01 | 13(5) | Registration of Notified Body. | ₹ 25000 |
02 | 13(7) | Registration retention fee of Notified Body. | ₹ 25000 |
03 | 20(2) | Manufacturing licence or loan licence to manufacture Class A or Class B medical device for | |
03 | 20(2) | (a) one site and | ₹ 5000 |
03 | 20(2) | (b) each distinct medical device. | ₹ 500 |
04 | 21(2) | Manufacturing licence or loan licence to manufacture Class C or Class D medical device for | |
04 | 21(2) | (a) one site and | ₹ 50000 |
04 | 21(2) | (b) each distinct medical device. | ₹ 1000 |
05 | 29(1) | Manufacturing licence or loan licence retention fee for | |
05 | 29(1) | (a) one site manufacturing Class A or Class B medical device or | ₹ 5000 |
05 | 29(1) | (b) one site of manufacturing Class C or Class D medical device or | ₹ 50000 |
05 | 29(1) | (c) each distinct medical device of Class A or Class B or | ₹ 500 |
05 | 29(1) | (d) each distinct medical device of Class C or Class D. | ₹ 1000 |
06 | 31(1) | Test licence to manufacture for clinical investigations, test, evaluation, examination, demonstration or training for each distinct medical device. | ₹ 500 |
07 | 34(2) | Import licence for Class A medical device other than in vitro diagnostic medical device for | |
07 | 34(2) | (a) one site and | $ 1000 |
07 | 34(2) | (b) each distinct medical device. | $ 50 |
08 | 34(2) | Import licence for Class B medical device other than in vitro diagnostic medical device for | |
08 | 34(2) | (a) one site and | $ 2000 |
08 | 34(2) | (b) each distinct medical device. | $ 1000 |
09 | 34(2) | Import licence for Class A or Class B in vitro diagnostic medical device for | |
09 | 34(2) | (a) one site and | $ 1000 |
09 | 34(2) | (b) each distinct medical device. | $ 10 |
10 | 34(2) | Import licence for Class A or Class B in vitro diagnostic medical device for | |
10 | 34(2) | (a) one site and | $ 3000 |
10 | 34(2) | (b) each distinct medical device. | $ 1500 |
15 | 34(2) | Import licence for Class C or Class D in vitro diagnostic medical device for | |
15 | 34(2) | (a) one site and | $ 3000 |
15 | 34(2) | each distinct in vitro diagnostic medical device. | $ 500 |
16 | 35(2) | Inspection of the overseas manufacturing site. | $ 6000 |
17 | 37 | Import licence retention fee for | |
17 | 37 | (a) one overseas site manufacturing Class A medical device other than in vitro diagnostic medical device or | $ 1000 |
17 | 37 | (b) one overseas site manufacturing Class B medical device other than in vitro diagnostic medical device or | $ 2000 |
17 | 37 | (c) one overseas site manufacturing Class C or Class D medical device other than in vitro diagnostic medical device or | $ 3000 |
17 | 37 | (d) each distinct medical device of Class A other than in vitro diagnostic medical device or | $ 50 |
17 | 37 | (e) each distinct medical device of Class B other than in vitro diagnostic medical device or | $ 1000 |
17 | 37 | (f) each distinct medical device of Class C or Class D other than in vitro diagnostic medical device. | $ 1500 |
17 | 37 | (g) one overseas site manufacturing Class A or Class B in vitro diagnostic medical device | $ 1000 |
17 | 37 | (h) one overseas site manufacturing Class C or Class D medical device other than in vitro diagnostic medical device | $ 3000 |
17 | 37 | (i) each distinct in vitro diagnostic medical device of Class A or Class B in vitro diagnostic medical device | $ 10 |
17 | 37 | (j) each distinct in vitro diagnostic medical device of Class C or Class D in vitro diagnostic medical device | $ 500 |
18 | 40(2) | Fee for Import licence for test, evaluation or demonstration or training for each distinct medical device. | $ 100 |
19 | 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 |
20 | 51(2)(a) | Permission to conduct pilot clinical investigation. | ₹ 100000 |
21 | 51(2)(b) | Permission to conduct pivotal clinical investigation. | ₹ 100000 |
22 | 59(2) | Permission to conduct clinical performance evaluation. | ₹ 25000 |
23 | 63(1) | Permission to import or manufacture a medical device which does not have its predicate device. | ₹ 50000 |
24 | 64(1) | Permission to import or manufacture new in vitro diagnostic medical device. | ₹ 25000 |
25 | 81(1) | Registration of medical device testing laboratory to carry out testing or evaluation of a medical device on behalf of manufacturer. | ₹ 20000 |
26 | 84 | Registration retention fee for medical device testing laboratory | ₹ 20000 |
27 | 91 | Certificate to export of each distinct medical device. | ₹ 1000 |