Definition : “clinical research” means any systematic investigation or study that determines the safety and effectiveness of medications, devices, diagnostic products, medical procedures and treatment regimens intended in or on one or more human subjects, in an adequate human clinical environment.

A. Link to online Notification Form : Medcast 

B. Instant Guide to Create Medcast Account :  Annex B Flow Chart

C. Instant Guide for Device Study (DS) Notification:

       1. Device Study Flow Chart

       2. E-Submission Guide for New Notification

       3. E-Submission Guide for Subsequent Notification

       4. E-Submission Guide for Adverse Event Reporting

       5. Technical Committee Meeting Calendar (TCMDCE)

       6. Clinical Investigational Plan (CIP) - ISO14155 

       7. Clinical Performance Study Protocol (CPSP)

       8. Investigational Brochure (IB) - ISO 14155

 9. Refer Standard 14155

 

D. Instant Guide for Clinical Research Use (CRU) Notification:

       1. Explanatory on Notification of Exemption for Clinical Research Use  : CRU

       2. Annex A : CRU Flow Chart

       3. Annex C : E-Submission Guide for New Notification

       4. Annex D : E-Submission Guide for Subsequent Notification

       5. Annex E : Form Notification for Export /Disposal of Devices After Research Completion /Termination

E. Any inquiries, please email to: ci @ mda.gov.my

F. Contact number of the relevant officers:

     Device Study :

     1. Puan Nur Syafura +603-8230 0352

     2. Pengarah, Puan Aidahwaty Bt Ariffin +603-8230 0341 (Whatsapp only : 016-3337031)

    Clinical Research Use :

     1. Puan Nur Athirah Bt Hashim +603-8230 0385

     2. Puan Rosmani +603-8230 0371

     3. Puan Nur Syafura +603-8230 0352

 

Importance Notice :

None

Updated : 26 February 2024