The Medical Device Authority (MDA) announced the applications for medical device re-registration must be submitted online using MeDC@St 2.0+, in accordance with the Guidelines for Re-Registration of Registered Medical Devices (MD/GL/08). One year prior to the certificate expiration date, the system will display a re-registration option enabling the establishments to submit their applications.
Applications for medical device re-registration must be submitted online using MeDC@St 2.0+, according to the Guidelines for Re-Registration of Registered Medical Devices (MD/GL/08). One year prior to the certificate expiration date, the system will display a re-registration option enabling the establishments to submit their applications.
As part of MDA's continuous improvement commitment, expired certificates will be automatically deactivated using the current system. If establishments do not re-register before the certificate expires, they must file a new registration application. For this reason, MDA advises all establishments to schedule their registration submissions and change notifications appropriately in order to prevent any unanticipated problems.
Recently, MDA has made significant improvements to the Medical Device Centralized Reporting System (MeDCReSt), an online platform for coordinating post-market medical device reporting. This upgrade aims to enhance the efficiency, security, and functionality of the system, providing a more seamless experience for all users.
In conclusion, staying informed about the latest regulatory updates in Malaysia's medical device sector is crucial for maintaining compliance and avoiding disruptions. We invite you to connect with us to discuss these updates in detail and explore how our services can support your regulatory needs in Malaysia. Reach out to Qualtech today to ensure your medical device registrations and reporting processes are streamlined and up-to-date.
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References:
- MDA advise Establishments to Submit Medical Device Re-Registration Applications in the Medc@st 2.0+ System One Prior to Certificate Expiration Date
- Upcoming Upgrade of MeDCReSt System