Appendix II DEVICE MASTER FILE FOR MEDICAL DEVICES OTHER THAN IN VITRO DIAGNOSTIC MEDICAL DEVICES 1.0 Executive Summary: An executive summary shall be provided by the manufacturer and shall contain: 1.1 Introductory descriptive information on the medical device, the intended use and indication for use, class of device, novel features of the device (if any), shelf life of the device and a synopsis on the content of the dossier. Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 104 of 248 1.2 Information regarding sterilization of the device (whether it is sterile or non-sterile; if sterile, mode of sterilization). 1.3 Risk Management Plan, Risk Analysis, evaluation and control documents. 1.4 Clinical Evidence and evaluation (if applicable). 1.5 Regulatory status of the similar device in India (approved or not approved in India). 1.6 Design Examination Certificate, Declaration of Conformity, Mark of Conformity Certificate, Design Certificate (if applicable). Copy of such certificate(s) shall be enclosed. 1.7 Marketing history of the device from the date of introducing the device in the market. 1.8 Domestic price of the device in the currency followed in the country of origin. 1.9 List of regulatory approvals or marketing clearance obtained (submit respective copies of approval Certificates):— Country Approved Indication Approved Shelf life Class of Device Date of First Approval USA Australia Japan Canada European Union Others* * Optional Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 105 of 248 Status of market clearance pending, rejected or withdrawn Regulatory Agency of the country Indication for use Registration status and date Reason for rejection/ withdrawal, if any 1.10 Safety and performance related information on the device: