Clinical Research / Performance Evaluation
- Guidance Document : Notification of Exemption from Registration of Medical Devices for The Purpose of Clinical Research or Performance Evaluation- Document under revision
- Notification to Import and/or Supply Medical Devices for Clinical Investigational Use*
- Notification to Import Medical Devices for Clinical Research Use*
- Notification of Change on Clinical Trial for Medical Devices Use*
- Clinical Investigational Use Progress Report
- Serious Averse Event (SAE) Reporting
- Notification for Export /Disposal of Devices Upon Completion /Termination of Clinical Investigation /Drug Study
- Technical Committee of Medical Device Clinical Evaluation (TCMDCE) Meeting Calendar
- Medical Research and Ethics Committee (MREC)
- For any inquiries please email to ci @ mda.gov.my
- Officer Incharge :
- Puan Nur Maizura (for Notification of Clinical Research Use - CRU) : +603-82300339
- Puan Nashirah (for Notification of Clinical Investigational Use - IU) : +603-82300343
- Puan Aidahwaty - +603 - 8230 0341
*Note :-
Additional Information On Submission Of Clinical Research Notification
Instant guide to Clinical Research Use (CRU) Subsequent/Change
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Subsequent Application |
Notification of Change |
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Clinical Research Use (CRU) |
Add device only |
Add site and device |
Change of device |
Change of trial site |
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Medcast instruction: Amend Section E : 1. Delete previous packing list and device in table list. 2. Add New Device details. Only device involved in the exchange need to remain on the list. Other Requirement : None |
Medcast instruction: 1. Amend Section D : Delete previous site and Add new site details. 2. Amend Section E : Delete previous device in table list and add new device details. 3. Amend Section F (if relevant)
Other Requirement : EC Letter for new site. |
Medcast instruction: 1. RadioButton: Click Change of device 2. Amend Section E : Please use device table to list out devices involved in the exchange. Other Requirement : None |
Medcast instruction: 1. RadioButton: Click Change of Site 2. Amend Section D : Update site and upload new EC/IRB. Name of PI and name of EC not required to be updated. Other Requirement : EC Letter for new site. |
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Remarks : |
1. Please add, update or remove previous device accordingly because all devices listed in the system will be appear in the Acknowledgement Notification letter. 2. Please add, update or remove previous site accordingly because all sites listed in the system will be appear in the Acknowledgement Notification letter. |
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INFO:
- Applicants are allowed to submit *Subsequent Notification/*Notification of Change only once. If applicant required to make more than one, please submit new notification and administrative charge will be imposed.
- Starting 1 Nov 2019, all MANUAL subsequent or change notification application through email will not be processed. Applicant required to submit new notification and administrative charge will be imposed.
