Current Regulatory Scenario for Conducting Medical Device Clinical Trials in India · Cliniexperts

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.

Yes. Clinical trial at each site shall be initiated after the approval of the clinical trial protocol and other related documents by the Ethics Committee for that site, registered with the CLA.

Yes. Before enrolment of first participant in any clinical trial, registration in CTRI is mandatory.

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.

Yes. Before enrolment of first participant in any clinical trial, registration in CTRI is mandatory

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.

If a clinical trial site does not have its own ethics committee, clinical trial at that site may be initiated after obtaining approval of the protocol from the ethics committee of another trial site. Provided that the approving ethics committee for clinical trial shall be responsible for the study at the trial site and the same shall be located within the same city or within a radius of 50 kms of the actual clinical trial site.

A “clinical investigation plan” is a document that describes the reasons, objectives, design methodology, monitoring, and statistical considerations. It also includes the proposed analysis, monitoring, conduct, and record-keeping for the clinical investigation.

Pilot studies for drug or device development are typically performed as a priori at the beginning of the process. They can be conducted when little or no clinical experience is available with the device or drug. Pilot studies refer to clinical trials that gather specific essential information about a device or drug before starting the pivotal trial. These trials will be used to make precise claims about safety and efficacy. A pivotal study is a clinical test that attempts to show the efficacy of a new drug, and it can be used to gain marketing approval from the regulatory authority. A pivotal clinical study aims to demonstrate that a novel experimental drug is more efficient than an existing standard-of-care drug.

Minimum of seven members from medical, non-medical, scientific and non-scientific areas with at least, one lay person; one woman member; one legal expert; one independent member from any other related field such as social scientist or representative of non-governmental voluntary agency or philosopher or ethicist or theologian. At least 50% of members not affiliated with the institute or organization in which EC is constituted. Every member of the EC shall be required to undergo such training and development programs.

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