Essential principles checklist: (i) The dossier should contain the following:— (a) the essential principles; (b) whether each essential principle applies to the device and if not, why not; (c) the method used to demonstrate conformity with each essential principle that applies; (d) a reference for the method employed (e.g., standard); and (e) the precise identity of the controlled document that offers evidence of conformity with each method used. (ii) Methods used to demonstrate conformity may include one or more of the following:— (a) conformity with standards as referred to in rule 7; Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 109 of 248 (b) conformity with an in-house test method; (c) the evaluation of pre-clinical and clinical evidence; (d) comparison to a similar device already available on the market.