The Medical Device Division (MDD), formerly known as Medical Device Control Office (MDCO), was established in July 2004. The MDD is responsible for implementing the Medical Device Administrative Control System (MDACS) and developing a long-term statutory regulatory framework for medical devices.
The purpose of regulation is to ensure people in Hong Kong have timely access to medical devices that are safe, efficacious, and perform as intended on one hand, and to avoid unnecessary burden on the trade on the other. Therefore, the proposed regulatory regime for medical devices would adopt a risk-based approach whereby the level of control would be proportionate to the degree of risk classified for medical devices according to the recommended classification scheme of the International Medical Device Regulators Forum (IMDRF) (previously Global Harmonization Task Force (GHTF)).
To raise public awareness on the safe use of medical devices and enable traders to familiarise themselves with the future mandatory requirements, the government has launched a Medical Device Administrative Control System (MDACS) on 26 November 2004. The listed medical devices are posted on our website for the public's reference.