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 of India Page 105 of 248 Status of market clearance pending, rejected or withdrawn Regulatory Agency of the country Indication for use Registration status and date Reason for rejection/ withdrawal, if any 1.10 Safety and performance related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: (a) Summary of reportable event and field safety corrective action from the date of introduction:— For Serious Adverse Event: SI. No. Serious Adverse Event (SAE) Duration Number of the SAE reported Total Units sold Lot/Batch From To No.