Discuss the regulatory evolution of medical devices in India from being treated as 'drugs' to a risk-based classification system. How do the proposed 2025-26 amendments to the Medical Devices Rules, 2017 seek to balance ease of doing business with patient safety?

For decades India regulated medical devices as "drugs" under the Drugs and Cosmetics Act, 1940, notifying devices one by one — a pharmaceutical template ill-suited to instruments and implants. The Medical Devices Rules, 2017, effective 1 January 2018, replaced this with a risk-proportionate framework [1], which the 2025-26 draft amendments now seek to make time-bound [2].

From "drugs" to a risk-based regime

• Notification-based era: only listed devices were regulated as drugs; unlisted ones stayed outside licensing, creating regulatory gaps.
• MDR, 2017: introduced four classes — A (low), B (low-moderate), C (moderate-high), D (high) — with obligations scaled to risk [1][3].
• Federal division of licensing: State Licensing Authorities licence Class A and B after a Quality Management System audit by a Notified Body accredited by NABCB; the Central Licensing Authority (CDSCO) handles Class C and D such as cardiac stents and knee implants [3].
• Phased rollout: licensing extended to Class A and B devices from 1 October 2022, completing coverage of the sector [4].
• Policy backing: the Cabinet-approved Policy for the Medical Devices Sector linked regulatory streamlining to domestic manufacturing growth [5].

Balancing ease of doing business with patient safety

• Predictability: defined timelines for each stage — application scrutiny, notified-body audit, compliance verification and licence issuance — replace open-ended discretion [2].
• Speed: the licence timeline for high-risk Class C and D devices is proposed to fall from 105 days to 90 days [2].
• Safety preserved: compliance with quality, safety and performance requirements is retained; only procedural delay, not scrutiny, is compressed [2].
• Consultative rule-making: the draft is placed in the Official Gazette and on the CDSCO website for stakeholder comments [2], mirroring the 2025 NDCT Rules reforms [6].

Regulation has thus matured from borrowed pharmaceutical rules to a calibrated, risk-based system. If paired with strengthened CDSCO capacity and robust post-market surveillance, faster approvals can advance both Atmanirbhar manufacturing and the citizen's right to safe healthcare under Article 21.