Permission to Conduct Clinical Performance Evaluation for New In-Vitro Diagnostic (Form MD-25)

Permission to Conduct Clinical Performance Evaluation for New In-Vitro Diagnostic (Form MD-25)

According to new Medical Device Rules, 2017 any new in vitro diagnostic medical device” means any medical device as referred to in sub-clause (A) of clause (zb) used for in vitro diagnosis requiring approval for manufacture for sale or for import by the Central Licensing Authority has to undergo testing in order to establish its clinical performance for relevant analyse or other parameter related there to including details of technology and procedure are required as a part of submission of the application for the registration of such IVD’s.We at CliniExperts, help in the initiation and management of a clinical investigation or clinical performance evaluation in India.

An application for the grant of permission to conduct, clinical performance evaluation of new in vitro diagnostic medical device shall be made to the Central Licensing Authority in Form MD-24 by the sponsor and shall be accompanied with a fee as specified in the Second Schedule along with information specified in sub-rule (3) duly signed by the sponsor in India. Provided that no fee shall be required to be paid by the institutes, organisation, hospitals, run by the Central Government or the State Government, involved in conduct of clinical performance evaluation of new in vitro diagnostic medical devices.

The application for conducting Clinical Performance Evaluation for New In-Vitro Diagnostic should include the following information:

• Ethical Committee Approval;
• Source and quantity of samples which shall be used during evaluation;
• Device description including specification of raw material and finished product, data allowing identification of the device in question, proposed instruction for use, labels and regulatory status in other countries, if any;
• In house performance evaluation data used to establish stability, specificity, sensitivity, repeatability and reproducibility
• Clinical performance evaluation plan stating in particular the purpose, scientific, technical or medical
  grounds and scope of evaluation;
• Case Report Form as specified in Table 6 of the Seventh Schedule;
• Undertaking by investigators as specified in Table 9 of the Seventh Schedule;
• The list of laboratories or other institutions taking part in the evaluation study;
• The scheduled duration for evaluation and, in case of devices for self-testing, the location and number of lay persons involved;
• An undertaking that the device in question conforms to the requirements of these rules, apart from
  aspects covered by evaluation and apart from those specifically itemised in the undertaking, and that
  every precaution has been taken to protect the health and safety of the patient, user and other persons;
• Performance evaluation report from a laboratory designated under sub-rule (1) of rule 19.

After the scrutiny of the documents if the Central Licensing Authority, after any further enquiry, if any, is satisfied that the requirements of these rules have been complied, may grant permission to conduct clinical performance evaluation for a new in vitro diagnostic medical device in Form MD-25 or may reject the application, for reasons to be recorded in writing, within a period of ninety days from the date of application.