Currently, there is NO official application fee charged by the Hong Kong Department of Health for listing Class B medical devices under MDACS.(This makes it more cost-effective compared to many other jurisdictions.)

To register a Class B medical device under the Hong Kong MDACS (Medical Device Administrative Control System), you must meet specific eligibility, documentation, and regulatory requirements set by the Medical Device Division (MDD) of the Hong Kong Department of Health.

The MDACS is a voluntary listing system for medical devices in Hong Kong, managed by the Medical Device Division (MDD) of the Department of Health. For Class B medical devices (low–medium risk), the process includes demonstrating compliance with recognized regulatory standards (e.g., EU, FDA, TGA, etc.) and appointing a Local Responsible Person (LRP).

Class B medical device registration under Hong Kong’s MDACS refers to the voluntary listing of low‐to‐medium risk medical devices in the Medical Device Administrative Control System (MDACS), which is operated by the Medical Device Division of Hong Kong’s Department of Health.

MDACS is a voluntary registration system managed by the Medical Device Division (MDD) of the Hong Kong Department of Health.

The time it takes to obtain Class A medical device registration under Hong Kong MDACS can vary, but generally, the process is relatively fast compared to higher-risk devices (Classes B, C, and D).

No, Class A medical device registration under Hong Kong MDACS does not require an annual review. The registration for Class A devices is typically valid for 5 years after initial approval. During this period, the device is not subject to routine annual reviews.

The purpose of handling Class A medical device registration under Hong Kong MDACS is to ensure that low-risk medical devices meet essential safety, quality, and performance standards before they are sold and used in the Hong Kong market. The Medical Device Administrative Control System (MDACS) provides a streamlined regulatory process designed to protect public health while allowing easier access to the market for low-risk devices.