To register a Class III medical device under MDACS (Medical Device Administrative Control System) in Hong Kong, a structured set of documents is required. Below is a complete breakdown of the required documents and how to prepare the application files.

Here is a complete guide outlining the process, required documents, and key considerations for registering a Class III medical device under the Medical Device Administrative Control System (MDACS) in Hong Kong:

To apply for Class III medical device MDACS registration in Hong Kong, the application must be submitted to the Medical Device Division (MDD) of the Department of Health (DH).

As of now, MDACS registration is voluntary and free of charge.The Medical Device Division (MDD) of Hong Kong's Department of Health does not charge fees for:

To register a Class III medical device under the Medical Device Administrative Control System (MDACS) in Hong Kong, you must comply with the requirements set by the Medical Device Division (MDD). Below are the key requirements:

Here is a detailed breakdown of the procedures and steps for registering a Class III medical device under MDACS in Hong Kong:

Class III medical devices under Hong Kong’s Medical Device Administrative Control System (MDACS) are high-risk medical devices, such as:Implantable devices (e.g., pacemakers, orthopedic implants),Life-supporting or life-sustaining equipment (e.g., ventilators).

To apply for Class III medical device MDACS registration in Hong Kong, you must follow the guidelines set by the Medical Device Administrative Control System (MDACS), operated by the Medical Device Division (MDD) under the Department of Health (DH). Here’s a step-by-step overview of the process: