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 devices already in distribution while submitting and completing the licensing process. To benefit from transitional supply, evidence that the device was on the market before the notification date must be maintained. Manufacturers who fail to submit a licence application by the deadline lose the right to supply, even during the transition period.
Always check the CDSCO website and the Official Gazette for the most current schedule of notified devices and any active transition periods.
The 2020 expansion (1 April 2020) brought 21 categories into scope, including orthopaedic implants (knees, hips, spine), cardiac stents, and cardiac pacemakers. Manufacturers should cross-reference the Official Gazette notification G.S.R. 262(E) dated 1 April 2020 for the complete list of notified categories effective from that date.
After expiration of a transition period, devices that are subject to the new notification may no longer be imported or supplied unless a valid licence (Form MD-14) or registration (Form MD-15) has been obtained. Continuation of supply without a valid licence after the transition period ends constitutes a violation of MDR 2017 and may result in product seizure and regulatory action.