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This application is a service of the Singapore Government.

Health Sciences Authority

Fees and Charges

Product Registration and Applicable Evaluation Fees for Medical Devices

Table 1: Product Registration Fees

Risk Class Application Fees Evaluation Fees
    IBR Expedited Abridged Full
Class A (Non-Exempt) $25 - - - -
Class B $500 $900 $900 $1,800 $3,500
Class C $500 - $3,000 $3,500 $5,700
Class D $500 - $5,400 $5,700 $11,400
Class D, devices incorporating medicinal/therapeutic products $500 - - $10,000 $75,000

Please refer to GN-15 Guidance on Medical Device Product Registrationon eligibility criteria for the different evaluation routes for medical devices.

Annual Retention Fees for Medical Devices listed on SMDR

  1. An annual fee is payable to maintain a medical device on the Singapore Medical Device Register (SMDR).
  2. From 10 August 2011, annual listing fees are payable for Class C and D medical devices.
    From 01 January 2013, annual listing fees are payable for Class A and B medical devices.

Table 2: Annual retention fee per device listing

Risk classification Fees
Class A S$25
Class B S$35
Class C S$60
Class D S$120

Dealer's Licence Fees

  1. From 10 August 2010, companies without valid dealer's licence(s) shall not be allowed to manufacture/ import/ supply medical devices.
  2. From 10 August 2010, the following fees (Table 3) shall be payable for:-
    • a new application for a dealer's licence, or
    • annual renewal of a dealer's licence
  3. Annual renewal licence fees are payable from 01 September 2011 for all dealer's licences.

Table 3: Dealer's licence fee per application

Licence Type Fees 
Manufacturer S$1,000
Importer S$1,000
Wholesaler S$1,000

Change Notification and Licence Amendment Fees

Dealer's Licence

From 10 August 2010, the following fees (Table 4) are payable upon submission of a licence amendment application for a dealer's licence.

Table 4: Fee per licence amendment application for a dealer's licence

Licence Type Fees
Manufacturer S$150
Importer S$150
Wholesaler S$150

Change Notification

2. From 1 April 2014, the following fees (Table 5) are applicable for change notification applications. Applicable evaluation fees have been factored into change notification applications involving technical changes. Please refer to GN-21 Guidance on Change Notification for more information.

Table 5: Change Notification Fees

Risk classification Notification Changes(No fees are applicable) Administrative Changes Review Changes Technical Changes
Class A(Sterile)  - $25 $25 Not applicable
Class B - $500 $500 Not applicable
Class C - $500 Not applicable $1,700
Class D(including devices incorporating medicinal/therapeutic products in an ancillary role) - $500 Not applicable $2,800

Fees and Charges for Certificates

Free Sale Certificate or Export Certificates

Table 6: Fees applicable for free sales certificates:

Licence Type Fees 
Application fee S$50
Processing fee (for one device and one country) S$50
- For each additional device S$50
- For each additional country S$50
Duplicate copy of certificate S$50

With effect from 1 April 2013, HSA will no longer be issuing Certificate of Origin (COO) for medical devices but will issue Free Sale Certificates (FSCs) to local product owners of finished medical devices that have been registered with HSA.

The issuance of COO comes under the Regulation of Imports and Exports Act and is issued by Singapore Customs or the 6 Authorised Organisations (AOs) listed on the Singapore Customs website. For further information on how to obtain a COO from Singapore Customs, please refer to their website:

Change of Registrant Fees

Application fee for change of registrant S$800

Authorisation Route Fees

Authorisation Routes

  1. From 10 August 2010, the following fees (Table 7) are payable for application for a licence to import or wholesale an unregistered medical device for supply in accordance to the specified authorisation routes below.

Table 7: Authorisation Route Fees

Authorisation Route Type Fees
GN-26: Import/Wholesale and Supply on Named-Patient Basis S$150
GN-27: Import/Wholesale and Supply to Private Hospital, Medical Clinic or Clinical Laboratory licensed under the PHMC Act (Cap. 248)   S$350
GN-28: Import/Wholesale for Export or Re-export S$250
GN-29: Import/Wholesale for Supply for Non-Clinical Purpose S$250

HSA Inspection Scheme

HSA Inspection Scheme (til 2013)
Fee for amendment to GDPMDS scope (with on-site inspection) S$1000
Fee for amendment to GDPMDS scope (without on-site inspection) S$150
Annual fee for HSA Inspection Scheme S$1000