Regulatory changes, company milestones and policy updates affecting Indian medical device manufacturers. Curated from public sources — verify specifics with the original source before acting.
Draft notification G.S.R. 515(E) would cut approval timelines for Class B, C and D device manufacturing licences, splitting scrutiny and QMS audit into clearer steps. Public comments open until 22 July 2026.
MD Himanshu Baid says ₹250 Cr earmarked for technology-focused acquisitions, plus expansion into interventional cardiology, structural heart and renal diagnostics — targeting 12-13% of India's renal market this year.
New training centre strengthens Meril's presence in Eastern India, part of its 12-academy global education network for healthcare professionals.
Devices within the notified BIS scope face a hard compliance deadline — manufacturers who miss it risk losing market access. Applies alongside existing CDSCO licensing requirements.
New voluntary facility lets manufacturers confirm a device's risk class (A/B/C/D) before committing to a full licence application — aimed at reducing classification disputes and delays.
The ₹3,420 crore Production Linked Incentive scheme for medical devices wraps its 5-year window this fiscal year. Focus now shifts to post-PLI cost sustainability for beneficiary manufacturers including Skanray and Poly Medicure.