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Classification of Medical Devices in USA
Medical devices in USA are classified by CDSCO, Central Licensing Authority. Medical device other than in-vitro diagnostic medical devices are classified on basis of: Risk, Intended purpose, Duration of contact, Invasiveness- non-invasive, invasive with respect of body orifice, surgically invasive.
Notified Device : Notified medical devices are the once which require registration CDSCO has published a list of notified medical devices and In vitro diagnostic devices which are regulated by CDSCO and for which license to import, manufacture, sale and distribution can be obtained.
Non-Notified Device : As per CDSCO, no registration is required for import or manufacturing of non-notified devices. However, these are regulated as drugs under drugs and cosmetics act and rules.
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