Fees and turnaround time for medical devices
Here is the list of fees and turnaround times to help you with your medical device transactions.
Fees are payable via GIRO (apply eGIRO) or eNETS
Turnaround time (TAT) excludes the time taken for you to respond to our requests for clarification or additional information ("applicant's stop-clock").
Product registration
Medical Devices Registration
Medical Devices Registration Applications | Fees | TAT (in working days) |
Application fees for any Class B, C or D device registration | $560 | NA |
Class B evaluation routes | ||
Immediate route | $1,000 | Immediate upon submission |
Abridged route | $2,010 | 100 |
Full route | $3,900 | 160 |
Full route (Priority Review Scheme Route 1) | $4,420 | 104 |
Full route (Priority Review Scheme Route 2) | $5,660 | 104 |
Class C evaluation routes | ||
Immediate route | $3,340 | Immediate upon submission |
Expedited route | $3,340 | 120 |
Abridged route | $3,900 | 160 |
Full route | $6,250 | 220 |
Full route (Priority Review Scheme Route 1) | $7,000 | 143 |
Full route (Priority Review Scheme Route 2) | $9,000 | 143 |
Class D evaluation routes | ||
Expedited route | $5,930 | 180 |
Abridged route | $6,250 | 220 |
Full route | $12,000 | 310 |
Full route (Priority Review Scheme Route 1) | $13,600 | 202 |
Full route (Priority Review Scheme Route 2) | $17,500 | 202 |
Class D with registrable drug evaluation routes | ||
Abridged route | $10,600 | 220 |
Full route | $75,600 | 310 |
Annual retention in the Singapore Medical Device Register (SMDR)
Annual retention of medical devices | Fees | TAT |
Class B | $39 | Upon successful retention fees payment before retention deadline |
Class C | $67 | |
Class D | $134 | |
Class D with registrable drug | $134 |
Change of registrant
Change of registrant | Fees | TAT |
Application for the change of registrant | $880 | 40 working days |
Change notification
There are no fees applicable for notification changes.
Change notification
Change notification applications | Fees | TAT (in working days) |
Class B | ||
Administrative Changes | $ 560 | 30 |
Review Changes | $ 560 | 45 |
Class C | ||
Administrative Changes | $ 560 | 30 |
Technical Changes | $1,890 | 75 |
Class D | ||
Administrative Changes | $ 560 | 30 |
Technical Changes | $3,120 | 90 |
Class D with registrable drug | ||
Administrative Changes | $ 560 |
Importer’s, Wholesaler’s and Manufacturer’s Licence
Importer’s, Wholesaler’s and Manufacturer’s Licence
Dealer’s licence applications | Fees | TAT |
NEW or ANNUAL RENEWAL* of dealer’s licence | ||
Importer’s Licence | $1,110 | 10 working days |
Wholesaler’s Licence | $1,110 | |
Manufacturer’s Licence | $1,110 | |
AMENDMENT application for dealer’s licence | ||
Importer’s Licence | $ 168 | 10 working days |
Wholesaler’s Licence | $ 168 | |
Manufacturer’s Licence | $ 168 |
*Licence will be renewed upon successful renewal fees payment before licence expiry date.
Free Sale Certificates and Export Certificates
Free Sale Certificates (FSC) and Export Certificates
FSC and Export Certificates | Fees | TAT |
Application fees | $ 57 | 14 working days |
Processing fees for one device and one country | $ 57 | |
Processing fees | ||
| $ 57 | |
| $ 57 |
Pre-market consultations
Pre-market consultations and its fees
Pre-market consultations | Fees |
MD development consultation | $530 |
MD pre-submission consultation | $210 |
Special Access Routes
Special Access Route (SAR) and its fees
Special Access Route (SAR) applications | Fees | TAT |
Import for re-export of unregistered devices | $280 | 14 working days |
Unregistered devices for non-clinical purpose | $280 | |
Unregistered devices requested by qualified practitioners | $168 | |
Unregistered devices requested by a licensed healthcare facility | $390 |
