Investigational New Device/ New Device – First Time In India
Investigational New Device/ New Device – First Time In India
A medical device whose predicate or similar device is not available in India is considered to be an investigational / new medical devices. Such devices need to be investigated by conducting a clinical investigation on human participants in India. The clinical investigation is meant to demonstrate the safety, performance and effectiveness of the medical device on humans.
Once this clinical investigation has been completed, the application for manufacturing or importing the medical device has to filed at the Central Licensing Authority.
It is important to note here that Class A and Class B medical devices do not need to undergo a clinical investigation. Whereas Class C and D medical devices which do not have a free sale certificate in GHTF (US, Canada, EU, Japan & Australia) countries are required to undergo a clinical investigation due to the risk involved with their use.
For medical devices which are required to undergo a clinical investigation, a permission to conduct the clinical investigation for the medical device has to be filed at the CLA using form MD-23.
The Clinical Investigation involves voluntary human participants who have allowed the new medical device to be used over them. The Clinical Investigation performed on these human participants derives reports and other test data which describe about the effectiveness of the new medical device.
The report also describes the safety measures to be taken when using the medical device as well as the risks associated with using the device.
The trained and experienced staff at CliniExperts helps you in creating, reviewing and submitting an application in the proper format to the Central Licensing Authority. Thus improving your chances and time of approval.
Once the Clinical investigation has been completed, the applicant needs to submit an application for importing or manufacturing the new medical device. This application has to be filed at the Central Licensing Authority.
The application consists of a cover letter along with supporting documents describing the outcomes of clinical investigations and other relevant supporting data. The application fees for each category of the medical devices is different.
Our team of experts focuses upon the quality attributes as well as on the scientific perspective of the new medical device, helping you to craft an immaculate application for submission at the CLA. Thus improving your chances of approval.
Permission to conduct Clinical Investigation for Investigational Medical Device (Form MD-23)
Clinical investigation is mandatory to be conducted for Class C and Class D devices. However, an applicant can file an application to conduct clinical investigation on devices of any class. An application for the clinical investigation of a medical device has to be filed at the Central Licensing Authority (CLA).
We at CliniExperts help our clients in filing the applications and obtaining a clinical investigation license in hassle free manner.
Permission to import/manufacture medical device without predicate device (Form MD-27)
Licensing of Class A (Low risk) and Class B (Low to Moderate Risk) devices falls under the jurisdiction of State Licensing Authorities. CliniExperts has a vast network of offices and associates in all Indian states to help the manufacturer in filing an application with the respective state FDA authority. Our team will help you in obtaining, filling and the submission of appropriate forms for obtaining manufacturing or loan license permission.
For more information on any of the above services or any query, please feel free to reach us at contact@cliniexperts.com or +91-767 20 05 050