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. (f) Undertaking signed stating that the manufacturing site is in compliance with the provisions of the Fifth Schedule. (g) Documents as specified in the clause (b) of paragraph (i) of this Part. 43[(h) In case of in-vitro diagnostic medical devices, performance evaluation report by the manufacturer shall be submitted by the applicant: PROVIDED that when the State Licensing Authority specifically requires for Class B or the Central Licence Authority for Class B, Class C and Class D in-vitro diagnostic medical devices, as the case may be, applicant shall submit the report issued by the central medical devices testing laboratory or a medical device testing laboratory registered under rule 83 or by any laboratory accredited by the National Accreditation Board for Testing and Calibration Laboratories or by any hospital accredited by National Accreditation Board for Hospitals and Healthcare Providers or by any Central Government or State Government Laboratory of any hospital or of any institute, specified by the concerned State Licensing Authority or the Central Licensing Authority.]