​The processing time for Class IV medical device registration under Hong Kong's Medical Device Administrative Control System (MDACS) varies depending on several factors, including the completeness of the application and the complexity of the device. While specific timelines are not publicly detailed, the Medical Device Division (MDD) has established an Expedited Approval Scheme for Class II, III, and IV general medical devices.​

To apply for Class IV medical device registration under Hong Kong’s Medical Device Administrative Control System (MDACS), certain conditions must be met to ensure that your device complies with the regulatory framework and is eligible for registration. These conditions pertain to the device's classification, local representation, technical documentation, and prior approval in a reference country. Below are the key conditions that must be fulfilled:

To apply for Class IV medical device registration under Hong Kong’s Medical Device Administrative Control System (MDACS), you must follow a structured process administered by the Medical Device Division (MDD) of the Department of Health. Here's a step-by-step guide to how and where to apply:

For Class IV medical device registration under Hong Kong MDACS, the preparation of application materials is critical for a smooth and successful listing. Below is a complete guide on the materials needed and how to prepare each document.

Here's a comprehensive overview of the procedures, required documents, and key considerations for Class IV medical device registration under the Hong Kong Medical Device Administrative Control System (MDACS):

All applications for Class IV medical device listing under the Medical Device Administrative Control System (MDACS) must be submitted to the Medical Device Division (MDD) of the Department of Health, Hong Kong.

The cost and time required for Class IV medical device registration under Hong Kong’s Medical Device Administrative Control System (MDACS) depend on several factors, including the completeness of the application, the complexity of the device, and the current workload of the Medical Device Division (MDD).

Class IV devices are considered highest-risk medical devices under the Medical Device Administrative Control System (MDACS) in Hong Kong. While MDACS is voluntary, listing is required for participation in public hospital tenders and is often seen as a mark of compliance with international safety and performance standards.