Philippines FDA DC 2025-0382: Extension of Temporary Suspension on Medical Device Registration Fees

Following our previous update on “Philippines FDA Temporarily Suspends Medical Device Registration Fees in 2025” (July 24), the Philippines FDA has issued Department Circular No. 2025-0382 on 5th September, 2025, extending the temporary suspension of medical device registration fees. This extension provides manufacturers with an additional 60 working days to register at the legacy fee rates, offering continued cost savings and a strategic window for market entry.

Background of the Fee Suspension

The FDA initially suspended the increased medical device registration fees under Department Circular No. 2025-0240 for 60 working days starting June 10, 2025. This temporary suspension allowed the agency to conduct stakeholder consultations and internal reviews of the new fee schedule under Administrative Order No. 2024-0016.

Extension Under DC No. 2025-0382

Considering ongoing consultations and internal review, the FDA has extended the suspension for an additional 60 working days. This extension begins immediately after the initial suspension period, allowing the FDA sufficient time to finalize internal processes and address stakeholder concerns while maintaining the opportunity to register at the old fee rates.

Key Takeaways for Manufacturers

• Continued Cost Savings: Manufacturers can register medical devices at the legacy rates, which are significantly lower than the new fees.

• Extended Timeline: The suspension now lasts an additional 60 working days after the initial period.

• Strategic Opportunity: Ideal for manufacturers planning registrations or renewals in the Philippines.

Next Steps

Manufacturers should act promptly to take advantage of the extended suspension. Initiating registration during this period maximizes cost savings and avoids the higher fees once the suspension ends.

For full details on the extension, review the official Department Circular No. 2025-0382.

Conclusion

Philippines FDA issued Department Circular No. 2025-0382, extending the temporary suspension of 2025 medical device registration fees for an additional 60 working days. This follows the initial suspension under DC No. 2025-0240 and allows manufacturers to continue registering at legacy fee rates. The extension ensures sufficient time for stakeholder consultations and internal review, providing cost savings and strategic registration opportunities.

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