Maha FDA asks manufacturers to speed up Class A and B medical device Registration with CDSCO

Maha FDA asks manufacturers to speed up Class A & B medical device Registration with CDSCO.

As per the earlier notification of health and family welfare medical devices were under voluntary registration scheme. Medical devices has been classified under four categories class A, Class B, Class C, Class D. As per the new notification manufacturers are required to mandatorily register class A and Class B device with CDSCO by September 30, 2022.

It has come to the notice that a significant number of medical device manufacturers in the state are yet to register with the CDSCO,Maharashtra Food and Drug Administration taking a serious note on this and speeding up the process. Maha FDA pushes manufactures to speed up registration process of class A and B medical devices to avoid any actions.

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According to a circular issued by Maharashtra FDA recently, action will be initiated against the manufacturers of Class A and Class B medical devices for failing to register with the online portal of CDSCO within the stipulated time frame. The low risk to moderate risk devices classified under Class A and Class B medical devices. The class C and Class D medical devices will be under compulsory registration scheme up to September 2023. If the mandatory registration process not completed within time frame the action will be taken by the said department. Medical devices industry is now growing rapidly. CDSCO is the regulatory body for the medical devices in India .Depending upon the risk factor Medical devices are classified as Class A, Class B, Class C, Class D devices. Class A and Class B are low to moderate risk devices whereas Class C, and Class D are moderate to high risk devices. For Class A and Class B medical devices The State Licensing Authority Directs the manufacturing license. Today Indian medical device industry is growing rapidly, new opportunities ,new investors and governments initiatives will surely change the face of this industry in upcoming days .

References Link :http://pharmabiz.com/NewsDetails.aspx?aid=145823&sid=1

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