print small large

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 1.1: 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

Table 1.2: Product Registration Fees (Priority Review Scheme)

Risk Class Application Fees Evaluation Fees (Priority Review Scheme)
    Full (Route 1) Full (Route 2)
Class B $500 $4,100 $5,300
Class C $500 $6,600 $8,600
Class D $500 $13,200 $17,100

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


Back to top

 

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

Back to top

 

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

Back to top

 

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

Back to top

 

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

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:
http://www.customs.gov.sg/businesses/exporting-goods/certificates-of-origin


Back to top

 

Change of Registrant Fees

Application fee for change of registrant S$800

Back to top

 

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


Back to top

 

0Pre-market Consultation Fees

The following fees (Table 8) are payable for Pre-market Consultations. For further information on the scheme, click here.

Table 8: Fee per consultation session

Consultation Category Fees
Medical Device Development Consultation S$500 (per device per consultation, up to 2 hours)
Medical Device Pre-submission Consultation S$200 (per device application per consultation, up to 1 hour)

Back to top