Fees and turnaround time for medical devices
Here is the list of fees and turnaround times to help you with your medical device transactions.
Please be informed that the turnaround times may be extended by 20% in 2022.
Fees for product registration
| Fees |
Class B |
Class C |
Class D |
Class D with a registrable drug |
| Application fee |
$530 |
$530 |
$530 |
$530 |
| Immediate route fee |
$950 |
$3,180 |
N.A. |
N.A. |
| Expedited route fee |
N.A. |
$3,180 |
$5,730 |
N.A. |
| Abridged route fee |
$1,910 |
$3,710 |
$6,050 |
$10,400 |
| Full route fee |
$3,710 |
$6,050 |
$11,800 |
$75,400
|
| Full route (Priority Review Scheme Route 1) |
$4,220 |
$6,800 |
$13,400 |
N.A. |
| Full route (Priority Review Scheme Route 2) |
$5,460 |
$8,800 |
$17,300 |
N.A. |
| Annual retention fee for SMDR listing |
$37 |
$64 |
$128 |
$128 |
Fees for change of registrant
The fee for change of registrant is $840.
Turnaround time (in working days)
| Registration route |
Class B |
Class C |
Class D |
Class D with a registrable drug |
| Immediate route |
Immediate upon submission |
Immediate upon submission |
N.A. |
N.A. |
| Expedited route |
N.A. |
120 |
180 |
N.A. |
| Abridged route |
100 |
160 |
220 |
220 |
| Full route |
160 |
220 |
310 |
310 |
| Full route (Priority Review Scheme Route 1) |
120 |
165 |
235 |
N.A. |
| Full route (Priority Review Scheme Route 2) |
120 |
165 |
235 |
N.A. |
The turnaround time for change of registrant is 40 working days.
Note: Turnaround time excludes the time taken for you to respond to our requests for clarification or additional information ("applicant's stop-clock").
Payment modes
Fees and turnaround time
| Application type |
Fees for all medical devices |
Turnaround time (in working days) |
| New application |
$1,060 |
10 |
| Annual renewal |
$1,060 |
10 |
| Dealer's licence amendment |
$160 |
10 |
Note:
- Licences are valid for 12 months from the date of licence approval. Renewal of licences must be submitted and processed before the expiry.
- Turnaround time excludes the time taken for you to respond to our requests for clarification or additional information ("applicant's stop-clock").
Payment modes
Fees
There are no fees applicable for notification changes. Fees for other changes are stated in the table.
| Change |
Class B |
Class C |
Class D |
| Administrative |
$530 |
$530 |
$530 |
| Review |
$530 |
N.A. |
N.A. |
| Technical |
N.A. |
$1,800 |
$2,970
|
Turnaround time (in working days)
| Change |
Class B |
Class C |
Class D |
| Administrative |
30
|
30
|
30 |
| Review |
45 |
N.A.
|
N.A.
|
| Technical |
N.A. |
75
|
90
|
Note:
- Turnaround time excludes the time taken for you to respond to our requests for clarification or additional information ("applicant's stop-clock").
- Contact us for turnaround time regarding changes to Class D medical devices with a registrable drug in a secondary role.
Payment modes
Fees
| Fee type |
Fees |
| Application fee |
$54 |
| Processing fee for one device and one country |
$54 |
| Processing fee for each additional device |
$54 |
| Processing fee for each additional country |
$54
|
Fees and turnaround time
| Special Access Routes |
Fees |
Turnaround time (in working days) |
| Import for re-export of unregistered devices |
$266 |
14 |
| Unregistered devices for non-clinical purposes |
$266 |
14 |
| Unregistered devices requested by qualified practitioners |
$160 |
14 |
| Unregistered devices requested by a licensed PHMC |
$370 |
14 |
Note:
- The validity period is 12 months from the date of approval.
- Turnaround time excludes the time taken for you to respond to our requests for clarification or additional information ("applicant's stop-clock").
Payment modes
Fees
| Consultation type |
Fees |
| Medical device development consultation |
$500 for each device per consultation, for up to two hours |
| Medical device pre-submission consultation |
$200 for each device application per consultation, for up to one hour
|