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

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.

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.

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.

Yes. The status of enrolment of the trial subjects shall be intimated to the CLA on quarterly basis or as appropriate as per the duration of treatment in accordance with the approved clinical trial protocol, whichever is earlier. Further, six monthly status report of each clinical trial, as to whether it is ongoing, completed or terminated, shall be submitted in SUGAM portal. In case of termination of any clinical trial the detailed reasons for such termination shall be communicated to CLA.

SUGAM portal is an e-Governance solution for CDSCO. SUGAM enables online submission of applications requesting for permissions related to drugs, clinical trials, ethics committee, medical devices, vaccines and cosmetics. SUGAM has facility for users to possess multiple roles on the same registered ID. Applicant can register with different purposes with the assigned roles and forms.