1.1 Introductory descriptive information on the in vitro diagnostic medical device, the intended use and risk class of in vitro diagnostic medical device, novel features (if any), claimed shelf life and a synopsis on the content of the dossier. 1.2 Regulatory status of the similar device in India (approved or new in vitro diagnostic medical device). 1.3 Domestic price of the in vitro diagnostic medical device in the currency followed in the country of origin. 1.4 Marketing history of the in vitro diagnostic medical device from the date of introducing the in vitro diagnostic medical device in the market. 1.5 List of regulatory approvals or marketing clearance obtained in below format (submit respective copy of approval certificate). SI. No. Name of the country Approved indication Approved shelf life Composition Risk Class Date of first approva