Hong Kong Medical Device Division Introduces Medical Device Information System

Hong Kong, with a population of 7.5 million people, is a good market for medical devices. While voluntary device registration is only required now, mandatory registration is on the horizon. Voluntary device registration is important since Hong Kong hospitals and clinics strongly prefer to buy devices on this voluntary list. In addition, once registered in Hong Kong, oftentimes medical device manufacturers can sell their devices to hospitals in the Greater Bay Area in China. Last month, the Medical Device Division (MDD) announced the launch of a new online platform, the Medical Device Information System (MDIS), set to go live on April 2, 2024. This innovative e-service platform is designed to streamline the process for the medical device industry, offering a centralized hub for the submission of online applications for device listing within Hong Kong’s Medical Device Administrative Control System (MDACS). In addition, it will provide a platform for reporting safety alerts and adverse events associated with medical devices.

To ensure a smooth transition from the traditional paper-based submission process to this new digital approach, the MDD has outlined a schedule for the rollout of MDIS’s e-services. Notably, from October 14, 2024 onwards, paper-based submissions will no longer be accepted, making it imperative for industry participants to switch over to the online system.

Local responsible persons (LRPs) and traders, including importers, distributors, and local manufacturers of medical devices should register for an account on the MDIS website at their earliest convenience. Early registration will allow users to gain firsthand experience with the system and familiarize themselves with the new e-service application process. Comprehensive training materials on how to use the MDIS system are available under the trader information page of the MDIS website, ensuring users are well-prepared to navigate the platform effectively.