Policy Summaries

• Draft Medical Devices (Amendment) Rules 2026 – G.S.R. 270(E) (draft notified 10 April 2026): This draft amends the Medical Devices Rules 2017, refining licensing, perpetual validity and testing-fee structures particularly in the Ninth Schedule. It builds on earlier 2025 draft amendments that clarified labelling, registration numbers, testing-lab obligations (Form MD-44) and made device licences and registrations perpetually valid subject to retention fees – reducing administrative burden on manufacturers and importers while raising expectations for post-market surveillance and quality documentation.
• PLI Scheme for Medical Devices – 2025 Progress Update (ongoing FY 2020-21 to FY 2027-28): By late 2025, 21 projects have begun manufacturing 36-54 high-end medical devices under the PLI scheme – spanning imaging, diagnostics, critical care, renal, orthopaedic implants and oncology equipment – often at prices 10-30% below imported equivalents. Dedicated medical device parks in Uttar Pradesh, Madhya Pradesh and Tamil Nadu with shared testing and sterilisation infrastructure (EMC, biocompatibility, gamma-radiation facilities) are reducing capex for new manufacturers and clustering SIDMA-addressable customers in defined geographies.
• National Conference on Strategic Trade Controls (NCSTC) 2026 – New Delhi (held 15 January 2026): DGFT, MEA and FIEO convened NCSTC 2026 at Bharat Mandapam with thematic sessions on SCOMET policy, licensing, enforcement, electronics/IT, biotech, chemicals, aerospace and emerging technologies (semiconductors, quantum, additive manufacturing). DGFT and MEA officials presented India’s strategic-trade control system, SCOMET policy, licensing processes, enforcement mechanisms and guidance on intangible technology transfers (ITT) – the session outputs shape export-licensing practices and compliance expectations for SIDMA members exporting sensitive instruments.
• Annual Medical Device Regulatory & Quality Summit 2026 (10th Edition – upcoming August 2026): This summit series reviews MDR 2017 amendments, classification guidelines, testing-lab requirements, labelling and post-market surveillance, alongside quality-system expectations and global regulatory alignment. Sessions focus on CDSCO approvals, import and manufacturing licensing, and practical compliance implementation for Indian device companies – useful for SIDMA members anticipating regulatory shifts that affect documentation, testing and distribution obligations.
• India Health Exhibition 2026 – Conference Agenda (21-23 August 2026): The conference track alongside India Health 2026 includes sessions on digital health, hospital infrastructure, regulatory frameworks, quality standards and investment, with Indian and international speakers. While not a policy-issuing body, it acts as a key implementation and interpretation forum for health-sector reforms affecting equipment procurement and deployment.

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Standards & Regulatory Framework

• Medical Devices Rules 2017 (MDR) – Ongoing Updates and Guidance (2017-2026): MDR 2017 provides a risk-based classification system (Class A-D) and detailed approval pathways for device manufacturing, import, testing, clinical investigation and performance evaluation. CDSCO has issued guidance documents on grouping, essential performance principles, free-sale certificates, checklists for import forms (MD-14/15), and mandatory registration of medical device testing laboratories (MD-39/40), while 2025-26 draft amendments add new forms (MD-44) and reinforce quality-system obligations for distributors and importers.

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Actionable Policy Table

Policy / Reform	What It Does	Why It Matters in the Next 60 Days	Key Action for SIDMA Members
Draft MDR Amendment G.S.R. 270(E) – Perpetual Licences + Testing-Lab Obligations (draft 10 Apr 2026)	Makes device manufacturing/import licences perpetually valid subject to retention fees; adds new Form MD-44 testing-lab reporting; clarifies Ninth Schedule fee structures	Final notification expected soon; perpetual validity changes long-term compliance cost planning and renewal calendars for all imported devices	Monitor MoHFW Gazette for finalization; update licence-renewal calendars to account for perpetual validity; prepare Form MD-44 compliant test & evaluation documentation frameworks for product lines now
GFR Amendment – Non-GeM Procurement Allowed; GTE up to ₹200 crore; Direct Purchase to ₹2 lakh	Doubles direct-purchase limits; removes GeM-only constraint for quality-critical research equipment; raises committee and tender thresholds	Active procurement cycle at CSIR, ICMR, IITs, ICAR, DRDO – faster and higher-value purchasing is now possible without cumbersome tendering	Deliver GFR-compliant direct-purchase catalogues to DST, ICMR, ICAR, DRDO, DBT purchase officers by end of May 2026; flag items under ₹2 lakh explicitly; emphasise technical superiority over GeM alternatives where catalogue quality is inadequate
PLI Medical Devices – Final Year (FY 2027-28 extended); 21 projects; 36-54 devices in production	Financial incentives for greenfield medical device manufacturing; device parks with shared testing infrastructure in UP, MP, TN	PLI-funded imaging and diagnostic device manufacturers are in active production ramp-up and need calibration, QA and validation instruments; device parks are procuring shared testing equipment now	Contact PLI-commissioned manufacturers using DoP’s project list; pitch calibration, QA instrument and validation equipment packages; approach park management at YEIDA (UP), Kanchipuram (TN), Ujjain (MP) for preferred vendor listings
SCOMET – NCSTC 2026 Outcomes & Dual-Use Equipment Controls (updated October 2025)	India’s SCOMET regime covers advanced lab instruments, nuclear-related measuring devices and dual-use electronics; Category 7 for quantum, semiconductors, cryogenic added October 2025	Any export since October 2025 of potentially controlled high-end scientific equipment without DGFT licence is a live compliance exposure	Audit all export shipments since October 2025 at www.dgft.gov.in; obtain retroactive and prospective licences; download the Third Edition Handbook on India’s Strategic Trade Control System from NCSTC 2026 and train sales/logistics teams
GeM Reforms – Technical Suitability Over L1; Non-GeM Allowed for Specialist Items	R&D institutes can bypass GeM for quality-critical specialist equipment; technical suitability now explicitly recognised	Allows SIDMA members to compete for research-institution contracts on quality, not just price; removes the L1-via-GeM barrier for specialised instruments	Train sales teams to present technical differentiation arguments when engaging GeM-alternative procurement at research institutions; prepare technical evaluation documentation to support quality-based procurement decisions

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Disclaimer: Policy details are current as of 17 May 2026. Cross-reference with: DGFT (www.dgft.gov.in) | CDSCO (www.cdscomdonline.gov.in) | DST/RDI (www.rdifund.anrf.gov.in) | BIS (www.bis.gov.in) | DoP (www.pharmaceuticals.gov.in) | PHARMEXCIL (www.pharmexcil.com).