Introduction       

The Export Certificate (EC) is a certificate issued by MDA as a service to Malaysia exporters to export the Export Only Medical Device from Malaysia to a foreign country.

An Export Only Medical Device Exemption Letter issued by MDA shall be first obtained prior to the Export Certificate application.

Note: For more information on Export Only Medical Device Exemption Letter, please Click Here

 

Application procedure

The applicant who needs Export Certificate in order to comply with importing country requirements is required to submit an application via Google Form together with all supporting documents listed below:

 

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

Table 1: Supporting documents for export certificate

 

 

The EC will be issued by MDA upon satisfactory review of all the supporting documents provided as required and subject to payment of the fees.

 

images_23456.png

 

The turn-around time is 14 working days with complete documentation.

 

Fees

Below are the applicable fees

i) Application fee: RM 250.00

ii) Export certificate fee. The fee for EC is as follows:

 

No

Validity

Fee (RM)

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

 

 

The payment shall be made online via BayarNow system. Click on BayarNow for more information.

For any inquiries, please email to exportonly.ec@mda.gov.my

The contact number of the relevant officers:

1.     

Mdm. Norhafizah

03-8230 0208

2.     

Mr. Fezri 

03-8230 0395

3.     

Mr. Shahrezza 

03-8230 0392
   

 

 

Updated: 25 October 2023