For a new in vitro diagnostic medical device: Where relevant to demonstrating conformity to the essential principles, and to provide general background information, the device master file may provide a summary of Clinical Performance Evaluation reports. 2.3 For an in vitro diagnostic medical device already available on the market in India: Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India. (i) This information may include a summary of the number of adverse event reports rela ted to the safety and performance of this in vitro diagnostic medical device in relation to the number of in vitro diagnostic medical devices placed on the market. (ii) External certificates and documents which give written evidence of conformity with the essential principles may be annexed to the device master file. (iii) Comparative analysis to prove substantial equivalence to the predicate device(s), if claimed in the application. 3.0 Essential principles checklist: (i) The device master file should include an essential principles checklist that identifies: (a) the essential principles of safety and performance; (b) whether each essential principle applies to the in vitro diagnostic medical device and if not, why not; (c) the method used to demonstrate conformity with each essential principle that applies; and (d) the reference to the actual technical documentation that offers evidence of conformity with each method used. (ii) The method used to demonstrate conformity may include one or more of the following:— (a) conformity with recognized or other standards; (b) conformity with a commonly accepted industry test method (reference method); (c) conformity with appropriate in house test methods that have been validated and verified; (d) comparison to an in vitro diagnostic medical device already available on the market.Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India. (iii) The essential principles checklist should include a cross-reference to the location of such evidence both within the full technical documentation held by the manufacturer and within the Device master file (when such documentation is specifically required for inclusion in the Summary Technical Documentation as outlined in this guidance).