The landscape of medical device regulation is evolving rapidly. The Medical Device Information System (MDIS) is a system that regulates the way medical devices are listed and monitored in the region. The MDIS system has been made to adapt to the changing needs of the industry and provide a platform for medical device management. This article aims to provide information on the newly introduced MDIS.

The New MDIS: A One-Stop E-Service
On 2 April 2024, Hong Kong Medical Device Information (HK MDD) launched MDIS. This system offers a one-stop e-service for the industry, allowing online applications for the listing of medical devices and traders under the Medical Device Administrative Control System (MDACS). The system also enables the reporting of safety alerts and adverse events related to medical devices.

Key Rollout Dates of E-Services of MDIS
The rollout of the e-services of MDIS follows a detailed timeline. Along with it, the phase-out date of paper-based submissions of each service has also been announced, and thus will mark the complete transition to the digital platform.

Launch date	E-Service	Phase-out date of paper-based submissions
2 April 2024	Account Registration
15 April 2024	Application for the Listing of Class II/III/IV General Medical Devices (MD101) Application for the Listing of In Vitro Diagnostic Medical Devices (IVDMD) (MD102) Application for Inclusion on the List of Importers/Distributors (MD-IP+D) Application for the Listing of Local Manufacturers (LM)	17 June 2024
15 July 2024	Change Application for Listed Medical Devices (MD105) Takeover Application for Listed Medical Devices (MD110) Renewal Application for Listed Medical Devices (MD-Renewal) Renewal and Change Application for Listed Importers/Distributors (MD203) Renewal and Change Application for Listed Local Manufacturers (MD204) Medical Device Adverse Event Report Form – for Medical Device Users (AIR-USER) Medical Device Adverse Event Report Form – for Local Responsible Persons (AIR-LRP) Medical Device Safety Alert Report Form	16 September 2024
14 October 2024	Application for recognition under the Conformity Assessment Body (CAB) Recognition Scheme (CAB-AA) Application for certification to National Medical Products Administration (NMPA) (MD107)	14 October 2024

Getting Started with MDIS: Registration

MDIS offers two levels of user accounts: External Trader User (ETU) and External Individual User (EIU). Each user role has specific functions and responsibilities within the system. ETUs are responsible for maintaining Individual User Accounts, overseeing pre-market applications and post-market cases of all Individual Users, and perform reassignment of applications in case of staff turnover. In order to create an ETU account, a valid BR certificate is required. Whereas for EIU, a valid Trader User Account must be available. EIU’s role in the system is to perform e-submission of premarket applications, e-report of post-market cases, and as the direct contact during application processing stage. Find out more on the flow details of MDIS account registration right here.
As MDIS provides a platform for submitting online applications, the two user accounts also provide different functionalities to assist the applications. The features of each one are generally summarized as below, in which the detailed flow of Listing Application can be found in the following link.

Functionalities in Trader User Interface
The Trader User Interface in MDIS provides a range of functionalities. These include a dashboard that provides an overview on application status and statistics, notifications inbox, and other features that enhance the user experience.

Functionalities in Individual User Interface
The Individual User Interface in MDIS also offers a variety of functionalities. These include a platform to submit or withdraw application forms, a To-do list that provides an overview of the tasks requiring further actions including inquiries from MDD, providing the approved e-Certificate, and other features that streamline the user’s tasks.

Keeping up with the Updates
The introduction of the new MDIS has marked a significant milestone in Hong Kong medical device industry. The system’s robust functionalities and user-friendly interface have made it an invaluable tool for industry. We highly encourage Local Responsible Persons (LRP) and Traders (including importers, distributors and local manufacturers of medical devices) to visit the MDIS website and register as account users as soon as possible, familiarizing with the upcoming application for listing using the new e-services.
 

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References:

• Medical Device Division - Medical Device Information System (MDIS)
• Materials on MDIS - Account Registration (mdd.gov.hk)
• Materials on MDIS - Application for New Listing (mdd.gov.hk)