GOVERNMENT POLICIES, REFORMS & FUNDING INITIATIVES
Policy Summaries
- Draft Medical Devices Rules Amendment 2026 – G.S.R. 270(E) (draft dated 10 April 2026): MoHFW/CDSCO has issued a draft amendment to the Medical Devices Rules 2017, formalising a “Certificate of Registration” concept, clarifying testing fee schedules, and tweaking definitions and procedural wording. These changes are intended to improve clarity, transparency and procedural consistency in India’s medical device regulatory framework, and will affect registration workflows, testing costs and labelling obligations for device manufacturers and importers.
- SCOMET List Updates – Notification No. 31/2025-26 (effective 23 October 2025): DGFT updated India’s SCOMET list to align with multilateral export control regimes and national security objectives, introducing new entries and restructured classifications for advanced semiconductors, quantum technologies, cryogenic systems, semiconductor fabrication/testing/diagnostic equipment, and related software. Exporters of advanced lab and scientific instruments, biotech equipment, high-end imaging, and dual-use technologies must screen product catalogues for compliance and obtain DGFT licences where required.
- PLI Scheme for Medical Devices – Progress & FY 2026 Outlook (ongoing FY 2022-23 to FY 2026-27): The scheme provides 5% incentives on incremental sales of domestically manufactured medical devices across four high-import segments with a total outlay of ₹3,420 crore. As of late 2025, 22 greenfield projects were commissioned and production commenced for 55+ high-end devices including MRI, CT, LINACs, mammography, ultrasound and C-arm, generating cumulative eligible sales of ~₹12,344 crore; medical device exports also grew to US$4.1 billion in FY 2024-25 from US$2.9 billion in FY 2021-22.
- National Conference on Strategic Trade Controls (NCSTC) 2026 – New Delhi (held 15 January 2026): DGFT in collaboration with MEA and FIEO held India’s flagship platform for SCOMET, export controls and strategic trade compliance; 500+ participants from India and abroad covered quantum, advanced computing, semiconductors, additive manufacturing and cybersecurity alongside the Third Edition Handbook on India’s Strategic Trade Control System. Exporters of advanced lab/scientific equipment and high-end medical technologies that may fall under SCOMET must stay current on licensing, end-use declarations and internal compliance architecture.
- 9th Annual Pharma Regulatory Summit 2026 – Mumbai (held 24 March 2026): Conference themed “Driving Regulatory Excellence for a Changing Pharma Landscape,” covering drug-regulation updates, quality, GMP, pharmacovigilance and policy impacts on pharma manufacturing and exports. Equipment suppliers can align documentation and validation support (CSV, data integrity, 21 CFR Part 11) with pharma clients’ regulatory needs identified at this summit.
- Annual Medical Device Regulatory & Quality Summit 2026 (10th Edition – dates TBD): Exclusive platform for regulators and industry to discuss evolving CDSCO rules, BIS standards, quality management, clinical evaluation and market access; informs how medical device manufacturers will interpret new regulatory requirements, shaping compliance-driven demand for testing, lab and QA equipment.
- 9th India Pharma 2026 Conference – New Delhi (held 13–14 April 2026): Flagship policy and industry dialogue co-hosted by DoP, FICCI and IPA, themed “Discover in India: Leapfrogging Life-Sciences Innovation.” Equipment manufacturers can align technology roadmaps – continuous manufacturing, PAT, automation – with the policy direction and innovation priorities that emerged from this high-level conference.
- Pharmexcil Chintan Shivir – “Scaling Up Pharma Exports” (held 4 April 2026) & SSMDI Workshops (held 20 February 2026): Chintan Shivir convened stakeholders to strategise on pharma export growth; the SSMDI workshop at NIPER Hyderabad focused on the Scheme for Strengthening of Medical Device Industry including testing infrastructure, common facilities and skill development. Both events highlight export-oriented and cluster-oriented interventions influencing where device manufacturers invest in testing, compliance and marketing.
- ICMED 13485 Quality Certification & IPC ISO 13485 Certification Services (active 2025-26): ICMED 13485 is a voluntary quality-management certification for Indian device manufacturers integrating ISO 13485 requirements with Indian regulatory specifics; IPC-MDD offers ISO 13485 management system certification with regulatory compliance focus. As more manufacturers pursue ICMED/ISO 13485, they invest in documented QA, validation and testing processes, often upgrading lab and calibration equipment.
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) (draft 10 Apr 2026) | Formalises Certificate of Registration; clarifies testing fees and definitions in MDR 2017 | Consultation window is likely open now; final rules may be notified within weeks, affecting registration workflows and testing cost structures | Monitor the MoHFW Gazette for finalization; review whether Certificate of Registration provisions affect pending import or manufacturing licence applications; update cost models for testing fees |
| GFR Amendment – Raised Limits for Scientific Institutions | Non-GeM procurement allowed; direct purchase to ₹2 lakh; committee to ₹25 lakh; GTE to ₹200 crore | Active procurement cycle at CSIR, ICMR, IITs, ICAR, DRDO continues; institutes can buy faster and at higher values | Deliver GFR-compliant direct-purchase catalogues to DST, ICMR, ICAR, DRDO, DBT purchase officers this month; flag items under ₹2 lakh explicitly for direct-purchase eligibility |
| PLI Medical Devices – Final Year (FY 2026-27); 22 greenfield projects operational | 5% incentive on incremental sales; 55+ device categories in production; ₹12,344 crore eligible sales | PLI-funded MRI, CT, LINAC, mammography, ultrasound facilities need calibration and QA instruments before their final PLI-year audits | Contact PLI-commissioned manufacturers from DoP project list; pitch calibration, QA instrument, and validation equipment packages before final PLI-year production audit cycles (typically Q2–Q3) |
| Customs Duty – Lab Chemicals (10% concessional rate for R&D; 150% general) | Concessional 10% rate for R&D/lab use under undertaking; general commercial imports at 150% | Lab-chemical pricing needs to reflect correct duty structure in all current quotes and contracts | Audit open purchase orders and customer quotes for lab chemicals; confirm applicable duty rate (concessional R&D vs. commercial); update price sheets and notify customers of any pricing changes |
| SSMDI Scheme – ₹500 Crore (cluster lab funding active) | Common testing lab infrastructure in device clusters; proposals under review | 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 for preferred vendor listing on lab instruments and testing equipment |
| BIS 214 Device Standards Programme (ongoing enforcement) | Standards for 214 critical devices; 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/MHD 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 (TDB as second-level fund manager; disbursements active) | Long-tenure low-interest R&D financing; targets biotech, pharma, AI, deep tech | Funded organisations are in equipment acquisition phase following early-2026 disbursements | Register vendor interest at rdifund.anrf.gov.in; monitor TDB/BIRAC for funded project announcements; position advanced analytical, lab automation, and testing instruments with newly funded entities early |
Disclaimer: Policy details are current as of 26 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) | NABL (www.nabl-india.org).