Philippines FDA Extends Fee Suspension: A Critical 60-Day Window for MedTech

The Philippine medical device market has opened a crucial window of opportunity for manufacturers preparing their market entry or renewals.

On September 5, 2025, the Philippines Food and Drug Administration (FDA) issued Department Circular No. 2025-0382, announcing the extension of the temporary suspension on medical device registration fees. This follows the initial suspension granted earlier in the year and underscores the agency’s continued commitment to balancing regulatory modernisation with industry support.

---

The Strategic Opportunity: Continued Cost Savings

This extension provides an additional 60 working days for manufacturers to submit their applications under the current, lower legacy fee structure.

The move comes as the FDA continues stakeholder consultations and internal review of the updated fee schedule proposed under Administrative Order No. 2024-0016. With the revised fees anticipated to be significantly higher, the current extension translates directly into substantial financial advantages for proactive manufacturers.

---

Key Implications for Manufacturers

1. Financial Advantage

Manufacturers can optimise their budgets by finalising submissions during this window, benefiting from the existing lower fees before the new schedule takes effect.

2. Extended Timeline

The additional 60 working days offer a valuable buffer for companies to complete documentation and address technical or administrative requirements.

3. Competitive Market Entry

For firms with ready technical dossiers, this is a strategic moment to accelerate approvals and secure faster market access before costs increase.

---

Regulatory Continuity and Industry Readiness

The extension allows the FDA to finalise internal procedures and address feedback from stakeholders regarding the new fee framework. However, this measure is strictly temporary and will not be extended indefinitely.

Manufacturers are encouraged to treat this period as a final preparation window, ensuring all documentation is compliant and submissions are completed before the suspension expires. Timely action will not only ensure cost efficiency but also smooth alignment with the upcoming regulatory fee structure.

A Balanced Step Toward Modernisation

The FDA’s approach reflects a broader strategy of progressive regulatory modernisation, ensuring transparency, industry participation, and continued access to safe medical devices.

By extending this temporary relief, the agency reinforces its dual priorities: maintaining regulatory rigour while supporting the MedTech sector’s sustainable growth during transition periods.

Source: FDA Philippines