CLINICAL INVESTIGATION (1) Approval for clinical investigation: (i) Clinical investigation on an investigational medical device shall be initiated only after approval has been obtained from the Ethics Committee(s), registered under rule 122DD of Drugs and Cosmetics Rules, 1945, and permission granted by Central Licensing Authority. The investigation shall be initiated at the respective sites only after obtaining such approval from the Ethics Committee for that site. Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India. (ii) All investigators should possess appropriate qualification, training and experience and should have access to such investigational and treatment facilities as are relevant to the proposed clinical investigation. A qualified physician (or dentist, when appropriate), who is an investigator or a sub-investigator for the investigation, shall be responsible for all investigation related decisions concerning medical or dental issues. Laboratories used for generating data for clinical investigation should be compliant with Good Laboratory Practices or should have accreditation certificate issued by National Accreditation Board for Testing and Calibration Laboratories. In all cases, information about laboratory or facility to be used for the investigation, if other than those at the investigation site, should be furnished to the Central Licensing Authority prior to initiation of investigation at such site. (iii) Clinical investigational plan amendments, if it becomes necessary, to so amend it, before initiation or during the course of a clinical investigation, shall be notified to the Central Licensing Authority in writing along with approval of the Ethics Committee, if available, which has granted the approval for the study. No deviations from or changes to clinical investigational plan shall be implemented without prior written approval of the Ethics Committee and the Central Licensing Authority except when it is necessary to eliminate immediate hazards to the study subject or when changes involve only logistic or administrative aspects of investigation. All such exceptions shall be immediately notified to the Ethics Committee as well as to the Central Licensing Authority within 30 days.