The Malaysian Medical Device Authority (MDA) has launched an enhanced version of MeDC@St, its online application system for medical device registrations, at the end of January 2022. MeDC@St 2.0+ will incorporate additional features such as changes to certain modules including:
Change Notification module
- Change notification applications are now allowed to combine Category 2 and Category 3 changes when using a single submission identification number.
- Change notification applications are now also allowed to combine Category 2 and Category 3 changes when using multiple submission identification numbers as long as the products have the same risk-based classification.
- Category 2 and 3 changes cover changes in manufacturing facility, process and quality management system (QMS), the design or specifications of a registered medical device, the materials or labelling of medical devices or registration information.
- Please note there is no change to the fee structure, a fee is charged per change submitted no matter whether changes are combined or not. The combining of changes into one submission means the user can save time during the submission process.
- The MeDC@St 2.0+ will autogenerate a Letter of Change Notification signaling rejection or approval.
Device Study sub-module (under the Clinical Research module)
- Different types of notifications are now available under this sub-module.
- Notifications relating to a Device Study such as Adverse Event reporting and scheduled progress reports can be made online until completion of the Device Study.
- A Notification Letter can be downloaded and printed directly from the MeDC@St2.0+ account.
Clinical Research Use sub-module (under the Clinical Research module)
- A new online form is now available.
- A new structured subsequent notification process that allows notifications to be made repeatedly.
- A Notification Letter can be downloaded and printed directly from the MeDC@St2.0+ account.
Demonstration / Education Purposes module
- A new feature is available for the selection of the medical device category.
Payment Module
- Users can now pay via credit card in addition to the existing payment methods of bank draft and FPX.
- Under MeDC@St2.0+, the MDA will enforce a 30-day term for all payments; failing which, the application will be automatically dropped from MeDC@St2.0+, and the establishment will have to make a fresh application.
More information:
Click here to read the announcement on Medcast 2.0+ launch
If you have any queries regarding what the changes to Medcast 2.0+ mean for your product, please contact your Regulatory Affairs Specialist at Andaman Medical or click the button below.
To learn more about registering medical devices in Malaysia click here.
To learn more about the medical device market in Malaysia click here.