Introduction of Medical Device Information System (MDIS) for listing of medical devices and traders
2024-04-05
Medical Device Division is pleased to announce that the Department of Health (DH) is going to introduce a new e-service on 2 April 2024, the MDIS, which will offer 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.
To facilitate smooth transition from paper-based to online submission of the application, the key dates of rollout of e-services of MDIS and the corresponding phasing out of paper-based submissions are set out in the table below. Please kindly be informed that paper-based submission will not be accepted after 14 October 2024:
E-Service Phase-out date of paper-based submissions Account Registration Application for the Listing of Class II/III/IV General Medical Devices
Application for the Listing of Class B/C/D In Vitro Diagnostic Medical Devices (IVDMD)
Application for Inclusion on the List of Importers/Distributors
Application for the Listing of Local Manufacturers Change Application for Listed Medical Devices
Takeover Application for Listed Medical Devices
Renewal Application for Listed Medical Devices
Renewal and Change Application for Listed Importers/Distributors
Renewal and Change Application for Listed Local Manufacturers
Medical Device Adverse Event Report Form – for Medical Device Users
Medical Device Adverse Event Report Form – for Local Responsible Persons
Medical Device Safety Alert Report Form Application for recognition under the Conformity Assessment Body (CAB) Recognition Scheme
Application for certification to National Medical Products Administration (NMPA)
Local responsible person (LRP) and Traders (including importers, distributors and local manufacturers of medical devices) are encouraged to visit the MDIS website (https://mdis.mdd.gov.hk) to register as account users as soon as possible, so as to get first-hand experience and become familiar with the upcoming application for listing using our new e-service. In addition, the latest updates and events related to MDACS can also be obtained by downloading the DH's official digital platform, @DH App. You can download the app on your mobile device by scanning the provided QR code (attached).
Should you require any assistance, please do not hesitate to contact dedicated MDIS technical support team at 3702 5356 or via email at mdis_support@nexify.com.hk. For general inquiries regarding applications under MDACS, please get in touch with the Medical Device Division of the Department of Health at 3107 8484 or via email at mdd@dh.gov.hk.
Thank you for your unfailing support in the successful launch of the one-stop e-service for the industry.
