Get Your Products Ready for Market!
For Exhibitors - Here's a special offer from Malaysia's leading regulatory consultants. 35% Reduction SEACare Exhibitors Registration for Malaysia Post Market Surveillance and Vigilance Reporting to Medical Device Authority (only applicable if the device has issue of complaint and recall, not common) Fees to Authority and Conformity Assessment Body
Valid for 5 years Contact: T T MEDICAL MANAGEMENT SDN. BHD. Mobile : +6012 278 9119 E-mail : melisa.leeau@ttmedical.com.my
Go ahead and contact them directly.
No
Description
Total Cost
35% Discount
Remarks
1
Annual Fees as license holder for foreign manufacturer
€2400
€1560
Every 5 years Registration Fees
2
Medical Device Adminstration Fee for Class A
(will waive the first Adminstration fees for first Class A Device)€900/Device
€585
3
Medical Device Administration Fee for Class B, C
€2000/Device
€1300
4
Medical Device Adminstration Fee for Class D
€3000/Device
€1950
5
Medical Device with Medicinal Adminstration Fee
€4000/Device
€2600
6
**Notifications / Device Classification
€1000/Device
Not applicable for reduction
Change of Ownership
€100/Device
Not applicable for reduction
Change of Notification for Registered Medical Device for Category 3
€200/Device
Only applicable if there are changes during the years registration on the device technical files
Change of Notification for Registered Medical Device for Category 2
€500/Device
Variation Fee
€250
€350/Device
6
Registration Fees for Class A (waived)
RM100
7
Registration Fees for Class B
RM1250
8
Registration Fees for Class C
RM2500
9
Registration Fees for Class D
RM3750
10
Registration Fees for Medical Device that contains a
Medicinal ProductRM5750
11
Conformity Assessment Fees to CAB
Note: The fees structure assumes that the devices have obtained
with one of the Approved Countries Registration such as
CE, US FDA, TGA, Japan and Canada. Only applicable for Class B,C,D.From €200-300
per Device
Melisa Leeau
Managing Director