Phased Implementation & Transition History
India's transition to the Medical Devices Rules 2017 was deliberately phased to allow industry to adapt.
Pre-2018: limited regulation
Before MDR 2017, only a small number of device categories (initially 15 categories notified in 2005, later expanded) were regulated under the old drugs licensing framework. Most medical devices were unregulated.
2018: MDR 2017 comes into force
The Medical Devices Rules 2017 came into force on 1 January 2018, replacing the earlier licensing provisions. The initial scope covered devices that had already been notified.
2020: first major expansion
From 1 April 2020, a further 21 device categories (including orthopaedic implants, CT scanners, MRI equipment, and cardiac stents) were brought under mandatory CDSCO licensing.
2021: Amendment Rules 2021
The Medical Devices (Amendment) Rules 2021 introduced UDI requirements, updated vigilance provisions, and clarified the SUGAM submission process.
2022 onwards: Schedule I & II expansion
CDSCO has progressively expanded Schedules I and II through gazette notifications to bring additional device categories within regulatory scope. Companies must monitor the Official Gazette for notifications affecting their product categories.
Transition timelines
Each expansion notification generally provides a transition period (typically 12–24 months) during which manufacturers can continue to supply while completing the licensing process. Devices on the market before a notification are generally eligible for transitional supply subject to licence application submission.
Always check the CDSCO website and the Official Gazette for the most current schedule of notified devices and any active transition periods.