CDSCO Advances Draft Medical Device Rules, Outlines Fees
Posted 26 September 2016 | By
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|
|Section||Fee||Amount (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|
|31||Inspection 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