Medical devices generally refer to products having a medical purpose(s) and range from sophisticated equipment such as cardiac pacemakers used by health care professionals to simple products such as bandages and thermometers bought over the counter by the public.In essence, a medical device refers to any instrument, apparatus, appliance, material or other article, excluding drugs, used for human beings for diagnosis, prevention, treatment, monitoring of disease or injuries; or for rehabilitation purposes; or for the purposes of investigation, replacement or modification of body structure or function. In addition, it includes devices used for examination of human specimens for the purposes of diagnostic, monitoring and compatibility in the forms of reagents, calibrators, control materials, specimen receptacles etc. which are categorised under in vitro diagnostic medical devices.An accessory to a medical device is subject to the same regulations that apply to the medical device itself. However, devices designed for the treatment or diagnosis of diseases and injuries in animals are outside the scope of medical device under the Medical Device Administrative Control System.For more details, please refer to the full definition of medical device recommended by the International Medical Device Regulators Forum (IMDRF) (previously Global Harmonization Task Force (GHTF)).

Please refer to the Department of Health’s webpage: https://www.mdd.gov.hk/tc/mdacs/online-tools/is-your-product-a-medical-device/index.html

Currently, there is no specific legislation that regulates the manufacture, import, distribution, supply and use of medical devices in Hong Kong. However, depending on the nature and characteristics of the products concerned, some products may be regulated by existing pieces of legislation such as the Pharmacy and Poisons Ordinance (Cap 138), the Radiation Ordinance (Cap 303), and the Telecommunications Ordinance (Cap 106).

Following are the major problems identified at present :No pre-market control to assess the safety, performance and quality of medical devices to safeguard public health;No formal post-market surveillance system including adverse event reporting; andInadequate product information for the public and operators to make informed choices on the safe use of medical devices.In view of the above, there is a need to develop an appropriate regulatory system to control the supply of medical device in Hong Kong.

The Department of Health should strike a balance between providing consumers with sufficient choice and offering the community medical devices that perform safely, efficaciously and as intended. The Government is aware of the potential cost implication to the trade and users of medical device. Therefore, the Department of Health propose a cost-effective, risk-based regulatory approach with reference to harmonised international standards recommended by the relevant international authority – International Medical Device Regulators Forum (IMDRF). The degree of control will be relative to the level of risk associated with a device.

A statutory control framework for medical devices is being developed by the Government to ensure that medical devices are safe, of good quality, and can perform as intended before they are allowed to be placed on the local market. 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 the voluntary Medical Device Administrative Control System (MDACS) since November 2004. The listing of medical devices and traders, and the Conformity Assessment Body (CAB) Recognition Scheme were implemented in phases. The MDACS covers Classes II to IV (medium to high risk) general medical devices, Classes B to D (medium to high risk) in vitro diagnostic medical devices, local manufacturers, importers, distributors and CABs. The MDACS has the same scope as that of the proposed legislative control framework. Information on the listed medical devices and listed traders can be found on the Department of Health’s website.

Many regions and countries like Australia, Canada, Europe, Japan and the United States of America already have their own systems for the control of medical devices. Asia-Pacific countries such as China, Indonesia, Malaysia, Philippines, Singapore, South Korea and Thailand also operate their own systems to regulate medical devices.

International Medical Device Regulators Forum (IMDRF) (previously Global Harmonization Task Force (GHTF)) is a voluntary group of medical device regulators from around the world who have come together to build on the strong foundation work of the GHTF, and to accelerate international medical device regulatory harmonisation and convergence. IMDRF members include Australia, Brazil, Canada, China, Europe, Japan, Russia, Singapore, South Korea and the United States of America.