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CLINICAL RESEARCH STUDY

 

 CRU IMAGE

 

 

A. Guidance DocumentNotification of Exemption from Registration of Medical Devices for The Purpose of Clinical Research or Performance EvaluationDocument under revision

B. Link to online Notification Form : Medcast 

C. Instant Guide to Create Medcast Account :  Flow Chart

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

       1. Device Study Flow Chart

       2. E-Submission Guide for New Notification - soon

       3. E-Submission Guide for Subsequent Notification - soon

       4. E-Submission Guide for Adverse Event Reporting - soon

       5. Technical Committee Meeting Calendar (TCMDCE)

       6. Clinical Investigational Plan (CIP) – ISO14155

       7. Investigational Brochure (IB) - ISO14155

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

       1. CRU Flow Chart

       2. E-Submission Guide for New Notification

       3. E-Submission Guide for Subsequent Notification

       4. Form Notification for Export /Disposal of Devices After Research Completion /Termination

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

G. Contact number of the relevant officers:

       1. Device Study : Puan Aidahwaty Bt Ariffin +603-8230 0341,

                                    Puan Nur Maizura Bt Zarmani +603-8230 0339,

                                    En. Muhammad Hisyam Bin Ibrahim +603-8230 0246

       2. Clinical Research Use (CRU) : Puan Nur Maizura Bt Zarmani +603-8230 0339

 

Importance Notice :

None

Updated : 25th May 2022

Cetak

  Pihak Berkuasa Peranti Perubatan Malaysia,
Kementerian Kesihatan Malaysia,
Aras 6, Prima 9, Prima Avenue II,
Block 3547, Persiaran APEC,
63000 Cyberjaya, Selangor, MALAYSIA

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

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