Definition of Medical Device as per MDR 2017
Objective of Medical Device
Medical Devices are widely used in all branches of medicines, surgery and community not only in India but across the globe. To keep in view, the broad objectives is to ensure protection of health & safety of patients, healthcare professionals and others, the Ministry of Health & Family Welfare, Government of India has released the Medical device Rules, 2017 effective from 1st January, 2018 for regulating Medical Devices being used in the Country .
Medical Device Definition as per Medical Device Rules 2017
Medical Device means
1. Any substances used for in vitro diagnosis and surgical dressings, surgical bandages, surgical staples, surgical sutures, ligatures, blood and blood component collection bag with or without anticoagulant. (All medicine for internal or external use of human beings or animals and all substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings or animals including preparations applied on human body for the purpose of repelling insects like mosquitoes.)
2. Any Substances including mechanical contraceptives (condoms, intrauterine devices, and tubal rings), disinfectants and insecticides (substances, other than food, intended to affect the structure or any function of the human body or intended to be used for the destruction of insects which cause disease or disorder in human beings or animals.)
3. Any devices intended for internal or external use in the diagnostics, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified from time to time by the Central Government.
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