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Regulatory News | 26 September 2016 | By Michael Mezher
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.
Draft Medical Device Rules, 2016
Tags: Fees, Draft Medical Device Rules 2016