More Information
    
    
    



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

E-mail  : melisa.leeau@ttmedical.com.my

 

 

 

Back to Top