The Health Sciences Authority (HSA) has published an update on the Regulatory Fees for Health Products. This is to ensure that the evaluated products meet the required standards of quality safety and efficacy. It is also necessary to recover part of the costs for the services rendered to businesses. This will be effective on July 1, 2022.
The table below shows the revised fee for specific transactions:
Product Registration and Evaluation Fees
|
Transaction Type |
Class B |
Class C |
Class D |
Class D with a Registrable Drug |
|
Application |
$ 530 |
$ 530 |
$ 530 |
$ 530 |
|
Immediate |
$ 950 |
$ 3,180 |
Not Applicable |
Not Applicable |
|
Expedited |
Not Applicable |
$ 3,180 |
$ 5,730 |
Not Applicable |
|
Abridged |
$ 1,910 |
$ 3,710 |
$ 6,050 |
$ 10,400 |
|
Full |
$ 3,710 |
$ 6,050 |
$ 11,800 |
$ 75,400 |
Full Route Priority Review Scheme Fees
|
Transaction Type |
Class B |
Class C |
Class D |
|
Application |
$ 530 |
$ 530 |
$ 530 |
|
Route 1 |
$ 4,220 |
$ 6,800 |
$ 13,400 |
|
Route 2 |
$ 5,460 |
$ 8,800 |
$ 17,300 |
Annual Retention Fees for Medical Devices Listed on the Singapore Medical Device Register (SMDR)
|
Class B |
$ 37 |
|
Class C |
$ 64 |
|
Class D |
$ 128 |
|
Class D with a Registrable Drug |
$ 128 |
Manufacturers and Dealers’ License Fees
|
Transaction Type |
Manufacturer |
Importer |
Wholesaler |
|
New Application |
$ 1,060 |
$ 1,060 |
$ 1,060 |
|
Annual Renewal |
$ 1,060 |
$ 1,060 |
$ 1,060 |
|
Amendment |
$ 160 |
$ 160 |
$ 160 |
Change Notification
|
Transaction Type |
Class B |
Class C |
Class D |
|
Administrative |
$ 530 |
$ 530 |
$ 530 |
|
Review |
$ 530 |
Not Applicable |
Not Applicable |
|
Technical |
Not Applicable |
$ 1,800 |
$ 2,970 |
Free Sale Certificates (FSC) Fees
|
Application |
$ 54 |
|
Processing for One Device and One Country |
$ 54 |
|
Processing for Each Additional Device |
$ 54 |
|
Processing for Each Additional Country |
$ 54 |
Change of Registrant Application Fee – $ 840
Special Access Routes (SAR) Fees
|
Unregistered Devices Requested by Qualified Practitioners |
$ 160 |
|
Unregistered Devices Requested by a Licensed PHMC |
$ 370 |
|
Import for Re-Export of Unregistered Devices |
$ 266 |
|
Unregistered Devices for Non – Clinical Purpose |
$ 266 |
References:
Regulatory Fee Revision for Health Products
List of Revised Fees for Health Products