Medical device field involves medicine, machinery, electronics, plastics and other industries, it is a multidisciplinary, knowledge-intensive, capital-intensive high-tech industry. there are thousands of medical devices, from a small piece of gauze to a big set of MRI machine, it is very easy to see especially when we are in hospitals or clinics. So what is a medical device?According to GHTF/SG1/N071:2012,5.1,The definition of medical device is as below:
Instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, 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:
-Diagnosis, prevention, monitoring, treatment or alleviation of disease; such as digital thermometer, blood pressure monitor, aneroid sphygmomanometer, stethoscope, nebulizer, fetal doppler;
-Diagnosis, monitoring, treatment, alleviation of or compensation for an injury; such as Artificial ligament, artificial meniscus, Gynecological infrared therapy instrument;
-Investigation, replacement, modification, or support of the anatomy or of a physiological process; such as denture,Joint prosthesis;
-Supporting or sustaining life; such as emergency ventilator, Cardiac pacemaker;
-Control of conception; such as latex condom, Contraceptive gel;
-Disinfection of medical devices; such as ethylene oxide sterilizer, steam sterilizer;
-Providing information by means of in vitro examination of specimens derived from the human body; such as pregnancy test, COVID-19 nucleic acid reagent;
And does not achieve its primary intended action by pharmacological,immunological or metabolic means, in or on the human body, but which may be assisted in its intended function by such means.
Please note products which may be considered to be medical devices in some jurisdictions but not in others include:disinfection substances; aids for persons with disabilities; devices incorporating animal and/or human tissues; devices for in vitro fertilization or assisted reproduction technologies.
Post time: Feb-13-2023