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

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