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
- Pre-market Consultation Fees
All fees below are in Singapore Dollars (SGD).
Product Registration and Applicable Evaluation Fees for Medical Devices
Table 1.1: Product Registration Fees
|Risk Class||Application Fees||Evaluation Fees|
|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).
Table 2: Annual retention fee per device listing
Dealer's Licence Fees
The following fees (Table 3) are payable for:-
- a new application for a dealer's licence, or
- annual renewal of a dealer's licence
Table 3: Dealer's licence fee per application
Change Notification and Licence Amendment Fees
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
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 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)||$50|
|- For each additional device||$50|
|- For each additional country||$50|
Change of Registrant Fees
|Application fee for change of registrant||$800|
Authorisation Route Fees
The following fees (Table 7) are payable for application for a licence to import 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 and supply on request by qualified practitioner for use on his patient||$150|
|GN-27: Import and supply on request by Private Hospital, Medical Clinic or Clinical Laboratory licensed under the PHMC Act for use on their patients||$350|
|GN-28: Import and supply for export or re-export||$250|
|GN-29: Import and supply for Non-Clinical Purpose||
Pre-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
|Medical Device Development Consultation||$500 (per device per consultation, up to 2 hours)|
|Medical Device Pre-submission Consultation||$200 (per device application per consultation, up to 1 hour)|