Scope

When asked to describe a medical device, many people tend to describe those complex, highly technical equipment used in acute healthcare facilities. However, medical devices cover a broad range of products, including highly complex and sophisticated products such as Magnetic Resonance Imaging System to simple products such as bandages and thermometers.

A medical device is defined as any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific medical purpose(s) of:

1. diagnosis, prevention, monitoring, treatment or alleviation of disease; or
2. diagnosis, monitoring, treatment, alleviation of or compensation for an injury; or
3. investigation, replacement, modification, or support of the anatomy or of a physiological process; or
4. supporting or sustaining life; or
5. control of conception (including contraception); or
6. disinfection of medical devices; or
7. providing information for medical purposes by means of in vitro examination of specimens derived from the human body;

and which does not achieve its primary intended action in or on the human body by pharmacological, immunological, or metabolic means, but which may be assisted in its intended function by such means.

Some products, notwithstanding that they fulfil the definition of medical devices, are not included into the current scope of the Medical Device Administrative Control System. Please refer to Clause 3.2.1 of the Guidance Notes GN-01 for details.