ESTABLISHMENTS ARE ADVISED TO SUBMIT MEDICAL DEVICE RE-REGISTRATION APPLICATIONS IN THE MeDC@St 2.0+ SYSTEM ONE YEAR PRIOR TO CERTIFICATE EXPIRATION DATE

According to the Guideline for Re-Registration of Registered Medical Devices (MD/GL/08), medical device re-registration applications must be filed through the online application system, MeDC@St 2.0+. The re-registration button will appear in the system one year before the certificate expiration date, allowing establishments to submit the applications.

In line with MDA’s commitment to provide continuous improvement, the current system will automatically deactivate expired certificates. Establishments shall submit a new registration application if they fail to submit a re-registration application before the certificate expires.

Therefore, MDA encourages all establishments to plan their registration submissions and change notifications accordingly to avoid any unforeseen issues during the submission process.

Thank you.

Pre-Market Control Division
Medical Device Authority
Ministry of Health Malaysia
17th May 2024