MDD (Medical Device Division)

The Medical Device Division (MDD), previously known as the Medical Device Control Office (MDCO), is the medical device regulatory authority in Hong Kong.

The MDD operates the Medical Device Administrative Control System (MDACS), a voluntary listing mechanism designed to ensure that medical devices available in Hong Kong are safe, effective and perform as intended. Under a risk‑based classification scheme based on IMDRF classification principles, manufacturers are encouraged to list medium‑ and high‑risk medical devices, even though statutory regulation is still pending. Through MDACS, the MDD increases public awareness of safe device use, publishes listing information for transparency, oversees post-market vigilance such as adverse event reporting and recalls, and contributes to planning for future mandatory regulatory structures.

When was the MDD established?

MDD was established in July 2004 within Hong Kong’s Department of Health.

Does the MDD charge fees for medical device regulatory activities?

No, the MDD does not charge fees for medical device regulatory review, as device listing is currently voluntary in Hong Kong.

What key medical device regulations does the Hong Kong MDD enforce?

There is no regulatory framework in Hong Kong under the MDD as medical device listing is voluntary. However, MDD does issue Guidance Notes and Technical Reference documents that outline the listing process and its requirements, classification rules, post-market surveillance requirements, etc.

How can I contact the MDD?

The MDD can be contact via the form on their website. They can also be contacted via email or phone.

Website: MDD
Address: Room 604, 6/F, 14 Taikoo Wan Road, Taikoo Shing, Hong Kong
Phone: 3107 8484
Email: mdd@dh.gov.hk