1. Online preregistration is compulsory for all applicants (https://mkak-apps.moh.gov.my/ites).

2. Application must be submitted through email, it.mkak@moh.gov.my.

3. Status of application will be notified within 7 working days. Payment slip and official invoice will be issued.

4. Submission of IVD Test/ Assay and payment for evaluation must be completed within 14 days after the official invoice is issued. FAILURE to do so, will lead to CANCELLATION of the request.

5. All payments made are NON-REFUNDABLE.

6. IVD Test/Assay Evaluation Report shall be issued within 3 months upon completion of payment.

7. The evaluation report for Medical Device Authority (MDA) purpose will be submitted directly to MDA. Any other evaluation report will be issued directly to the respective applicants.

8. Below are steps to activate ITES account & services application:
   • Click button "Applicant Company Login".
   • "Register as applicant", fill up the form and send it to it.mkak@moh.gov.my.
   • An email will be sent to confirm your account has been registered.
   • Fill up the IVD Test Assay/ Evaluation Application form and click Submit.
   • Upload all documents required.
   • Payment Charges slip will be displayed and applicant MUST click Accept Charges if the charges are agreeable. 

9. Applicants can view their application status at the system dashboard.

Please contact us/ drop us an email :

Tel No : 03-6126 1200 / ext 1331
Email   : i-tes.nphl@moh.gov.my