Policy Summaries

• CDSCO Medical Device Regulatory Framework – Risk Classification, UCMPMD, Materiovigilance & SUGAM Digitalization (2024-2026): India introduced a risk-based surveillance strategy for imported medical devices with stricter controls for high-priority products, updated risk-classification lists for 550+ cardiovascular and neurological devices, and a new Uniform Code for Marketing Practices in Medical Devices (UCMPMD) restricting unethical promotion. CDSCO also fully digitalised Market Standing Certificates and Non-Conviction Certificates via the relaunched SUGAM portal from April 2025, and intensified post-market surveillance through a revamped Materiovigilance adverse-event reporting format and expert committee.
• National Conference on Strategic Trade Controls (NCSTC) 2026 – New Delhi (held 15 January 2026): DGFT in collaboration with MEA and FIEO convened NCSTC 2026 to review India’s Strategic Trade Control framework, especially SCOMET-regulated exports of dual-use and sensitive items, and emerging technologies including semiconductors, quantum, and additive manufacturing. 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 NCSTC outcomes and DGFT circulars.
• PLI Scheme for Promoting Domestic Manufacturing of Medical Devices – FY 2026 Progress (ongoing FY 2022-23 to FY 2026-27): The PLI scheme provides financial incentives to boost domestic manufacturing of 36 high-end medical devices across imaging & diagnostics, critical care, interventional cardiology, renal care and orthopaedic implants, with incentive disbursements of approximately ₹157.15 crore by December 2025. Devices manufactured under the scheme are reported to be 10-30% cheaper than comparable imports; dedicated medical device parks in Uttar Pradesh, Madhya Pradesh and Tamil Nadu are being developed with subsidised land, shared high-end infrastructure (sterilisation, biocompatibility, EMC testing) and subsidised utilities.
• Proposed Medical Device Regulatory Amendments 2026 – Perpetual Validity Licences (draft proposals, expected notification 2026): SIDMA’s policy tracker notes draft proposals from CDSCO/Department of Pharmaceuticals that would move manufacturing and import licences toward perpetual validity, reducing the need for periodic renewals and aligning more closely with global practices. Additional changes may rationalise regulatory oversight and licensing conditions; distributors would benefit from more stable licensing status of represented OEMs but must monitor for any tightened quality or vigilance obligations attached to longer-term licences.

---

Actionable Policy Table

Policy / Reform	What It Does	Why It Matters in the Next 60 Days	Key Action for SIDMA Members
GFR Special Provisions – Scientific Equipment Procurement (non-GeM; GTE up to ₹200 crore)	Doubles direct-purchase limits; allows non-GeM procurement for research equipment; raises committee and tender thresholds	Active procurement cycle at CSIR, ICMR, IITs, ICAR, DRDO – faster and higher-value purchasing is now possible; this is the fastest institutional sales cycle currently available	Deliver GFR-compliant direct-purchase catalogues to DST, ICMR, ICAR, DRDO, DBT purchase officers by end of May 2026; flag items under ₹2 lakh explicitly for direct-purchase eligibility with a one-page GFR-eligible product sheet
CDSCO Risk Classification + SUGAM Portal Relaunch + UCMPMD (2024-2026)	550+ devices reclassified; SUGAM fully automated; UCMPMD restricts marketing practices; Materiovigilance reporting strengthened	Q2 2026 government tenders and procurement are actively checking licence validity and BIS/risk-class compliance; non-compliant products lose eligibility	Verify all device import licences are in Form MD-15 on relaunched SUGAM portal; confirm correct risk class at cdscomdonline.gov.in for every product before the next submission or tender response
PLI Medical Devices – Final Year (FY 2026-27); 36 device types; ₹157.15 crore disbursed	5% incentive on incremental sales; 24+ greenfield projects; device parks in UP, MP, TN with shared testing infrastructure	PLI-funded imaging, diagnostic and critical-care device manufacturers are in active ramp-up and need calibration, QA and validation instruments before final-year PLI audits	Contact PLI-commissioned manufacturers using DoP’s project list; pitch calibration, QA instrument and validation equipment packages before their year-end PLI performance review; target device park common facilities for shared testing equipment supply
PRIP Scheme – R&D Support for Novel Medical Devices (NIPER CoE active)	Financial support for novel device R&D; industry-academia collaboration at NIPERs; emerging OEMs being created	PRIP-funded projects at NIPER Ahmedabad and other institutions are moving from research to prototyping phase – instrumentation procurement follows	Monitor DoP PRIP grant announcements; contact NIPER Ahmedabad and NIPER Hyderabad research groups for early instrument supply conversations; identify PRIP-backed device startups as future OEM partners
BIS 214 Device Standards + 16 Updated Standards (transition deadline late 2025; enforcement 2026)	214 new device standards; 16 updated standards in April-June 2025 with older versions phased out; BIS standards checked in tenders	Q2-Q3 2026 tenders are now requiring current BIS compliance certificates; products using phased-out older standard versions are non-compliant	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; confirm transition status for products previously certified under phased-out standards
Proposed Perpetual Validity Licences (MDR Amendment – draft 2026)	Manufacturing and import licences would become perpetual, reducing renewal friction	Final notification expected in 2026; licence renewal cycles and compliance cost planning should account for this potential change	Monitor MoHFW Gazette for formal notification of perpetual licence provisions; if pending licence renewals are imminent, consult your regulatory advisor on whether to renew under current rules or wait for perpetual licence provisions
SCOMET – NCSTC 2026 Outcomes & Dual-Use Equipment Controls	India’s SCOMET regime covers advanced lab instruments, nuclear-related measuring devices and dual-use electronics; NCSTC 2026 updated compliance expectations	Any export since SCOMET updates of potentially controlled high-end scientific equipment without a DGFT licence is a live customs exposure	Audit all export shipments since October 2025 for SCOMET compliance at www.dgft.gov.in; obtain retroactive and prospective licences; download the Third Edition Handbook on India’s Strategic Trade Control System from NCSTC 2026 and train sales/logistics teams

---

Disclaimer: Policy details are current as of 12 May 2026. Cross-reference with: DGFT (www.dgft.gov.in) | CDSCO (www.cdscomdonline.gov.in) | BIS (www.bis.gov.in) | DoP (www.pharmaceuticals.gov.in) | PHARMEXCIL (www.pharmexcil.com).