June 12, 2018
Administrative Order 2018-117, otherwise known as the “Effectivity of the New Schedule of Fees” was released in the 2nd of April, 2018 to inform all the FDA Stakeholders and the General Public that a new schedule of fees shall be implemented on the 30th of June 2018.
The new schedule of fees being referred to in this Order, was drafted in 03 June 2016. Summary of fees related to Medical Devices Registration, Licensing and Amendments found in Annex D of the said draft were hereby outlined as follows:
Fees related to License to Operate
|
LICENSE TO OPERATE (Medical Device) |
Fees (in Php) |
|
|
Initial (2 years) |
Renewal (3 years) |
|
|
Manufacturer/Repacker |
50,000.00 |
75,000.00 |
|
Distributor (Importers, Exporters and Wholesalers) |
15,000.00 |
22,500.00 |
|
VARIATIONS |
||
|
Major Variations-Manufacturer |
5,000.00 |
|
|
Minor Variations |
1,000.00 |
|
Fees related to Medical Device Registration
|
PRODUCT REGISTRATION (Medical Device) |
Fees (in Php) |
|
|
Initial (5 years) |
Renewal (5 years) |
|
|
Class A |
15,000.00 |
15,000.00 |
|
Class B |
30,000.00 |
30,000.00 |
|
Class C |
40,000.00 |
40,000.00 |
|
Class D |
60,000.00 |
60,000.00 |
|
VARIATIONS |
||
|
Minor Variations 1 |
3,000.00 |
|
|
Minor Variations 2 |
6,000.00 |
|
|
Minor Variations |
1,000.00 |
|
*The Minor Variations are categorized into 3, namely /minor variations 1’, ‘minor variations 2’ and ‘minor variations’. PFDA has confirmed that the definitions of these categories are yet to be finalized.
Fees related to Medical Device Laboratory Services
|
Period of charging |
Fees (in Php) |
|
|
Performance testing per x-ray machine |
Per machine |
20,000.00 per machine plus transportation cost of the health physics team |
|
Calibration of radiotherapy dosimeter (electrometer & ion chamber) |
Per dosimeter |
8,000.00 per dosimeter |
|
Rental of non-invasive kV meter and related accessories as 1 set |
Per day of use, or fraction thereof |
7,000.00/day |
|
Rental of non-electronic x-ray QA test tools |
Per day of use, or fraction thereof |
7,000.00/day |
|
Rental of selective frequency meter for radio frequencies |
Per day of use, or fraction thereof |
15,000.00/day |
|
Rental of densitometers |
Per day of use, or fraction thereof |
6,000.00/day |
|
Rental of densitometers |
Per day of use, or fraction thereof |
6,000.00/day |
The final schedule of fees is expected to come out in the 30th of June. For the meantime, the old schedule of fees shall still take effect.
Moreover, the Food and Drug Action Center (FDAC) has announced that they will no longer accept cash payments starting on the same date. Instead, payments shall be done either via Bancnet Online Payment (www.bancnet.com) or Landbank of the Philippines (LBP) Oncoll Payment.
As for the specific details of Collection and Policy and Procedure, the other provisions under FDA Circular 2017-010 shall still be followed.
Manufacturers and Applicants are advised to keep themselves posted regarding the final details on fees related to License to Operate, Medical Device Registration and Post Approval Applications (or Product Amendments). Furthermore, it is recommended that manufacturers process registration and amendment applications as early as now, before any rise in charges take place.
References:
1. Republic of the Philippines – Food and Drug Administration (AO 2018-117). (2018). Metro Manila: Accessed here.
2. Republic of the Philippines – Food and Drug Administration (Draft AO:New Schedule of Fees and Charges of the Food and Drug Administration for Licensing, Registration and Other Certifications). (2016). Metro Manila: Accessed here.