Get Your Products Ready for Market!

For Exhibitors - Here's a special offer from Malaysia's leading regulatory consultants.

Go ahead and contact them directly.

35% Reduction SEACare Exhibitors Registration for Malaysia
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
	Post Market Surveillance and Vigilance Reporting to Medical Device Authority (only applicable if the device has issue of complaint and recall, not common)	€350/Device

Fees to Authority and Conformity Assessment Body

6	Registration Fees for Class A (waived)	RM100	Valid for 5 years
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 Product	RM5750
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

Contact:
Melisa Leeau
Managing Director

T T MEDICAL MANAGEMENT SDN. BHD.

Mobile : +6012 278 9119