Clinical Performance Evaluation for new In Vitro Diagnostic Medical Device

The permission to conduct clinical performance evaluation for new in vitro diagnostic medical device can be obtained by a sponsor on submitting an application in Form MD-24 to the Central Licensing Authority, along with a fee prescribed in the Second Schedule and the required documents. If the application complies with the statutory requirements, then the Central Licensing Authority will grant the permission in Form MD-25 or else, the application will be rejected within 90 days from the date of application, after giving an opportunity for explanation. No fee is required if the institute, organisation, hospital is run or funded by the Central Government or the State Government. In public interest, the Central Licensing Authority has the authority to abbreviate, defer, or waive the requirement of clinical performance evaluation.

The documents required were:  complete device description, in house performance evaluation data, performance evaluation report from Central Device Testing Laboratory, clinical performance evaluation plan, approval from the registered Ethics Committee, case report form and undertaking as prescribed in the seventh schedule, source and quantity of sample, duration of evaluation, laboratories participating in the study and an undertaking that the device conforms to the rules and adequate precaution has been taken to protect the health and safety of the subjects.

Conditions for conducting Clinical Performance Evaluation

The clinical investigation plan must be approved by the registered ethics committee before the start of clinical performance evaluation and registered with the clinical trial registry of India. The clinical performance evaluation must be conducted in accordance with the approved clinical performance evaluation plan and Good Clinical Practice Guidelines issued by the CDSCO. The study should be initiated within one year of obtaining the permission, failing which prior permission is required to start the study. The sponsor should submit the annual status report of the study to the Central Licensing Authority and in case if the study is terminated, then it should be reported within 30 days. The sponsor along with any person connnected with study is subjected to the inspection by the officers authorized by the Central Licensing Authority. Any additional conditions or exemptions, if any, imposed by the Central Licensing Authority while granting the permission has to be followed by the sponsor. In case of any injury to the subjects, the sponsor has to provide the medical management to the subject.

If the sponsor fails to comply with the conditions of permission, the Central Licensing Authority may suspend or cancel the permission either wholly or partly. The sponsor may appeal against such order to the Central Government within 30 days and the Government will dispose such appeal within 60 days.