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LAUNCHING OF THE NEW MeDC@St 2.0+
About MeDC@St
MeDC@St is the acronym of Medical Device Centralised Online Application System, an online system to manage various applications made to MDA. Since its launch in July 2013, MeDC@St has been upgraded to MeDC@St 2.0 in January 2019. Commencing 1 February 2022, MDA is proud to introduce another enhancement to the online application system, ie the MeDC@St2.0+, which will incorporate additional features for the benefit of the users. MeDC@St2.0+ is evidence of the commitments for continuous quality improvement of our services Additional features MeDC@St2.0+ incorporates the following new features:
- Change Notification module
- Combination of Category 2 and Category 3 changes in an application using single submission ID number
- Combination of Category 2 and Category 3 changes in an application for multiple submission ID numbers (for a same risk-based classification)
- Change notification letter can be downloaded and printed directly from MeDC@St2.0+ account
- Device Study sub-module (under Clinical Research module)
- Various selections of notification types will be made available
- Notifications relating to a device study (including adverse event reporting and scheduled progress report) can be made online until completion of the study
- Notification letter can be downloaded and printed directly from MeDC@St2.0+ account
- Clinical Research Use sub-module (under Clinical Research module)
- New online form has been developed;
- A structured subsequent notification process that allows notification to be made repeatedly;
- Notification letter can be downloaded and printed directly from MeDC@St2.0+ account
- Demonstration for Marketing Notification module provides new feature on the selection of medical device category
- Payment module incorporates payment via credit card in addition to the existing payment methods via bank draft and FPX. Under MeDC@St2.0+, MDA will enforce a 30-day term for all payments; failing which, the application will be automatically dropped from MeDC@St2.0+, and the establishments shall make a fresh application.
Training
MDA will provide a series of training session on the new modules on the date that will be announced later.
User Manuals
MeDC@St2.0+ users may refer to the following user manuals:
- User manual Clinical Research Use: https://ddms.mda.gov.my/share/s/gOMNoF90T0m8b2nHVn644w
- User manual Demonstration and Education: https://ddms.mda.gov.my/share/s/OiO3Is2PRha3n2ULJT4Azg
- User manual Change Notification Class A: https://ddms.mda.gov.my/share/s/IDD-_gitQbG8_wS4hrwo9g
- User manual Change Notification Class B, C, and D: https://ddms.mda.gov.my/share/s/cthSmsjnQV2AjT11LGSFlA
- Demonstration and Education : https://ddms.mda.gov.my/share/s/OiO3Is2PRha3n2ULJT4Azg
- Device Study: https://ddms.mda.gov.my/share/s/uCfOb6YNRnujtIUavwp_9Q
- Payment : https://ddms.mda.gov.
my/share/s/ PCwuNMbSRGyD8NVrgzULYQ
- The user manuals will be updated from time to time
Inquiry
Any inquiry about application do not hesitate to contact each Modul/Sub-Modul representatives at:
|
No. |
Modul/ Sub-Modul |
|
Contact Number |
|
1 |
MDR – Change Notification |
03-82300376 |
|
|
2. |
Notification – Clinical Research Use |
03-82300339 |
|
|
3. |
Notification – Device Study |
03-82300339/ 03-82300343 |
|
|
4. |
Notification – Demonstration & Education |
03-82300209 |
|
|
5. |
Payment |
- |
03-82300334/ 03-82300326 |
Technical Issues
Should you encounter any technical issues related to MeDC@St2.0+, please report to https://medcast.mda.gov.my/medcasthelpdesk/index.php; or https://femes.mda.gov.my/; or to our IT personnels at 03 8230 0222 (Syafiq); or 03 8230 0221 (Zainul).
Updated: 1 March 2022
