Policy Summaries

• CDSCO Medical Device Regulations and Risk Classification Updates (MDR 2017, ongoing 2025-2026): CDSCO continues operationalising MDR 2017 via detailed guidance on risk-based classification (Classes A-D), registration, import and manufacturing licences, and testing-lab registration. In early 2026 it finalized risk classification for oncology devices; 2025-26 guidance updates address digital workflows, post-approval changes and safety/performance requirements.
• Parliamentary Committee Report – Promotion of Medical Device Industry (tabled early 2026): The Standing Committee on Chemicals and Fertilizers criticised slow progress on medical device parks and recommended reduced GST rates on domestically produced devices, customs-duty concessions on key inputs, and expanded Phased Manufacturing Programmes. The report also emphasised scaling domestic R&D and aligning regulatory capacity with the sector’s growth targets.
• PLI Scheme for Medical Devices (FY 2020-21 to FY 2026-27): Budgetary outlay of ₹3,420 crore; performance-linked incentives on incremental sales of domestically manufactured devices in radiotherapy, imaging, critical care and implants. Strong momentum in device exports and increased investment in MedTech manufacturing through 2025-26.
• PLI Scheme for Pharmaceuticals (FY 2022-23 to FY 2027-28): Financial outlay of ₹15,000 crore supporting complex generics, biopharmaceuticals and IVD devices; investments exceeding ₹33,500 crore by October 2024 across 45 companies, with ₹3,215 crore in incentive payouts made.
• National Policy on R&D and Innovation in Pharma-MedTech (broader PRIP context): Aims to shift India from cost-based to innovation-led pharma-MedTech, targeting high-value IP, complex biologics and advanced devices. Encourages industry-academia collaboration and supports projects from TRL 1-3 up to market-ready products.
• SCOMET List Revision 2025 – DGFT Notification 31/2025-26 (effective October 2025): DGFT significantly revised the SCOMET list, aligning with global export-control regimes; new controls particularly in Category 7 covering semiconductors, quantum and cryogenic technologies, effective 23 October 2025. Exporters of sensitive or dual-use items must review new classifications and licensing norms; SCOMET export authorisations doubled from approximately USD 1.4 billion in 2023 to USD 2.8 billion in 2024.
• BIS Notification – 10 New and Revised Indian Standards including Medical Devices (December 2025 / Gazette January 2026): Ten key standards notified 17 December 2025; effective from 15 December 2025; concurrent validity of old standards ended 15 June 2026. From 14 June 2026, only the revised standards apply to procurement and tenders.
• ICMED 13485 Certification Scheme: AIMED and QCI jointly operate India’s voluntary ISO 13485-aligned quality-management certification scheme for medical devices. Hospitals and government programmes increasingly view ICMED/ISO 13485 as baseline quality markers for procurement.
• GeM, Public Procurement and Make in India Rules for Medical Devices: Consolidated 2026 guidance summarises procurement channels including GeM tenders, CGHS/PM-JAY reimbursement, Make in India preference margins, CDSCO/BIS prerequisites and tender design best practices. Make in India preference margins can be decisive in tender outcomes.
• Strengthening Quality Management Systems under MDR 2017 (ongoing 2025-2026): ISO 13485-compliant QMS strongly emphasised for design, production, testing and complaint handling; misclassification and poor documentation are the leading causes of regulatory rejection and tender disqualification.
• State-Level Assistance to R&D Laboratories – Gujarat (SARDARDL, active 2026): Gujarat government scheme providing financial assistance to state-backed R&D institutions for equipment acquisition and lab infrastructure; eligible institutions are in active procurement cycles for lab instruments.
• National Conference on Strategic Trade Controls (NCSTC) 2026 – New Delhi (15 January 2026): Covered India’s SCOMET framework, export-licensing processes, compliance for dual-use items and alignment with global regimes; 550-600+ participants from government, industry and foreign delegations.
• Clin Lab India Conference 2026 (30 January 2026, Bharat Mandapam): High-level panel on PLI 2.0 for IVD and MedTech, CDSCO modernisation, manufacturing clusters and diagnostic supply chain policy; targeted IVD manufacturers, component suppliers and regulators.
• 10th Annual Medical Device Regulatory & Quality Summit 2026 – New Delhi: Reviews evolving Indian and global medical device regulations, tariff headwinds, MDR changes, EU sustainability trends and marketing-code initiatives such as UCMPMD. Exact 2026 dates to be confirmed at www.meddeviceregulatorysummit.com.
• Customs & Trade Compliance India Summit 2026 (11th Edition): Inventicon Business Intelligence event focused on customs, import/export compliance, STPI/SEZ rules, EXIM compliance and trade-facilitation topics. Relevant for SIDMA importers and exporters managing HS classification and valuation issues.
• 9th Annual Pharma Regulatory Summit 2026 (24 March 2026, Mumbai): Focused on CDSCO updates, global regulatory trends, quality, compliance, equipment validation, data integrity and GMP for equipment-intensive operations; useful reference for equipment suppliers on client regulatory expectations.
• DIA-KMTC MedTech Conference 2026 – Kerala: Single-track MedTech conference by DIA with Kerala Medical Technology Consortium, covering regulatory, clinical and quality aspects; particularly relevant for members working with Kerala-based hospitals and manufacturers.

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) – Certificate of Registration, Sterilisation Labelling, Testing Fees	Introduces Certificate of Registration; mandates sterilisation-site labelling; sets new testing-fee schedule	Consultation window closed; final gazette notification can arrive any day without further warning	Monitor MoHFW Gazette daily; update sterilisation-site labelling on all sterile device packaging; revise costing models for devices requiring government testing-lab evaluation
Draft MDR Amendment G.S.R. 269(E) – QMS in Testing Labs and EU Conformity Recognition	Embeds QMS into testing-lab rules; recognises EU conformity assessment for testing equivalence	Final notification imminent – EU-conformity recognition could immediately reduce testing costs	Identify EU conformity certificates in your portfolio that may substitute for certain Indian tests under the new recognition provisions; brief regulatory team
CDSCO Online Risk Classification Portal	Pre-filing risk-class confirmation before full licence application; free to use	Any new device introduction or borderline product can be de-risked now at zero cost	Use the portal to pre-confirm risk classes for all new product lines before investing in full technical files, import licences or stock
CDSCO MDR 2017 – Risk Classes A-D, Oncology Classification, Ongoing Guidance	Detailed licensing forms, QMS requirements and clinical evidence expectations by risk class; oncology devices classified in January 2026	Correct classification is a prerequisite for any government tender response – misclassification causes rejection	Audit device portfolio against current CDSCO classification notifications; confirm risk class and correct licence form before submitting any June-July tender responses
National Medical Devices Policy 2023 (₹50 billion target by 2030)	Sets long-term quality, innovation and export framework for the sector	Creates the policy environment where quality, traceability and export-readiness are procurement prerequisites	Align long-term product strategy with the policy’s quality and export-readiness requirements; ensure ICMED/ISO 13485 certifications are in place
Parliamentary Committee – GST and Duty Recommendations for Medical Devices	Recommends reduced GST on domestic devices and duty concessions on key inputs	If accepted (timeline TBD), pricing and sourcing strategies will shift; domestic OEMs will become more competitive	Track parliamentary announcements on GST/duty changes; prepare alternative sourcing scenarios for devices that may see duty reductions on key components
PLI Medical Devices (₹3,420 crore; radiotherapy, imaging, critical care, implants)	Production incentives for high-end imaging, diagnostics, critical care and oncology devices	PLI-commissioned manufacturers are in active ramp-up; they need calibration, QA and validation instruments	Contact PLI-commissioned manufacturers from DoP’s published project list; pitch calibration, QA instrument and validation equipment packages
Scheme for Strengthening Medical Device Industry (SSMDI; ₹500 crore, 5 sub-schemes)	Funds cluster facilities, testing centres, design centres and clinical investigations	SSMDI-funded cluster facilities generate sustained demand for test, calibration and process validation equipment	Contact SSMDI-funded cluster managers in UP, TN and MP device parks; position calibration, validation and QA instruments with park tenants
Medical Device Parks (199 land allotments; 34 units under construction)	Common testing, sterilisation, EMI and biocompatibility infrastructure in Greater Noida, Ujjain and Kanchipuram	Parks are now operational and generating dense local demand for lab and QA equipment	Engage park management offices and newly allotted manufacturers; position lab instruments, QA systems and calibration services
Bulk Drug Parks (AP, Gujarat, Himachal; ₹1,000 crore each)	Integrated pharma manufacturing ecosystems; common infrastructure for APIs and formulations	Bulk drug parks are commissioning manufacturing capacity that requires extensive lab and QC instrumentation	Identify bulk drug park tenants via Department of Pharmaceuticals announcements; pitch process control, analytical and QC equipment packages
GFR Amendment – Non-GeM procurement; direct purchase to ₹2 lakh; GTE to ₹200 crore	Removes GeM-only constraint for quality-critical research equipment; enhanced institutional procurement authority	Active procurement at CSIR, ICMR, IITs, ICAR, DRDO; GFR window is fully open and the fastest procurement channel available	Deliver GFR-compliant technical-superiority documentation to institutional buyers at Bharat Buildcon Delhi (18-21 Jun) and during any Delhi engagements this week; flag items under ₹2 lakh as direct-purchase eligible
RDI Fund – ₹1 Lakh Crore (up to 50% of project cost; TDB open call launched)	Long-tenure low-interest R&D financing for TRL-4+ projects	Funded organisations are in equipment acquisition phase; first disbursements are flowing	Register vendor interest at rdifund.anrf.gov.in; position advanced analytical, lab automation and testing instruments with funded entities before RFPs are issued
PRIP Scheme – ₹5,000 crore; up to ₹100 crore per project	R&D funding for novel medical devices and pharma innovations; applications closed November 2025	PRIP-funded projects at NIPERs are transitioning to prototyping – instrumentation procurement follows	Contact NIPER Ahmedabad research administration to identify funded device projects; position prototyping instruments and analytical tools
SCOMET List Revision – DGFT Notification 31/2025-26 (effective October 2025; Category 7 updates)	New controls on semiconductors, quantum and cryogenic technologies; updated licensing norms	Any export since October 2025 of newly controlled items without a licence is a live compliance gap	Screen all exports of high-end analytical, cryogenic, quantum and imaging equipment against the revised Category 7 controls at www.dgft.gov.in; obtain licences before next shipment
BIS December 2025 Standards – Concurrent validity ended 15 June 2026	10 new/revised Indian Standards; old versions became invalid as of 15 June 2026	The transition window has now closed – any product still referencing superseded standards is non-compliant immediately	Verify immediately which products reference the superseded BIS standards; update labelling, conformance documentation and NABL test reports; do not respond to any government tender with superseded standard references
ICMED 13485 Certification	India’s voluntary ISO 13485-aligned device quality certification; increasingly a procurement prerequisite	Hospital and government procurement increasingly specifying ICMED/ISO 13485 as a baseline quality marker	Initiate ICMED 13485 application through a QCI-accredited body if not already certified; include certification in all tender submissions and distributor agreements
GeM, Make in India Preference and Procurement Framework	Make in India preference margins, GeM catalogue compliance and CDSCO/BIS prerequisites for public procurement	Government hospitals placing new orders; Make in India margins can be decisive in competitive tenders	Map all products eligible for Make in India preference; ensure GeM listings are current, CDSCO/BIS-compliant and price-competitive; use GFR non-GeM provisions for specialty items
Customs & Trade Compliance Summit 2026 (11th Edition)	Covers HS classification, import/export compliance, STPI/SEZ rules and tariff changes	HS misclassification and valuation disputes can delay consignments and increase landed cost	Register for or access the summit’s materials to update internal HS classification guides; review customs valuation methodologies for scientific and medical equipment
Gujarat State R&D Assistance Scheme (SARDARDL, active 2026)	Financial assistance for Gujarat state-backed R&D institutions for equipment and lab infrastructure	Gujarat R&D labs under this scheme are in active procurement cycles	Identify eligible Gujarat institutions at myscheme.gov.in; contact their purchase officers with targeted lab instrument offerings

Disclaimer: Policy details are current as of 14 June 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) | myScheme (www.myscheme.gov.in).