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:
- Malaysia MDA medical device registration consulting
- Malaysia Authorized Regulatory Representation in-country representation
- Whitepaper: Registering a medical device with the Malaysian Medical Device Authority
Author
- Stewart Eisenhart