| 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 |