(ii) Documents to be submitted with the application for grant of licence to manufacture or import Class B, Class C or Class D medical device The domestic manufacturer or authorised agent shall submit the duly signed following information pertaining to manufacturing site:— Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 100 of 248 (a) Constitution details of domestic manufacturer or authorised agent. (b) Site or plant master file as specified in Appendix I of this Schedule. (c) Device master file as specified in Appendix II for medical devices other than in vitro diagnostic medical devices, or Appendix III for in vitro diagnostic medical devices of this Schedule. (d) Essential Principles checklist for demonstrating conformity to the Essential Principles of Safety and Performance of the Medical Device including in vitro diagnostic medical device. (e) Test licence obtained for testing and generation of quality control data (for domestic manufacturers only), if any.