If the application is for conduct of clinical investigation as a part of multi-national clinical development of medical device, the number of sites and the patients as well as justification to conduct such clinical investigation in India shall be provided to the Central Licensing Authority. (7) Pivotal Clinical Investigation: (i) The pivotal clinical investigation is a definitive study in which evidence is gathered to support the safety and effectiveness evaluation of the medical device for its intended use. Pivotal clinical investigation is confirmatory study that may be conducted in large number of patients with disease or condition being studied and scope to provide the effectiveness and adverse effects. (ii) For investigational medical device which does not have a predicate medical device but has been approved for sale or distribution in any country other than India, pivotal studies need to be carried out primarily to generate evidence of safety and effectiveness of the medical device in Indian patients when used as recommended in the prescribing information except in cases of investigational medical device classified under class A which shall be governed as per permission of para 6 above. Prior to conduct of pivotal clinical investigation in Indian subjects, the Central Licensing Authority may require making the pilot study data available to assess whether the pilot data is in conformity to the data already generated outside the country. (iii) If the application is for conduct of clinical investigation as part of a Global Clinical Investigation of medical device, the number of sites and patients as well as justification for undertaking such clinical investigation in India shall be provided to the Central Licensing Authority.