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:
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:
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) Puan Nur Maizura Bt Zarmani +603-8230 0339
2) Puan Nur Athirah Bt Hashim +603-8230 0385
3) Puan Aidahwaty Bt Ariffin +603-8230 0341
Importance Notice :
None
Updated : 5 APRIL 2023