Examine the federal structure of medical device licensing in India, distinguishing the roles of State and Central Licensing Authorities.

Medical devices in India are regulated as "drugs" under the Drugs and Cosmetics Act, 1940, operationalised through the Medical Devices Rules, 2017 (effective 1 January 2018) [2]. Since drugs fall in the Concurrent List, licensing is deliberately split between Central and State authorities on a risk-graded basis — a cooperative-federal design that matches regulatory capacity to device risk.

The risk-based logic underpinning the split

• Devices are classified into Class A (low), B (low-moderate), C (moderate-high) and D (high) risk, mirroring globally harmonised practice [1].
• Regulatory intensity rises with class: Class A non-sterile, non-measuring devices need only online registration, not a licence [1].
• Risk, not geography, is thus the primary allocator of jurisdiction.

Role of State Licensing Authorities

• Grant manufacturing licences for Class A and B devices, after a Quality Management System audit by an NABCB-accredited Notified Body [1].
• Class A licences are issued on self-certification, with post-approval audit by the Notified Body — a trust-based, decentralised model [1].
• Full rollout of Class A/B licensing took effect from 1 October 2022, completing phased implementation [4].

Role of the Central Licensing Authority (CDSCO)

• Licenses Class C and D devices — cardiac stents, hip and knee implants and other orthopaedic implants — where failure risks life [3].
• Handles imports, clinical investigations and national standards, ensuring uniformity across states.
• The draft amendment to the 2017 Rules proposes cutting the Class C/D licensing timeline from 105 to 90 days and fixing stage-wise timelines for scrutiny, audit and issuance [3].

Frictions

• Uneven State drug-control staffing and inconsistent enforcement dilute uniformity; Notified Body capacity remains thin [1].

The architecture sensibly reserves high-risk oversight for the Centre while decentralising routine licensing, but its credibility rests on State-level capacity. Strengthening State drug administrations, expanding accredited Notified Bodies and digitising approvals — alongside the Policy for the Medical Devices Sector [5] — can make this federal model both quick and safe, advancing ease of doing business without diluting patient protection.