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