The Central Licensing Authority, CDSCO, is the regulatory body associated with this service.
This service aims to obtain Permission to conduct a Clinical Performance Evaluation of all new in-vitro diagnostics (IVDs).
A manufacturer or an importer who intends to conduct a Clinical Performance Evaluation of a new In-vitro diagnostic can apply through this service.
Any manufacturer or importer who wishes to conduct a Clinical Performance Evaluation of new IVD can make an application to the Central Licensing Authority.
|Step 1: The application for the Grant of Permission to conduct a Clinical Performance Evaluation of anew IVD can be made in Form MD-24.|
|Step 2: The application should address to the Central Licensing Authority, CDSCO.|
|Step 3: The application should be submitted along with the required documents and the specified fees on the online SUGAM portal.|
|Step 4: The reference regulation for this service is the Medical Device Rules, 2017.|
The license validity for this service is not applicable.
CliniExperts has some essential tips that might benefit their clients.
The applicant must have an undertaking from investigators.
The Clinical Performance Evaluation plan should clearly state the purpose, scientific, technical or medical grounds and scope of the evaluation.
The applicant must possess approval from an Ethics Committee registered with the Central Licensing Authority.
A few problems can be faced if the following points are left unchecked during the application process:
The applicant must register the Clinical Performance Evaluation with the Clinical Trial Registry of India prior to enrolling the first participant for the Clinical Performance Evaluation.
The Clinical Performance Evaluation plan must be initiated only after the registered Ethics Committee approves.
The Clinical Performance Evaluation should be conducted per the guidelines of Good Clinical Practices and the approved Clinical Performance Evaluation plan.
CliniExperts provides sure advice to their clients-
The applicant must have approval from the Ethics committee.
The Clinical Performance Evaluation needs to be initiated within one year from the date of grant of Permission; if failed, prior Permission from the Central Licensing Authority will be required to start such Clinical Performance Evaluation.
During the evaluation, the source and quantity of samples need to be known.
A new in-vitro diagnostic is any Medical Device mentioned in sub-clause (A) of clause (zb), which is intended to be used for in vitro diagnostics. The device may not be approved for manufacture, sale, or import by the Central Licensing Authority. It is only being tested to establish its performance for relevant analyse or other parameters, including the required details of technology and procedure.
No. The Clinical Performance Evaluation may not be necessary; if otherwise, the Central Licensing Authority decides it is necessary depending on the nature of the IVD.
The Central Licensing Authority, CDSCO, may suspend or cancel the grant of Permission if the manufacturer or the importer fails to comply with any of the conditions of the Permission. In addition, CDSCO may partly or entirely cancel the Permission or suspend it for a particular period.
No. The Clinical Performance Evaluation (CPE)will not be exempted. The CPE should be conducted in India to approve new IVDs, irrespective of their regulatory status in other countries.
The minimum performance criteria of IVDs like clinical specificity, sensitivity, repeatability, accuracy, reproducibility, linearity, variance, etc., should follow the manufacturer's claim in the product insert, IFU and COA.