SECOND SCHEDULE [Refer rules 13(5), 13(7), 20(2), 21(2), 25(3), 29(1), 31(1), 34(2), 34(4), 35(2), 37, 40(2), 42(1), 51(2), 59(2), 63(1), 64(1), 81(1), 84, 27[87A(3), 87C(1) and] 91] FEE PAYABLE FOR LICENCE, PERMISSION AND REGISTRATION CERTIFICATE Sr. No. Ride Subject In rupees (INR) except where specified in dollars ($) (1) (2) (3) (4) 1. 13(5) Registration of Notified Body 25000 2. 13(7) Registration retention fee of Notified Body 25000 3. 20(2) Manufacturing licence or loan licence to manufacture 28[Class A (other than non-sterile and non-measuring)] or Class B medical device for, — — 4. (a) one site; and 5000 5. (b) each distinct medical device 500 6. 21(2) Manufacturing licence or loan licence to manufacture Class C or Class D medical device for, — — 7. (a) one site; and 50000 8. (b) each distinct medical device 1000 Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 91 of 248 9. 29(1) Manufacturing licence or loan licence retention fee for, — — 10. (a) one site manufacturing 29 [Class A (other than non-sterile and non-measuring)] or Class B medical device; or 5000 11. (b) one site of manufacturing Class C or Class D medical device; or 50000 12. (c) each distinct medical device of 30[Class A (other than nonsterile and non-measuring)] or Class B; or 500 13. (d) each distinct medical device of Class C or Class D 1000 14. 31(1) Test licence to manufacture for clinical investigations, test, evaluation, examination, demonstration or training for each distinct medical device 500 15. 34(2) Import licence for 31[Class A (other than non-sterile and nonmeasuring)] medical device other than in vitro diagnostic medical device for, — 16. (a) one site; and $1000 17. (b) each distinct medical device $50 18. 34(2) Import licence for Class B medical device other than in vitro diagnostic medical device for, — 19. (a) one site; and $2000 20. (b) each distinct medical device $1000 21. 34(2) Import licence for 32[Class A (other than non-sterile and nonmeasuring)] or Class B in vitro diagnostic medical device for, — 22. (a) one site; and $1000 23. (b) each distinct in vitro diagnostic medical device $10 24. 34(2) Import licence for Class C or Class D medical device other than in vitro diagnostic medical device for, — — 25. (a) one site; and $3000 26. (b) each distinct medical device $1500 27. 34(2) Import licence for Class C or Class D in vitro diagnostic medical device for, — 28. (a) one site; and $3000 29. (b) each distinct in vitro diagnostic medical device $500 30. 35(2) Inspection of the overseas manufacturing site $6000 31. 37 Import licence retention fee for, — — 32. (a) one overseas site manufacturing 33[Class A (other than nonsterile and non-measuring)] medical device other than in vitro diagnostic medical device; or $1000 33. (b) one overseas site manufacturing Class B medical device $2000 Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 92 of 248 other than in vitro diagnostic medical device; or 34. (c) one overseas site manufacturing Class C or Class D medical device other than in vitro diagnostic medical device; or $3000 35. (d) each distinct medical device of 34[Class A (other than nonsterile and non-measuring)] other than in vitro diagnostic medical device; or $50 36. (e) each distinct medical device of Class B other than in vitro diagnostic medical device; or $1000 37. (f) each distinct medical device of Class C or Class D other than in vitro diagnostic medical device $1500 38. (g) one overseas site manufacturing 35[Class A (other than nonsterile and non-measuring)] or Class B in vitro diagnostic medical device; $1000 39. (h) one overseas site manufacturing Class C or Class D medical device other than in vitro diagnostic medical device; $3000 40. (i) each distinct in vitro diagnostic medical device of 36[Class A (other than non-sterile and non-measuring)] or Class B in vitro diagnostic medical device; $10 41. (j) each distinct in vitro diagnostic medical device of Class C or Class D in vitro diagnostic medical device; $500 42. 40(2) Fee for Import licence for test, evaluation or demonstration or training for each distinct medical device $100 43. 42(1) Fee for Import of investigational medical device by Government hospital or statutory medical institution for treatment of patient of each distinct medical device 500 44. 51(2)(a ) Permission to conduct pilot clinical investigation 100000 45. 51(2)(b ) Permission to conduct pivotal clinical investigation 100000 46. 59(2) Permission to conduct clinical performance evaluation 25000 47. 63(1) Permission to import or manufacture a medical device which does not have its predicate device 50000 48. 64(1) Permission to import or manufacture new in vitro diagnostic medical device 25000 49. 81(1) Registration of medical device testing laboratory to carry out testing or evaluation of a medical device on behalf of manufacturer 20000 50. 84 Registration retention fee for medical device testing laboratory 20000 51. 91 Certificate to export of each distinct medical device 1000 Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 93 of 248 37[52. 87A(3) Registration certificate for sale of medical devices 3000 53. 87C(1) Retention fee for registration certificate for sale of medical devices 3000