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Clinical Research / Performance Evaluation

*Note :-

Additional Information On Submission Of Clinical Research Notification

 Graph FlowChart CI

 

Instant guide to Clinical Research Use (CRU) Subsequent/Change

 

Subsequent Application

Notification of Change

Clinical Research Use (CRU)

Add device only

Add site and device

Change of device

Change of trial site

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.

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.


INFO:

  1. 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.
  2. 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.

 

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  Medical Device Authority (MDA),
Ministry of Health Malaysia,
Level 6, Prima 9, Prima Avenue II,
Block 3547, Persiaran APEC,
63000 Cyberjaya, Selangor, MALAYSIA

  +603 - 8230 0300
  +603 - 8230 0200 
  mdb@mda.gov.my