Discuss the role of cooperative federalism in regulating medical devices in India, with reference to the division of licensing authority between the Centre and States under MDR 2017.

Q. Discuss the role of cooperative federalism in regulating medical devices in India, with reference to the division of licensing authority between the Centre and States under MDR 2017. (15 marks, 250-350 words)

Health being a Concurrent List subject, medical device regulation is necessarily a shared enterprise. The Medical Devices Rules (MDR), 2017, notified under the Drugs and Cosmetics Act, 1940, institutionalise this sharing through a risk-proportionate division of licensing authority between the Central and State Licensing Authorities [1].

Division of licensing authority - Devices are classified on the GHTF framework into Class A (low), B (low-moderate), C (moderate-high) and D (high risk) [1]. - Class A and B manufacturing is licensed by State Licensing Authorities, following a Quality Management System audit by an accredited Notified Body [1]. - Class C and D are licensed by the Central Licensing Authority (CDSCO), with expert or notified-body assistance where required [1]. - Uniform substantive standards — QMS aligned to ISO 13485 — apply irrespective of the licensing tier [1].

How this advances cooperative federalism - Subsidiarity: routine, low-risk approvals sit closest to the manufacturer, while technically demanding high-risk devices are centralised — matching capacity to complexity. - Common regulatory grammar: a single classification, a shared online portal, and licences valid without periodic renewal reduce inter-state divergence and forum-shopping [1]. - Joint capacity-building: CDSCO handheld States during the phased transition to licensing of Class A and B devices from October 2022, illustrating Centre-State handholding rather than command [3]. - Convergent reform agenda: the draft amendment notification of June 2026 proposes defined timelines for each licensing stage — scrutiny, notified-body audit, verification and grant — binding both Centre and States to a predictable clock [2].

Persisting frictions - Uneven State drug-control staffing and inspectorate capacity causes variable approval speeds. - Self-certification for Class A devices demands stronger post-market surveillance, largely a State function.

Cooperative federalism here is thus less about power-sharing than capability-sharing. Sustained investment in State regulatory capacity, coupled with the proposed time-bound framework, can align patient safety with the National Medical Devices Policy, 2023 goal of making India a trusted global manufacturing hub [4].

(~320 words)

Sources: 1. Health Ministry Notifies Medical Devices Rules, 2017 — PIB — GHTF-based Class A–D classification, State licensing of Class A/B after Notified Body QMS audit, Central licensing of Class C/D, ISO 13485 alignment, online portal 2. Union Ministry of Health and Family Welfare Proposes Amendments to Medical Devices Rules, 2017 to Streamline Licensing Process — PIB — June 2026 draft notification defining stage-wise licensing timelines 3. Health Regulator geared up for smooth transition to licensing of Class A and B Medical Devices w.e.f. 1st October 2022 — PIB — phased transition and Centre-State facilitation 4. Cabinet approves the Policy for the Medical Devices Sector — PIB — National Medical Devices Policy, 2023 and the global manufacturing hub objective