Policy Summaries

• PLI Scheme for Medical Devices – Progress & FY 2026 Outlook (ongoing FY 2022-23 to FY 2027-28): With a total outlay of ₹3,420 crore offering 5% incentives on incremental sales, the scheme has resulted in 32 applicants selected, 19+ greenfield projects commissioned, and production commenced for 44-55 high-end devices (MRI, CT, mammography, C-arm, ultrasound, LINACs), generating cumulative eligible sales of ~₹12,344 crore including exports of ~₹5,869 crore by September 2025. This strengthens domestic manufacturing capability for advanced imaging and therapeutic devices, creating upstream demand for components, calibration equipment and QA instrumentation from SIDMA members.
• GeM Global Tendering Expansion and Multi-Currency Bidding (FY 2025-26): GeM has processed approximately ₹18.4 lakh crore (~USD 220 billion) in cumulative orders by 2025-26; new rules introduce Global Tendering Enabling (GTE) allowing foreign suppliers (starting with India-UK, UAE and other FTA partners) to participate, with multi-currency bidding for international sellers. While beneficial for government buyers, this increases competition for Indian suppliers in medical devices and lab equipment tenders – SIDMA members must emphasise Make-in-India local content advantages, pricing and service to remain competitive.
• BIS Standards for Medical Devices and Customs Duty Updates (2025-26): BIS has continued expanding and updating medical device standards under the MHD series (including IS 10272:2025 for Draffin suspension apparatus and other device-specific standards), tightening quality and safety requirements; customs notifications in 2025 also amended duties on various industrial and chemical imports, including adjustments in lab-chemical duty structures and exemptions for specific manufacturing equipment. Device manufacturers and importers must ensure compliance with new BIS device standards and account for customs duty changes in pricing imported lab chemicals and components.
• NCSTC 2026 – National Conference on Strategic Trade Controls (held January 2026): DGFT in collaboration with MEA and FIEO brought together policymakers, regulators, industry representatives and experts to review India’s strategic trade control framework; sector-specific sessions covered electronics/IT, biotechnology, chemicals, aerospace and defence, with the third edition of the Handbook on India’s Strategic Trade Control System released. Exporters of high-end scientific instruments, biotech equipment and advanced lab systems that may fall under SCOMET must stay current on licensing, end-use declarations and internal compliance architecture from this annual conference.
• 9th Annual Pharma Regulatory Summit 2026 (held 24 March 2026, Mumbai): Industry and regulatory conference themed “Driving Regulatory Excellence for a Changing Pharma Landscape,” focused on drug-regulation updates, quality, GMP, pharmacovigilance and changing regulatory expectations for pharma companies. Equipment suppliers can align documentation and validation support (CSV, data integrity, 21 CFR Part 11) with pharma clients’ regulatory needs identified at this summit.
• 9th India Pharma 2026 Conference (held 13-14 April 2026, New Delhi): Flagship policy and industry dialogue platform themed “Discover in India: Leapfrogging Life-Sciences Innovation,” co-hosted by DoP, FICCI and IPA, focused on transitioning India from volume-driven to value- and innovation-led pharma. Equipment manufacturers can align technology roadmaps – continuous manufacturing, PAT, automation – with the policy narratives and direction signals from this conference.
• FICCI Advantage Healthcare 2026 (held 23-25 February 2026, Greater Noida): Flagship FICCI summit on medical value travel, hospital quality, digital health and India’s global healthcare positioning, featuring regulatory, accreditation and quality perspectives. Indirectly relevant for SIDMA via hospital-infrastructure investments and international patient-care positioning, which drive demand for high-quality medical and diagnostic equipment.
• ICMED 13485 & ICMED 13485 Plus – Indian Certification for Medical Devices (active 2025-26): ICMED 13485 is a quality-management certification integrating ISO 13485 with Indian regulatory requirements; ICMED 13485 Plus extends this with product-level quality validation and witness testing, creating an end-to-end assurance scheme. Device manufacturers and OEMs in SIDMA’s network benefit from stronger quality signalling to domestic and international buyers; distributors can preferentially partner with ICMED-certified manufacturers.
• BIS Certification for Medical Devices – CRS and Device-Specific Standards (2025-26 Updates): BIS has been rolling out updated medical device certification requirements under the Conformity Assessment scheme and device-specific standards, aligning with international frameworks and CDSCO mandates. Device OEMs served by SIDMA will increasingly require BIS-compliant components and subsystems, and SIDMA’s instrumentation and accessories should align to BIS requirements to remain preferred suppliers.

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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
SCOMET Category 7 (effective 23 Oct 2025) – Quantum, Semiconductors, Cryogenic, Additive Manufacturing	New export-control category requiring DGFT licences for listed items; exporters must classify and comply	Retroactive compliance exposure for any shipments since Oct 2025 of potentially controlled items	Audit all export invoices since 23 Oct 2025 at www.dgft.gov.in; obtain retroactive and prospective licences; classify all high-end analytical, cryogenic, and precision instruments against Category 7 before next shipment
PLI Medical Devices – Final Year (FY 2026-27); 19+ greenfield projects; ₹12,344 crore eligible sales	5% incentive on incremental sales; 44-55 device categories in production	PLI-funded imaging and therapeutic device facilities are in active production ramp-up and need calibration, QA, and validation instruments – this window closes when PLI ends	Contact PLI-commissioned manufacturers (MRI, CT, LINAC, mammography, ultrasound) from DoP’s project list; pitch calibration, QA instrument, and validation equipment packages before their first full-year PLI audit
GFR Amendment – Raised Limits & Non-GeM Procurement for Scientific Institutions	Non-GeM procurement allowed for specialists; direct purchase to ₹2 lakh; committee to ₹25 lakh; GTE to ₹200 crore	Active procurement cycle at CSIR, ICMR, IITs, ICAR, DRDO – faster and higher-value purchasing now permitted	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
GeM Global Tendering (GTE) – Foreign Suppliers Now Allowed	FTA partners (UK, UAE) can now bid on GeM tenders for government purchases	Indian suppliers face direct foreign competition in GeM medical equipment tenders in the next 60 days	Ensure GeM listings emphasise local manufacturing, Make-in-India status, service network, and support – competitive differentiators that foreign bidders cannot easily match
BIS Device Standards – MHD Series Updates (2025-26)	Updated device-specific standards tightening quality and safety; BIS standards embedded in CDSCO evaluations and government tenders	Q2 2026 tenders are now 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
ICMED 13485 Certification – Increasingly Required for Export and Government Procurement	ISO 13485-aligned voluntary Indian quality certification; increasingly specified by government and export buyers	MENA and Southeast Asia export buyers encountered at analytica Mumbai and Pharmalabchem Navi Mumbai are requesting ICMED or ISO 13485 proof	Initiate ICMED 13485 application with NABCB-accredited body (Intertek, UL India) if not yet certified; use post-analytica Mumbai buyer follow-ups as the business trigger
RDI Fund – ₹1 Lakh Crore (initial disbursements via TDB and BIRAC)	Long-tenure low-interest R&D financing for TRL4+ projects in AI, biotech, quantum, medical devices	Funded organisations are in equipment acquisition phase following early-2026 disbursements	Register vendor interest at rdifund.anrf.gov.in; monitor ANRF/TDB/BIRAC project approvals; position advanced analytical, lab automation, and testing instruments with newly funded entities

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Disclaimer: Policy details are current as of 20 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).