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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 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
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