CDSCO Fees structure for medical devices

# Rule Subject Fee
0113(5)Registration of Notified Body.₹ 25000
0213(7)Registration retention fee of Notified Body.₹ 25000
0320(2)Manufacturing licence or loan licence to manufacture Class A or Class B medical device for
0320(2)(a) one site and₹ 5000
0320(2)(b) each distinct medical device.₹ 500
0421(2)Manufacturing licence or loan licence to manufacture Class C or Class D medical device for
0421(2)(a) one site and₹ 50000
0421(2)(b) each distinct medical device.₹ 1000
0529(1)Manufacturing licence or loan licence retention fee for
0529(1)(a) one site manufacturing Class A or Class B medical device or₹ 5000
0529(1)(b) one site of manufacturing Class C or Class D medical device or₹ 50000
0529(1)(c) each distinct medical device of Class A or Class B or₹ 500
0529(1)(d) each distinct medical device of Class C or Class D.₹ 1000
0631(1)Test licence to manufacture for clinical investigations, test, evaluation, examination, demonstration or training for each distinct medical device.₹ 500
0734(2)Import licence for Class A medical device other than in vitro diagnostic medical device for
0734(2)(a) one site and $ 1000
0734(2)(b) each distinct medical device.$ 50
0834(2)Import licence for Class B medical device other than in vitro diagnostic medical device for
0834(2)(a) one site and $ 2000
0834(2)(b) each distinct medical device.$ 1000
0934(2)Import licence for Class A or Class B in vitro diagnostic medical device for
0934(2)(a) one site and $ 1000
0934(2)(b) each distinct medical device.$ 10
1034(2)Import licence for Class A or Class B in vitro diagnostic medical device for
1034(2)(a) one site and $ 3000
1034(2)(b) each distinct medical device.$ 1500
1534(2)Import licence for Class C or Class D in vitro diagnostic medical device for
1534(2)(a) one site and $ 3000
1534(2)each distinct in vitro diagnostic medical device.$ 500
1635(2)Inspection of the overseas manufacturing site.$ 6000
1737Import licence retention fee for
1737(a) one overseas site manufacturing Class A medical device other than in vitro diagnostic medical device or$ 1000
1737(b) one overseas site manufacturing Class B medical device other than in vitro diagnostic medical device or$ 2000
1737(c) one overseas site manufacturing Class C or Class D medical device other than in vitro diagnostic medical device or$ 3000
1737(d) each distinct medical device of Class A other than in vitro diagnostic medical device or$ 50
1737(e) each distinct medical device of Class B other than in vitro diagnostic medical device or$ 1000
1737(f) each distinct medical device of Class C or Class D other than in vitro diagnostic medical device.$ 1500
1737(g) one overseas site manufacturing Class A or Class B in vitro diagnostic medical device$ 1000
1737(h) one overseas site manufacturing Class C or Class D medical device other than in vitro diagnostic medical device$ 3000
1737(i) each distinct in vitro diagnostic medical device of Class A or Class B in vitro diagnostic medical device$ 10
1737(j) each distinct in vitro diagnostic medical device of Class C or Class D in vitro diagnostic medical device$ 500
1840(2)Fee for Import licence for test, evaluation or demonstration or training for each distinct medical device.$ 100
1942(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
2051(2)(a)Permission to conduct pilot clinical investigation.₹ 100000
2151(2)(b)Permission to conduct pivotal clinical investigation.₹ 100000
2259(2)Permission to conduct clinical performance evaluation.₹ 25000
2363(1)Permission to import or manufacture a medical device which does not have its predicate device.₹ 50000
2464(1)Permission to import or manufacture new in vitro diagnostic medical device.₹ 25000
2581(1)Registration of medical device testing laboratory to carry out testing or evaluation of a medical device on behalf of manufacturer.₹ 20000
2684Registration retention fee for medical device testing laboratory₹ 20000
2791Certificate to export of each distinct medical device.₹ 1000