Fees and Charges
- Product Registration and Applicable Evaluation Fees for Medical Devices
- Annual Retention Fees for Medical Devices listed on SMDR
- Dealer's Licence Fees
- Change Notification and Licence Amendment Fees
- Fees and Charges for Certificates
- Change of Registrant Fees
- Authorisation Route Fees
Product Registration and Applicable Evaluation Fees for Medical Devices
Table 1.1: Product Registration Fees
|Risk Class||Application Fees||Evaluation Fees|
|Class A (Non-Exempt)||$25||-||-||-||-|
|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)|
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
- An annual fee is payable to maintain a medical device on the Singapore Medical Device Register (SMDR).
- 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
Dealer's Licence Fees
- From 10 August 2010, companies without valid dealer's licence(s) shall not be allowed to manufacture/ import/ supply medical devices.
- 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
- Annual renewal licence fees are payable from 01 September 2011 for all dealer's licences.
Table 3: Dealer's licence fee per application
Change Notification and Licence Amendment Fees
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
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:
|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:
Change of Registrant Fees
|Application fee for change of registrant||S$800|
Authorisation Route Fees
- 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||