Feb 4, 2022

The Malaysian Medical Device Authority (MDA) has launched a new version of its electronic medical device registration system with improved features and functionality for applicants.

The MeDC@st 2.0 system includes several new and enhanced features for Malaysian market registrants, including:

  • A new Change Notification Module with allowances for applications for single and multiple submission identification numbers
  • New features under the Clinical Research Module for various notification types, including Adverse Event Reporting and Scheduled Progress Reports
  • Tools to automatically generate Notification and Change Notification letters for printing by applicants
  • A new credit card payment option

The MDA plans to publish a Frequently Asked Questions (FAQ) document regarding MeDC@st2.0 in mid-February 2022.

Learn more about Malaysian medical device registration and approval at Emergo by UL:

 

Author

  • Stewart Eisenhart

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