PART II (i) Documents to be submitted with the application for grant of Import Licence or licence to manufacture for sale or for distribution of a Class A 40[(other than non-sterile and non-measuring)] medical device (a) The applicant shall submit documents as specified in the Table below:— S.No. For medical devices other than in vitro diagnostic medical device For in vitro diagnostic medical device 1. device description, intended use of the device, specification including variants and accessories; device description, intended use of the device, specification including variants and accessories; 2. material of construction; a summary of analytical technology, relevant analytes and test procedure; 3. working principle and use of a novel technology (if any); working principle and use of a novel technology (if any); 4. labels, package inserts (41[instructions for use or electronic instructions for use], etc.), user manual, wherever applicable; Labels and package inserts ( 42[instructions for use or electronic instructions for use], etc.) , user manual, wherever applicable; 5. summary of any reported Serious Adverse Event in India or in any of the countries where device is marketed and action taken by the manufacturer and National Regulatory Authority concerned; analytical performance summary including sensitivity and specificity; 6. site or plant master file as specified in Appendix I of this Schedule; site or plant master file as specified in Appendix I of this Schedule; Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 99 of 248 7. constitution details of the firm (of domestic manufacturer or authorised agent); constitution details of the firm (of domestic manufacturer or authorised agent); 8. essential principles checklist for demonstrating conformity to the essential principles of safety and performance of the medical device; essential principles checklist for demonstrating conformity to the essential principles of safety and performance of the in vitro medical device; 9. undertaking signed by the manufacturer stating that the manufacturing site is in compliance with the provisions of the Fifth Schedule; undertaking signed by the manufacturer stating that the manufacturing site is in compliance with the provisions of the Fifth Schedule.