The information required under sub-rule (2) shall contain the following, namely:— (i) approval from an Ethics Committee, which is registered with the Central Licensing Authority, as specified in Appendix VIII of the Schedule Y of the Drugs and Cosmetics Rules, 1945 and referred to in the Seventh Schedule; (ii) source and quantity of samples which shall be used during evaluation; (iii) device description including specification of raw material and finished product, data allowing identification of the device in question, proposed instruction for use 23[or electronic instructions for use], labels and regulatory status in other countries, if any; (iv) in house performance evaluation data used to establish stability, specificity, sensitivity, repeatability and reproducibility; (v) clinical performance evaluation plan stating in particular the purpose, scientific, technical or medical grounds and scope of evaluation; (vi) Case Report Form as specified in Table 6 of the Seventh Schedule; (vii) undertaking by investigators as specified in Table 9 of the Seventh Schedule; (viii) the list of laboratories or other institutions taking part in the evaluation study; (ix) the scheduled duration for evaluation and, in case of devices for selftesting, the location and number of lay persons involved; (x) an undertaking that the device in question conforms to the requirements of these rules, apart from aspects covered by evaluation and apart from those specifically itemised in the undertaking, and that every precaution has been taken to protect the health and safety of the patient, user and other persons.; Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 54 of 248 (xi) Performance evaluation report from a laboratory designated under subrule (1) of rule 19.