structure review and finalising internal procedure; and, in the fourth round, linking the deadline to the national energy emergency for the first time. In the March 2026 consultations the FDA stated that the adjustment is intended to support improved regulatory services, including additional staff and training. The policy direction has not reversed; only the timetable has been repeatedly deferred. A manufacturer that reads four suspensions as a signal of retreat is reading the documents against their own text.

Second insight: the fourth round introduces a genuinely new variable. The first three rounds were pure duration extensions. The fourth attaches a condition of whichever is later. The practical window therefore depends on the later of two events, which means two outcomes are open: a further extension, and equally an expiry of the 120 working days without the new schedule coming back into force. Neither can be assumed. Companies should treat the end of the suspension as an event that may occur at short notice, with a defined internal response rather than a general awareness that change is coming.

Third insight: the strategic use of the window is to file core products into it. The practical value is direct: filing under the old fee schedule saves an order of magnitude in official fees. For companies with a product plan covering the next one to two years, the correct response is not to wait and see. The sequence is to inventory the products intended for registration within one to two years and rank them by priority, then file the core products first, meaning flagship products and higher class products, and plan multiple products as a batch submission to reduce unit management cost. What the window saves is official fees, not total project cost: dossier preparation, authentication and service work are unaffected, and that portion does not respond to the policy calendar at all.

Fourth insight: the window is also the economic basis for a fresh registration strategy. This connects directly to articles 19, 32 and 33. During the suspension, the cost of registering afresh through a new holder, rather than negotiating a transfer with the existing holder, falls substantially. That gives manufacturers a realistic exit option in channel negotiations, because the alternative to agreement is no longer prohibitively expensive. Once the window closes, the economics of that strategy deteriorate markedly, and the balance in any negotiation shifts back towards the incumbent holder. The window is therefore not only a cost opportunity but a bargaining position, and it has an expiry date.

4. Practical recommendations

• Manage the suspension as a project event with a review mechanism. Check monthly whether the DOH or FDA has issued a new circular.
• Prioritise higher class products. Under the new schedule Class D rises furthest, so high-risk products gain most from early filing.
• File in batches to reduce unit cost. Plan multiple products together and prepare the documentation in one pass.
• Do not use the suspension as a reason to defer preparation. Dossier work takes time, and starting when the window is nearly closed forfeits both benefits.
• Re-check all affected projects within 72 hours of any new issuance. Treat the publication of a circular as a trigger for a documented impact review.

5. Verification checklist

• □ Current suspension circular identified from the latest DOH departmental issuance
• □ Termination condition confirmed as 120 working days or the lifting of the energy emergency, whichever is later
• □ Schedule applicable during the suspension confirmed as AO No. 50 s. 2001
• □ New schedule amounts confirmed against AO No. 2024-0016 for budget comparison
• □ Core product filing priority set against the internal product list ranking
• □ Monthly review captured in the project calendar with an assigned owner

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support across Southeast Asia, including the Philippines. Our team prepares CMDN/CMDR dossiers to ASEAN CSDT structure, manages submissions and deficiency responses with the FDA Philippines, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com