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 medical devices. Underclass A risk class, there are 485 medical device airway protection face mask, microbial incubator, then under class B, there are 779 medical devices like telemetric diagnostic spirometer, microarray analyzer, class C contains 506 medical devices like oxygen breathe analyzer, contraceptive spermicide and class D comprises 83 medical devices like PCR analyzer, Fetal cardiac monitor etc.
All medical devices under low-risk class A and moderate class B should get registered with CDSCO by August 2022 while class C and Class D medical devices that come under high-risk devices must be registered by August2023. CDSCO was accepting all comments from every stakeholder of the industry like the manufacturers and associations till October 3, 2020, and for any doubts and advice, stakeholders are asked to consult a regional regulatory expert.
Earlier 37 medical devices were under the regulation of CDSCO and the present draft notification offered a classification of non-notified medical devices that falls under the definition of medical devices in coming days. All medical devices industries must check whether or not their products come in the list provided and then make all required arrangements in respect to required documents for registration.