CLINICAL RESEARCH STUDY

A. Guidance Document : Notification of Exemption from Registration of Medical Devices for The Purpose of Clinical Research or Performance Evaluation- "Document 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 

       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

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,

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

Importance Notice :

None

Updated : 4th January 2022

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