Registration Fees Compared: The Old Schedule, AO 2024-0016 and the Suspension

1. Key takeaways

Philippine registration fees are in a transition between two schedules. During the suspension the old AO No. 50 s. 2001 applies, under which a five year registration certificate costs approximately PHP 7,575, calculated as PHP 1,515 per year for five years. The new AO No. 2024-0016 schedule sets Class A at PHP 81,000, Class B at PHP 108,000, Class C at PHP 111,000 and Class D at PHP 117,000, all before the 1 percent LRF, but that schedule has been suspended from operation. Whatever the schedule says, the amount actually payable is the one stated on the Order of Payment issued through the eServices portal.

• Two schedules in force: the old one governs payment, the new one governs the amount that will apply once the suspension ends.
• Magnitude of change: the difference is roughly ten to fifteen times, not a modest uplift.
• LRF: 1 percent is added to every fee and is the most frequently omitted line in a budget.
• Evidence: the Order of Payment is the only document that settles a fee dispute.

2. Legal basis

The two schedules, the advisory that confirmed the effect of the new one, the departmental circular that suspended it, and the statute behind the 1 percent add-on are set out below. The amounts are reproduced exactly as published and should be verified against the current issuance before any budget is fixed.

3. Expert insights

First insight: the gap between the schedules is an order of magnitude, with an increase of roughly 10 to 15 times. Under the old schedule a five year certificate costs between PHP 7,500 and PHP 8,000 in official fees. Under the new schedule the same certificate costs PHP 81,000 to PHP 117,000, an increase of more than ten times. The adjustment is presented as bringing fees into line with the cost of regulation; in the public consultation held in March 2026 the FDA explained that the relevant fee structure had not been adjusted for 25 years. For a manufacturer planning a multi-product portfolio, the difference is not a line item but a change in the shape of the market entry budget.

Second insight: several figures circulate for the old schedule, and that is expected rather than alarming. The variants encountered in verification, namely PHP 7,575, PHP 7,625 and PHP 7,915, arise from three sources: whether the 1 percent LRF is included, whether other components are bundled into the total, and different vintages of the source material. GRZAN applies a simple rule: no copied figure is used for budgeting, and the Order of Payment issued through the eServices portal governs. That document is also the only evidence that resolves a fee dispute with the FDA or with a service provider, which is why retaining it matters beyond accounting.

Third insight: the LRF is an easily missed 1 percent. Every fee carries an additional 1 percent Legal Research Fund contribution, grounded in RA No. 3870 as amended by PD 200 and PD 1856. The amount is small in isolation, but under the new schedule it becomes perceptible: Class D at PHP 117,000 carries PHP 1,170. The practical consequence is that any quotation compared against another quotation must state whether LRF is included, because a one percent difference on a large fee is larger in absolute terms than many ancillary charges. The same logic applies to the LTO fee, where the add-on applies to each band.

Fourth insight: three further cost categories sit outside the registration fee. A complete project budget contains government fees, being the registration fee plus the LTO fee; document authentication costs, being notarisation and Apostille; and service costs, being licence holding, consultancy, translation and local testing. During the transition between schedules, government fees are a small proportion of total project cost, and service and authentication costs account for a larger share. This is the sharpest structural difference between the Philippine market today and a market with a settled fee schedule: the cost of a project is driven by preparation and representation rather than by the state. It also means that the fee suspension changes the absolute budget far less than the headline percentages suggest.

4. Practical recommendations

• Budget strictly from the eServices Order of Payment. Do not use fixed figures circulating online, however often they are repeated.
• File core products during the suspension window. This is currently the clearest and most quantifiable cost advantage available.
• Include the 1 percent LRF in every line. Apply the add-on to each fee item rather than to the total only.
• Separate government fees from service costs. Require service providers to itemise quotations so that the two are never blended.
• Run a fee reconciliation. Retain every Order of Payment and compare each against the approved budget at project close.

5. Verification checklist

• □ Current applicable schedule confirmed against the latest DOH departmental circular and FDA advisory
• □ New schedule amounts checked against AO No. 2024-0016, including the LRF treatment
• □ Old schedule amounts checked against AO No. 50 s. 2001, at 1,515 per year for five years
• □ LTO fee band confirmed against the AO No. 50 s. 2001 tiers plus 1 percent LRF
• □ LRF applied at 1 percent to all fee items
• □ eServices Order of Payment obtained and retained as the payment evidence
• □ Suspension status confirmed against DC No. 2026-0329 and any subsequent issuance

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