Responsibilities of Sponsor: (i) The sponsor is responsible for implementing and maintaining quality assurance system to ensure that the clinical investigation is designed, conducted, monitored, and that data is generated, documented, recorded and reported in compliance with clinical investigational plan and Good Clinical Practices (GCP) Guidelines issued by the Central Drugs Standards Control Organization, Directorate General of Health Services, Government of India and applicable rules. Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India. (ii) The sponsor is required to submit a status report on Clinical Investigation to the Central Licensing Authority, at the prescribed periodicity including safety summary and deviations. (iii) Report of any serious adverse event occurring during clinical investigation, after due analysis, shall be forwarded by the sponsor to the Chairman of the Ethics Committee, Central Licensing Authority, and the Head of institution where the clinical investigation has been conducted within 14 calendar days from knowledge of occurrence of the serious adverse event as prescribed in Table 7 of this Schedule. (iv) In case of injury or death occurring to the clinical investigation subject, the sponsor or his representative whosoever, had obtained permission from the Central Licensing Authority for conduct of clinical investigation, shall make payment for medical management of the subject and also provide financial compensation for clinical investigation related injury or death in the manner as specified in the Drugs and Cosmetics Rules, 1945. (v) The sponsor or his representative, whosoever, had obtained permission from the Central Licensing Authority for conduct of clinical investigation shall submit details of compensation paid for clinical investigation related injury or death to the Central Licensing Authority within thirty days of the receipt of the order from Central Licensing Authority. (vi) The sponsor shall ensure that the clinical investigation report, whether for a completed or prematurely terminated clinical investigation, is provided to the Ethics Committee, participating investigators and to the Central Licensing Authority. (vii) In case, an investigation need to be discontinued prematurely for any reason including lack of commercial interest, the sponsor shall need to inform to the Central Licensing Authority and also submit summary report within a period of ninety days having a description of the investigation, the number of patients exposed to the investigational medical device, details of adverse device affect or serious adverse event, compensation paid, if any, and the reason for discontinuation of the investigation or non-pursuit of the investigational medical device application.