Skip to main content

Posts

Showing posts with the label medical devices regulation India

Notice Regarding Classification Of Non-Notified Medical Devices (MD)

CDSCO or Central Drugs Standard Control Organization, the authority that regulates medical devices regulation India released two draft notices  on September 3, 2020. The draft notification  includes the classification of non-notified medical devices and in-vitro diagnostic devices. As per the new draft notice, it helps in classifying the medical devices into appropriate device class and map the efficient date for required device registration. All medical devices are under the regulation of CDSCO in a phase-wise manner and they should be registered in required timelines. Under new draft classification CDSCO has classified 1866 medical devices. The devices are divided into 24 categories. The devices are well examined and then classified based on internationally accepted classification and the first schedule of medical device rules, 2017. As per the regulation, based on risk classes medical devices are divided into 4 categories. Under each category, there is a specified number of m
Post a Comment
Read more