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:

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