Design and manufacturing information: 4.1 Device Design: The dossier should contain information to allow the reviewer to obtain a general understanding of the design stages applied to the device. The information may take in form of flow chart. Device design validation data should be submitted. 4.2 Manufacturing Processes: The dossier should contain information to allow the reviewer to obtain a general understanding of the manufacturing processes. The information may take the form of flow chart showing an overview of production, manufacturing environment, facilities and controls used for manufacturing, assembly, any final product testing, labelling and packaging and storage of the finished medical device. If the manufacturing process is carried out at multiple sites, the manufacturing activities at each site should be clearly specified. 5.0 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. (iii) The essential principles checklist should incorporate a cross-reference to the location of such evidence both within the full technical documentation held by the manufacturer and within the dossier.