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

The MDD implements 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.