GOVERNMENT POLICIES, REFORMS & FUNDING INITIATIVES
Policy Summaries
- Draft Medical Devices Rules Amendment 2026 – G.S.R. 270(E) (draft notified 10 April 2026): This draft amends the Medical Devices Rules 2017, introducing a formal definition for “Certificate of Registration,” mandating labelling of outsourced sterilisation site licence numbers, and adding a new Ninth Schedule that specifies fees for testing and evaluation of devices at government and designated testing laboratories. It directly tightens labelling transparency when sterilisation is outsourced and clarifies fee structures – affecting compliance timelines and cost planning for SIDMA manufacturers and importers of sterile medical devices.
- Draft Medical Devices Rules Amendment 2026 – G.S.R. 269(E) (draft notified 10 April 2026): A companion amendment to G.S.R. 270(E) that modifies headings and provisions related to Government Medical Device Testing Laboratories, embeds Quality Management System (QMS) requirements into rules 19H and 19J, and extends recognition of foreign conformity assessment from certain EU countries for testing equivalence purposes. This signals stronger alignment of India’s device-testing framework with international QMS norms and may allow some devices to leverage recognised foreign test data, reducing duplicative testing burdens for importers.
- PLI Scheme for Medical Devices – November 2025 Performance Update (ongoing FY 2022-23 to FY 2027-28): Under the PLI scheme, 32 medical device applicants were selected; 19 greenfield projects have been commissioned for 44 high-end products including linear accelerators, MRI machines, CT scanners, mammography systems, C-arms, ultrasound and X-ray equipment. The scheme has realised over ₹1,057 crore of the committed ₹1,356.94 crore investment and generated cumulative sales of approximately ₹8,039.63 crore, including exports worth approximately ₹3,844.01 crore. Supported product categories include imaging and diagnostics, critical care, interventional cardiovascular, renal care, orthopaedic implants and oncology equipment.
- State-Level Assistance to R&D Laboratories – Gujarat (active 2026): The Gujarat government’s “Scheme for Assistance for Research & Development Activities” provides financial assistance to R&D institutions and laboratories established or supported by the state to strengthen research capacity. While specific subsidy and capital-support details are not fully elaborated in the brief listing, such schemes typically support equipment acquisition and lab infrastructure investment within Gujarat’s state-backed R&D ecosystem.
- BIS & NABL – Medical Device Standards Drive (214 Critical Devices; SUGAM Portal Relaunch): BIS is fast-tracking certification norms for 214 critical medical devices by December 2025, while CDSCO and NABL have integrated reclassifications and digital processes including the relaunched SUGAM portal (operational from 9 April 2025) for market-standing and non-conviction certificates. The programme aims to tighten quality norms, standardise device categories and streamline approvals across a broad range of hospital equipment, diagnostics and scientific instruments.
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 Ninth Schedule testing fees | 30-day consultation window from 10 April 2026 has closed; final notification may arrive imminently, changing compliance costs and labelling requirements | Monitor MoHFW Gazette for finalisation; update sterilisation-site labelling on all sterile device packaging; review testing-fee impact on costing models for devices requiring third-party evaluation |
| Draft MDR Amendment G.S.R. 269(E) – QMS in Testing Labs + EU Conformity Recognition | Embeds QMS requirements in device testing rules; recognises EU conformity assessment for testing equivalence | Final notification expected soon; QMS documentation expectations for testing labs will tighten; EU-conformity recognition may reduce duplicative testing costs | Review QMS documentation for any devices sent to government testing labs; identify which EU-conformity certificates may substitute for certain Indian tests under the new recognition provisions |
| PLI Medical Devices – Final Extended Year (to FY 2027-28); 19 greenfield projects; 44 devices in production | Production incentives for high-end imaging, diagnostic and critical-care devices; ₹8,039 crore cumulative sales | PLI-funded MRI, CT, LINAC, mammography, ultrasound and X-ray manufacturers are in active production and need calibration, QA and validation instruments | Contact PLI-commissioned manufacturers from DoP’s published project list; pitch calibration, QA instrument and validation equipment packages – these facilities are active buyers in their ramp-up phase |
| BIS 214 Device Standards Programme + SUGAM Portal (NABL/CDSCO integration) | Standards for 214 critical devices; SUGAM portal automated for Market Standing Certificates and Non-Conviction Certificates | Tenders in Q2-Q3 2026 are requiring BIS compliance certificates; SUGAM-issued certificates now mandatory for procurement 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; register for SUGAM portal access if not yet done |
| Gujarat State R&D Assistance Scheme (active 2026) | Financial assistance for Gujarat state-backed R&D institutions and laboratories; supports equipment acquisition and lab infrastructure | Gujarat R&D labs supported by this scheme are in procurement cycles for lab instruments and infrastructure | Identify Gujarat state-supported R&D institutions eligible under this scheme; contact their purchase officers with targeted lab instrument offerings; check myscheme.gov.in (SARDARDL scheme) for eligible institution lists |
Disclaimer: Policy details are current as of 24 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) | myScheme (www.myscheme.gov.in).