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