Regulatory Focus™ > News Articles > CDSCO Advances Draft Medical Device Rules, Outlines Fees

CDSCO Advances Draft Medical Device Rules, Outlines Fees

Posted 26 September 2016 | By Michael Mezher 

CDSCO Advances Draft Medical Device Rules, Outlines Fees

India's Central Drugs Standard Control Organization (CDSCO) on Monday released an updated version of its draft rules for medical devices, including fees payable by industry, after consultations with stakeholders.

In June, India announced it was abandoning its plan to amend the Drugs and Cosmetics Act of 1940 in favor of developing new, separate legislation for the regulation of drugs and medical devices.

Shortly afterwards, CDSCO released preliminary draft rules establishing a class-based risk system for medical devices ranging from Class A (low risk) to Class D (high risk), with Class B and C occupying the middle ground (low moderate risk and high moderate risk).

However, CDSCO had not initially elaborated on the amounts the various fees that would be applicable to industry.

Now, in the newly released draft rules, CDSCO has included a fee table covering fees related to medical devices.

Notably, the agency still has not divulged the fee amounts that notified bodies can charge for their services; which, under the draft rules, are to be set by the central government.

Fees Under Draft Medical Device Rule, 2016
SectionFeeAmount (in Indian Rupees (₹) unless marked in US Dollars ($))
12(2)Registration of notified body₹50,000
15(4)Manufacturing license of Class A medical device for one site₹5,000
15(5)Manufacturing license of Class B medical device for one site₹5,000
15(5)Manufacturing license of Class C or Class D medical device₹50,000 for one site; ₹1,000 for each distinct device
15(5)Manufacturing license of Class C or Class D along with Class A or Class B medical device₹50,000 for one site; ₹1,000 for each distinct Class C or Class D device; ₹200 for each distinct Class A or Class B device
16(1)Loan license to manufacture of Class A or Class B medical device for one site
₹5,000
16(2)Loan license to manufacture of Class C or Class D medical devices₹50,000 for one site; ₹1,000 for each distinct device
24(1)Manufacturing license or loan license retention fee of Class A or Class B or Class C or Class D₹50,000
27(1)Test license to manufacture for clinical investigations, test, evaluation, examination, demonstrating or training₹500
30(3)Import license for Class A medical device$1,000 for one site; $50 for each distinct device
30(3)Import license for Class B medical device$1,000 for one site; $50 for each distinct device
30(3)Import license for Class C and Class D medical device$3,000 for one site; $1,500 for each distinct medical device
30(7)License is defaced, damaged or lost$300
31Inspection of the overseas manufacturing site$6,000
33(1)Import license retention fee of Class A or Class B or Class C or Class D$3,000
36(3)Import license for test, evaluation or demonstration or training₹500 for each distinct device
37(1)Import of investigational medical device by Government hospital or statutory medical institution for treatment of patient₹500 for each distinct device
45(2)(a)Permission to conduct pilot clinical investigation₹100,000
45(2)(b)Permission to conduct pivotal clinical investigation₹100,000
52(2)Permission to conduct clinical performance evaluation₹25,000
57(1)Permission to import or manufacture an investigational medical device₹50,000
58(1)Permission to import or manufacture new in vitro diagnostic medical device₹25,000

Draft Medical Device Rules, 2016


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