GOVERNMENT POLICIES, REFORMS & FUNDING INITIATIVES
Policy Summaries
- PLI Scheme for Medical Devices – Progress & FY 2026 Outlook (ongoing FY 2022-23 to FY 2026-27): With a total outlay of ₹3,420 crore, the scheme offers 5% incentives on incremental sales across four high-import segments – cancer care/radiotherapy, radiology & imaging, anaesthetics & cardio-respiratory devices, and implants. By September 2025, 22 greenfield medtech projects had been commissioned and production started for 55+ products including MRI scanners, CT scanners, LINACs, C-arm systems, mammography, and ultrasound equipment, generating cumulative eligible sales of ~₹12,344 crore including exports of ~₹5,869 crore.
- National Medical Devices Policy 2023 – Implementation Update (FY 2025-26): The policy guides medical device sector development across regulatory streamlining, infrastructure, R&D, innovation, and export positioning; implementation includes central schemes (PLI, device parks) and support for medical device parks in Uttar Pradesh, Madhya Pradesh, and Tamil Nadu. Medical device exports grew from US$2.9 billion in FY 2021-22 to US$4.1 billion in FY 2024-25, reflecting policy traction and creating a structured framework for domestic manufacturing and exports.
- CDSCO Medical Device Risk Reclassification & SaMD Guidance (2025-2026): CDSCO released a revised list of 553 cardiovascular and neurological devices re-classified by risk (Class A-D) aligned with IMDRF and MDR 2017, and published a 76-page draft guidance on Medical Device Software (SaMD/IVD software) covering scope, definitions, classification, QMS, and technical documentation. These updates tighten expectations on labelling, marketing claims, and technical documentation for all devices with software or AI components.
- Scheme for Strengthening of Medical Device Industry (SMDI) – ₹500 Crore (launched November 2024; proposals active): Total outlay of ₹500 crore over three years (FY 2024-25 to FY 2026-27) with sub-schemes for common testing facilities in device clusters, skill development, marginal-investment support, and promotional activities. DoP invited cluster proposals in January 2026 for common testing and evaluation facilities in device clusters – creating publicly supported testing labs that will procure advanced lab and testing equipment.
- India-US Medical Devices Trade Framework – US Tariff Cut from ~50% to ~18% (reported February 2026): Under a new bilateral understanding, the US cut import tariffs on Indian medical devices from approximately 50% to approximately 18%, providing Indian exporters with a significant cost advantage versus Chinese competitors. This is expected to unlock substantial MedTech export potential for Indian diagnostic and device manufacturers using SIDMA-supplied scientific and medical subsystems.
- India-EU Free Trade Agreement – Medical Device Tariff Provisions (crystallised February 2026): The FTA removes or sharply reduces tariffs on most EU-origin medical devices exported to India while also supporting regulatory cooperation and technology transfer opportunities. Short-term, EU devices gain price competitiveness in India; medium-term, this opens collaboration avenues for SIDMA to integrate EU technology into locally manufactured platforms.
- NCSTC 2026 – National Conference on Strategic Trade Controls (held 15 January 2026): DGFT in collaboration with MEA and FIEO covered SCOMET policy, licensing, enforcement, and compliance for dual-use technology exporters; focused specifically on quantum, advanced computing, semiconductors, additive manufacturing, and cyber-security – and their export-control implications. The third edition of the Handbook on India’s Strategic Trade Control System was released.
Actionable Policy Table
| Policy / Reform | What It Does | Why It Matters in the Next 60 Days | Key Action for SIDMA Members |
| PLI Medical Devices – Final Year (FY 2026-27); 22 projects operational | 5% incentive on incremental sales; 55+ device categories in production; ₹12,344 crore eligible sales so far | PLI-funded MRI, CT, LINAC, mammography, ultrasound facilities are in active production ramp-up and need calibration, QA, and validation instruments now – this window closes when PLI ends | Identify and visit PLI-commissioned manufacturers from DoP’s project list; pitch calibration, QA instrument, and validation equipment packages before their first full-year production audit (typically April-June) |
| SMDI Scheme – ₹500 Crore (cluster lab funding; proposals under review) | Common testing lab infrastructure in device clusters; January 2026 proposals under review by DoP | Approved clusters will begin procuring shared testing and validation equipment in Q2-Q3 2026 | Contact cluster management at Greater Noida (UP), Kanchipuram (TN), and Ujjain (MP) device parks; register as preferred vendor for lab instruments and testing equipment in common facility procurement |
| India-EU FTA – EU devices get zero/near-zero tariffs into India | EU-origin medical devices face reduced or zero tariffs; regulatory cooperation framework active | EU devices become more price-competitive in India immediately; Indian manufacturers need a response strategy | For importers: adjust pricing models to reflect reduced duty on EU devices. For manufacturers: engage EU OEMs about technology licensing, co-manufacturing, or OEM supply agreements under the regulatory cooperation framework |
| CDSCO Procurement Licensing Circular (Nov 2025) | Procurement agencies must verify supplier CDSCO/state licence validity | Government tenders in Q2 2026 (April-June) enforce this; non-compliant suppliers lose eligibility | Verify all CDSCO manufacturing and import licences are valid and up-to-date; prepare current certificate copies for rapid attachment to tender responses |
| BIS 214 Device Standards Programme | Standards for 214 critical devices; 16 new standards effective April 2025; BIS standards now checked in CDSCO evaluations and government tenders | Q2 2026 tenders are requiring BIS compliance certificates – non-compliant products lose tendering eligibility | Audit all product lines against current BIS standards; obtain conformance test reports from NABL-accredited labs for any product entering a government tender in the next 60 days |
| RDI Fund – ₹1 Lakh Crore (₹4,000 crore initial disbursements via TDB and BIRAC) | Long-tenure low-interest R&D financing; targets biotech, pharma, AI, deep tech | First funded organisations are now moving to equipment acquisition phase following early-2026 disbursements | Register vendor interest at rdifund.anrf.gov.in; contact TDB and BIRAC for list of funded projects; position advanced analytical, lab automation, and testing instruments early with newly funded entities |
Disclaimer: Policy details are current as of 13 April 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).