Medical Device Information System

The Department of Health (DH) has introduced a new Medical Device Information System (MDIS), which offers a one-stop e-service for the industry to submit online applications for listing of medical devices (MDs) and traders under the Medical Device Administrative Control System (MDACS), as well as to report safety alerts and adverse events related to MDs. This new e-service has replaced the traditional approach of paper-based submissions after an 8-month parallel run to facilitate adaptation by the industry.

Users can simply access the MDIS using iAM Smart to submit online applications for the listing of new MDs and traders. They can enjoy greater convenience and efficiency in managing their applications brought by the following features of the MDIS:

• A to-do list of follow-up actions required for the submitted applications
• An overview of the status and results of the applications
• Email notifications on updates to the application status
• An online channel for instant communication with DH’s reviewing officers
• Downloading of electronic listing documents upon approval of applications

Furthermore, MD traders can centrally manage their listed MDs on MDIS and report safety alerts and adverse events related to their MDs promptly via MDIS to facilitate DH to conduct assessment and subsequent monitoring work. The roll-out of MDIS not only brings convenience to the industry but also supports DH in implementing MDACS in a more effective manner.

For more details, please click here to visit MDIS thematic page at the website of Medical Device Division, Department of Health.