Medical Device Division (MDD)

What is the Medical Device Division (MDD)? The Medical Device Division (MDD), previously known as the Medical Device Control Office (MDCO), was established in July 2004 within Hong Kong’s Department of Health. It serves as the territory’s designated regulatory body for medical devices, tasked with safeguarding public health through the development of a long-term statutory framework for device oversight and the implementation of interim administrative controls. What does the MDD do? 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, efficacious, and perform as intended. Under a risk‑based regime guided by 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.