No

Supporting Documents

1

Export certificate application form

2

Export Only Medical Device Exemption Letter issued by MDA

3

Medical device list

4

Medical device label (shall be provided based on importing country information as stated in the application form)

5

Attestation

1

2 years

100

2

5 years

300

-       Calculation is based per number of countries requested.

-       Certificate is inclusive of 1 attachment. Additional pages will be charged RM5.00 per page. Each attachment will list up to 25 medical devices.

-       Certificate will be issued based on per country.

Export Certificate Calculation Fees

      i.         

1 Country

100 medical devices

1 copy of certificate

Validity 2 years

25 medical devices per attachment thus require 4 attachments. (complimentary 1 attachment).

RM 250 (application fee) + RM 100 (2 years validity) + RM15 (Attachment) = RM 365

    ii.         

1 Country

100 medical devices

2 copies of certificate

Validity 2 years

25 medical devices per attachment thus require 4 attachments. (complimentary 1 attachment).

RM 250 (application fee) + RM 100 (2 years validity) + RM15 (Attachment) = RM 365 for 1 EC

For 2 copies: RM 250 (application fee) + (RM 120 x 2) = RM 485

   iii.         

2 Countries

1 medical device

1 copies of certificate

Validity 5 years

RM 250 (application fee) + [RM 300 (Validity 5 years) x 1 (Attachment) x 1 (copy) x 2 (countries)] = RM 850

1.     

Mdm. Norhafizah

03-8230 0208

2.     

Mr. Fezri 

03-8230 0395

3.     

Mr. Shahrezza 

03-8230 0392