To register a Class A medical device under Hong Kong’s MDACS (Medical Device Administrative Control System), you need to prepare and submit a complete set of documents to the Medical Device Division (MDD). Below is a full breakdown of the required materials and how to prepare each application document.

Here’s a complete guide to the procedures, required materials, and important notes for handling Class A medical device registration under the Hong Kong Medical Device Administrative Control System (MDACS)

To apply for Class A medical device registration under the Hong Kong Medical Device Administrative Control System (MDACS), the application must be submitted to the Medical Device Division (MDD) of the Department of Health.

As of 2025, the Medical Device Administrative Control System (MDACS) operated by the Hong Kong Department of Health is a voluntary system, and the registration of Class A medical devices is free of charge.

To handle Class A medical device registration under the Hong Kong Medical Device Administrative Control System (MDACS), you must meet specific regulatory, procedural, and documentation requirements. Below is a comprehensive guide to those requirements.

The Medical Device Administrative Control System (MDACS) is a voluntary regulatory system implemented by the Medical Device Division (MDD) of the Hong Kong Department of Health to monitor the safety and quality of medical devices marketed in Hong Kong. Class A devices are considered low-risk and follow a streamlined registration process compared to higher-risk classes (B–D).

Under the Medical Device Administrative Control System (MDACS) in Hong Kong, medical devices are classified into Classes A, B, C, and D according to risk level, with Class A representing the lowest risk.

In Hong Kong, medical device registration is overseen by the Medical Device Division (MDD) of the Department of Health, under the Medical Device Administrative Control System (MDACS). Though registration is voluntary (as of now), it is strongly recommended, especially for public procurement and private healthcare institutions.