The Food and Drug Administration (FDA) of the Philippines has issued Administrative Order No. 2024-0016, introducing updated guidelines for fees and charges for its services. This significant update aligns regulatory costs with modern industry demands and provides clarity for stakeholders, particularly foreign heath product manufacturers and regional distributors seeking to import their products into the Philippines. Below, we explore the key aspects of this new administrative order with a focus on medical devices, and its implications for the healthcare import sector.

Administrative Order No. 2024-0016 introduces a long-overdue revision to the fee structure, replacing the outdated AO No. 50 s. 2001. This update ensures the FDA can address modern regulatory demands while supporting foreign manufacturers and distributors.

Key Updates and Specific Guidelines

1. Fees for Product Authorizations

The fees for medical device product applications are outlined in the table below.

Device Class (General or IVD)	Applicable Fees (PHP, inclusive of Legal research fee, LRF)
	Initial Registration	Renewal	Minor Variation	Major Variation
Class A Devices	81,810	6 years: 92,718 12 years: 185,436	3,030	4,040
Class B Devices	109,080
Class C Devices	112,110
Class D Devices	118,170

Other details:

• The certificates now have an initial validity of 6 years, with the option to renew for up to an additional 6 or 12 years, depending on the applicant's preference.
• PFDA is yet to release further guidelines on the scope of minor and major variation.

 

2. Establishment License/License to Operate (LTO) Transactions

For establishments engaged in the manufacture, distribution, importation, or retail of medical devices, below is the updated annual fees for LTO transactions:

Transaction Type	Applicable Annual Fees (PHP, inclusive of Legal research fee, LRF)
	Initial Application	Renewal	Minor Variation	Major Variation
Manufacturer (Low Risk)	31,209	31,209	1,616	13,332
Manufacturer (Medium to High Risk)	51,308	51,308
Distributor (Importer, Exporter)	8,585	8,585
Retailer	3,030	3,030	630	3,030

 

3. Other Certifications for Medical Device Applications

Additional certifications for medical device applications are listed below:

Other Certifications for Medical Devices	Applicable Fees (PHP, Inclusive of Legal research fee, LRF)
CPR Reapplication – Class A Devices	9,544.50
CPR Reapplication – Class B Devices	12,726.00
CPR Reapplication – Class C Devices	13,079.50
CPR Reapplication – Class D Devices	13,786.50
Medical Device Listing (one-time use)	3,434.00
Compassionate Special Permit (one-time use)	510.00

 

4. Payment Channels and Penalties

To streamline payment processes, the FDA has also introduced multiple payment channels, including online platforms such as LBP Link.BizPortal and over-the-counter options at Landbank of the Philippines. Applications submitted after license expiry will face penalties, including:

• A surcharge equal to twice the renewal fee.
• An additional 10% charge per month for delays within the allowable 120-day extension period.

 

Implications for Foreign Medical Device Stakeholders

Compliance Requirements

The updated fee schedule highlights the FDA’s focus on safety and efficacy, requiring foreign manufacturers and distributors to enhance compliance. Accurate financial planning for regulatory fees is crucial to ensure uninterrupted product importation and market access.

Benefits to Stakeholders

Despite the higher fees, these changes promise benefits:

• Improved regulatory support and streamlined importation processes.
• Enhanced safety and quality assurance through modernized FDA infrastructure.
• Greater transparency in navigating the Philippine regulatory landscape.

 

Industry Challenges and Opportunities

Challenges

Foreign manufacturers and distributors may face increased operational costs due to the revised fees. Additionally, adapting to new processes and fee schedules might require enhanced collaboration with local partners and regulatory consultants.

Opportunities

Compliance with updated regulations positions foreign entities to build trust with local partners and consumers. This adherence ensures smooth importation and long-term access to a growing market in the Philippines.

 

Conclusion and Call to Action

Administrative Order No. 2024-0016 marks a pivotal step in modernizing the FDA’s regulatory framework, reflecting the growing demands of the health product industry. For foreign manufacturers and distributors, these updates represent both a challenge and an opportunity to streamline compliance and strengthen their presence in the Philippine market.

Qualtech Consulting Corporation has been a trusted partner for foreign medical device manufacturers and regional distributors for 25 years. Whether you’re navigating initial product registration or renewing licenses, we empower your devices to reach the Philippine market and enhance lives.

Connect with us today to unlock your medical device potential.

 

 

References

1. Administrative Order No. 2024-0016. Implementing Guidelines on the New Schedule of Fees and Charges of the Food and Drug Administration. Retrieved from PH FDA website.
2. Administrative Order No. 2001-0050. FDA Administrative Orders related Fees and Charges. Retrieved from PH FDA website.