Permission to conduct Clinical Performance Evaluation in India – MD-24 & MD-25


ENQUIRE NOW


    CliniExperts is backed by a well-informed and experienced team who guides through all the documentation and paperwork required for the regulatory processes. They will also assist you in obtaining the Grant of Permissionto conduct a Clinical Performance Evaluation of anew In-vitro Diagnostics in Form MD-25.

    Permission to conduct Clinical Performance Evaluation– Overview


    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.

    • The applicant needs to make an application to the Central Licensing Authority.
    • The application can be filed in FORM MD-24 through an identified online Medical Device portal of the Ministry of Health and Family Welfare.
    • The Permission to conduct a Clinical Performance Evaluation will be obtained in FORM MD-25.
    • The approval is a Government process and could take approximately 1 to 2 months.

    What is MD-24 and MD-25

    Form Names

    MD-24

    It is an application form for the Grant of Permission to conduct a Clinical Performance Evaluation.

    MD-25

    It is the Permission to conduct a Clinical Performance Evaluation of a new in-vitro diagnostics.

    Who Can Apply?


    Any manufacturer or importer who wishes to conduct a Clinical Performance Evaluation of new IVD can make an application to the Central Licensing Authority.


    How To Apply?

    Any manufacturer or importer who wants to conduct a Clinical Performance Evaluation of new IVD's can apply through the following procedure:
    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.

    Fee Involved

    The Government charges specific fees of 25000 INR for obtaining Permission to carry out a Clinical Performance Evaluation of a new In-Vitro Diagnostic (IVD's).

    Validity

    The license validity for this service is not applicable.

    Important Documents

    The essential documents required for this service are: Undertaking by investigators Approval from the Ethics Committee Clinical Performance Evaluation plan In-house Performance Evaluation data (used to establish sensitivity, specificity, stability, reproducibility and repeatability).

    Timeline to get Form MD-25 from Central Drugs Standard Control Organisation

    Essential Tips

    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.

    Expert Advise

    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.

    Related Services

    Frequently Asked Questions

    What is a new In-vitro Diagnostics (IVD's)?

    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.

    Is clinical performance evaluation required for grant of Permission to manufacture or import a new IVD of Class A?

    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.

    Is CDSCO capable of cancelling or suspending the grant of Permission?

    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.

    If the approval or marketing authorisation is issued by the competent Authorities in Canada, Japan, E.U., U.K., Australia, and the USA, will it be considered for exemption of Clinical Performance Evaluation of New IVD's (Class B, C and D) in India.

    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.

    What are the minimum criteria for evaluation of IVD Kits or reagents intended for Chikungunya, Typhoid, Malaria, T.B., Dengue, Cancer, Syphilis and other Class B and C IVD kits?

    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.

    Call Now