Understanding the Importance of Clinical Performance Evaluation for IVDS: Meeting Regulatory Expectations



Frequently Asked Questions

What is FORM MD-24?

Form MD 24 is an application form to get the grant or permission to conduct a performance evaluation of a new in-vitro diagnostic kit.

The study must be initiated within one calendar year of receiving the permission. If permission is not granted, it will need to be approved in advance. The sponsor should submit an annual status report on the study to Central Licensing Authority. If the investigation ends, it should also be reported within thirty days.

The permission to conduct clinical performance evaluation for a new in vitro diagnostic medical device is granted in Form MD-25 by the Central Licensing Authority.

Any medical device or new in vitro diagnostic medical device imported or manufactured, for the purpose of clinical investigation or clinical performance evaluation, test, evaluation, demonstration and training, shall be kept in containers bearing labels, indicating the name of the product or code number, batch or lot number, serial number wherever applicable, date of manufacture, use before date, storage conditions, name and address of the manufacturer, and the purpose for which it has been manufactured.

Clinical performance evaluation in India are typically only required for risky IVD (Class B, Class C and Class D) without predicates and may also be required for Class A IVD’s.

Clinical performance evaluation is the systematic performance assessment of an in vitro diagnostic medical device using a specimen taken from humans to evaluate its performance.IVD Clinical investigation is the ability of the diagnostic kit to perform its intended function as claimed by the manufacturer. It includes the analytic and, where applicable the clinical performance that supports the intended purpose.

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