In July 2013, The Medical Device Centralised Online Application System, abbreviated as MeDC@St, was introducedas a system to manage applications made to the MDA. It was upgraded to MeDC@St 2.0 in January 2019 and commencing on 1 February 2019, MeDC@St 2.0+ was introduced with additional features for the benefit of users. This article will cover these new features implemented.
The new features:
1. 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
2. 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
3. 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
4. Demonstration for Marketing Notification module provides new feature on the selection of medical device category
5. 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.
User manuals
Listed are user manuals for ease of use of MeDC@St2.0+.
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
Sources: Launching of new MeDC@St 2.0+
Contact us at info@arqon.com for more info