Pharmaceutical manufacturers often require to test and investigate the outcomes of a new medical device. Such devices are known as ‘investigational medical devices’. Such devices need a clinical investigation to be conducted on human subjects to infer the effectiveness and safety of the device.
An application to obtain permission for conducting clinical investigations for an investigational medical device must be filed to the Central Licensing Authority.
The application has be filed using form MD-23 by a sponsor on behalf of the company. Investigational medical devices can fall under either of the categories, namely Class A, Class B, Class C and Class D. Application for medical devices belonging to any of these categories must be filed at the Central Licensing Authority.
All medical devices whose predicate or similar medical device is not available in India must undergo a Clinical investigation on human participants. This is done to demonstrate the safety, effectiveness and performance of the device on human participants, proving it to be safe and viable for use.
Once the clinical investigation is successfully completed for these new medical devices, an application for manufacture or import of the device is to be filed at the Central Licensing Authority along with the investigation reports.
The application filing process is quite cumbersome and seeking the help of experts is a viable option.
At CliniExperts, we help our clients to file the application for an investigational medical device and obtain a license with minimal effort and within the quickest possible time.
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