Fees and turnaround time for medical devices

Here is the list of fees and turnaround times to help you with your medical device transactions.

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

Change notification

There are no fees applicable for notification changes.

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 Contact us
Technical Changes $3,120

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  
  • for each additional device
   $ 57
  • for each additional country
   $ 57

Pre-market consultations

Pre-market consultations

Pre-market consultations Fees
MD development consultation  

$530
for each device per consultation,
for up to two hours
MD pre-submission consultation  

$210
for each device application per consultation,
for up to one hour

Special Access Routes

Special Access Routes

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