Department of Health | Medical Device Division - Medical Device Information System

The Medical Device Division has introduced a new Medical Device Information System (MDIS) on 2 April 2024, 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 are set out in the table below. Please kindly be informed that paper-based submissions will not be accepted after 14 October 2024:

The key dates of rollout of e-services of MDIS
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

Local responsible person (LRP) and Traders (including importers, distributors and local manufacturers of medical devices) are encouraged to visit our MDIS website 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. To understand how to use MDIS, please refer to the training materials for Medical Device Information System (MDIS) under the trader information page.

Should you require any assistance, please do not hesitate to contact our 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.

Medical Device Information System

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