ABSTRACT
The regulatory information contained in this report is intended for market planning and is subject to change frequently. Medical device regulation is developing in Hong Kong. The new regulatory system will largely be based on the recommendation of the Global Harmonization Task Force (GHTF). The Consumer Goods Safety Ordinance provides protection against the supply, manufacture, or import of unsafe products, including some medical devices that can be regarded as consumer goods, unless otherwise specified in the schedule. The statutory regulation of certain health care professionals, whereby practitioners are required to ensure the safe and appropriate treatment for patients, also provides incidental control on the use of medical devices. 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 diseases or injuries; or for rehabilitation purposes; or for the purposes of investigation, replacement or modification of body structure or function.
