India Government Medical Device Procurement: GeM Platform, Make in India Policy, CGHS/PM-JAY Reimbursement & Market Access Guide (2026)

Why Understanding Indian Government Medical Device Procurement Matters

India is the fourth-largest medical device market in Asia and one of the fastest-growing globally. The Indian medical devices market was valued at approximately USD 14–19 billion in 2025 (estimates vary by source), with projections to reach USD 30–50 billion by 2030–2034. Government healthcare spending is expanding rapidly under initiatives like Ayushman Bharat PM-JAY, which covers over 550 million beneficiaries, and the Production Linked Incentive (PLI) scheme, which has attracted over Rs 4,253 crore (USD 500 million) in realized investment.

Yet India remains 70–85% import-dependent for medical devices, with imports reaching Rs 61,262 crore (USD 7.2 billion) between November 2022 and October 2023. Medical device imports increased by 21% year-over-year, with the trade deficit exceeding Rs 63,200 crore. This creates both a massive opportunity and a complex regulatory environment for foreign manufacturers.

This guide covers the full landscape: how the Government e-Marketplace (GeM) platform works, how Make in India policies shape procurement preferences, how CGHS and PM-JAY reimburse medical devices, and what foreign manufacturers must do to compete in India's government procurement ecosystem.

The Indian Medical Device Procurement Ecosystem

Overview of Procurement Channels

Medical devices reach Indian government end-users through several channels:

Channel	Share of Government Purchasing	Key Actors
GeM (Government e-Marketplace)	Growing rapidly — cumulative GMV ₹18.4 lakh crore	Central/state hospitals, medical colleges, health departments
Centralized agency procurement	Major equipment, vaccines, pharmaceuticals	HLL Medical Services, Medical Services Corporation
State-level tenders	State hospitals and primary health centers	State medical supplies corporations
Direct procurement by institutions	Small-value purchases (below Rs 50,000)	AIIMS, government hospitals, CGHS wellness centers

Key Market Data

Metric	Value
Indian medical device market (2025)	USD 14–19 billion
Projected market size (2034)	USD 31–50 billion
Import dependency	70–85%
Medical device imports (2022–2023)	Rs 61,262 crore (~USD 7.2 billion)
Medical device exports (FY25)	Rs 31,120 crore (~USD 3.6 billion)
PLI scheme realized investment	Rs 4,253 crore (~USD 500 million)
PM-JAY beneficiaries	~550 million
CGHS beneficiaries	~4.3 million
Number of CDSCO-registered medical devices	Thousands (expanding rapidly)

The GeM Platform: India's Digital Procurement Revolution

What Is GeM?

The Government e-Marketplace (GeM) is a digital procurement platform launched by the Government of India to streamline public purchasing. For the medical device industry, GeM has become the primary channel connecting manufacturers, importers, and suppliers directly with government hospitals, health departments, and medical institutions.

GeM has become one of the world's largest public procurement platforms, processing ₹18.4 lakh crore (approximately USD 220 billion) in cumulative orders across all product categories as of 2025–2026.

How GeM Procurement Works for Medical Devices

1. Seller registration — Manufacturers and distributors register on GeM with required documentation (PAN, GST, bank details, product certifications)
2. Product listing — Sellers list medical devices with technical specifications, pricing, and images
3. Buyer requisition — Government hospitals and departments create purchase requisitions on the platform
4. Bidding or direct purchase — Depending on value:
   • Below Rs 50,000: Direct purchase without formal bidding
   • Rs 50,000 to Rs 5 million: Limited tender or bid
   • Above Rs 5 million: Full tender process with mandatory GeM listing
5. Evaluation and award — Bids are evaluated on technical compliance and price (typically L1 — lowest price)
6. Contract and delivery — Purchase order issued, delivery timeline and warranty terms enforced

GeM Global Tendering (GTE)

In a significant policy shift, GeM has introduced Global Tendering (GTE), enabling foreign suppliers to participate in Indian government procurement. This expansion aligns with the India-UK Comprehensive Economic and Trade Agreement (CETA), signed in July 2025, which opens India's procurement ecosystem to UK firms, as well as similar agreements with the UAE and other FTA partners. The platform now supports multi-currency bidding for international sellers. Key requirements for foreign sellers include:

• Registration Verification (RV): Foreign sellers must upload attested, valid documents
• Accepted attestation methods: Apostille, notarization, or embassy attestation
• Price evaluation: Buyers may add import duties, logistics costs, and taxes to ensure uniform comparison with domestic bids
• Contractual compliance: Foreign suppliers must meet Indian contractual and financial requirements

Make in India (MII) Policy in Procurement

India's Make in India policy has profound implications for medical device procurement. Under the Preference to Make in India (PMI/PPP-MII) Order, suppliers are classified into three tiers:

Supplier Class	Local Content Requirement	Preference in Tenders
Class-I Local Supplier	≥50% local content	Highest preference
Class-II Local Supplier	25–49% local content	Second preference
Non-Local Supplier	<25% local content	Lowest preference

Local Content Requirements for Medical Devices

The Department of Pharmaceuticals has prescribed specific local content thresholds by device category:

Device Category	Minimum Local Content (for procurement ≤Rs 50 lakh)
Medical disposables and consumables	50%
Medical electronics, hospital equipment, surgical instruments	25%
Implants	40%
Diagnostic Reagents / IVDs	25%

For procurement above Rs 50 lakh, purchase preference is given to local suppliers, with non-local suppliers eligible only if sufficient local competition does not exist. Local content is calculated based on the ratio of domestic value addition to total value of the device.

Government Health Insurance and Reimbursement

PM-JAY (Ayushman Bharat Pradhan Mantri Jan Arogya Yojana)

PM-JAY is the world's largest government-funded health insurance scheme, providing coverage of Rs 5 lakh (approximately USD 6,000) per family per year for secondary and tertiary care hospitalization.

Key facts:

• 550 million beneficiaries — approximately 40% of India's population
• Covers 1,961 procedures across 27 medical specialties, including surgical packages that incorporate medical devices
• Device costs are bundled into procedure packages — similar to DRG systems in other countries
• Managed by the National Health Authority (NHA)
• The HeFTA (Health Financing and Technology Assessment) unit within NHA is developing medical device reimbursement frameworks

CGHS (Central Government Health Scheme)

CGHS provides comprehensive healthcare coverage to approximately 4.3 million central government employees, pensioners, and their dependents:

• 370 CGHS Wellness Centers across 35 cities
• Reimbursement for medical devices is based on fixed rate lists updated periodically
• CGHS rates are tiered by city (Tier I, II, III) and facility accreditation (NABH vs non-NABH)
• Example CGHS rate differentials:
  • Non-NABH facility: Base rate
  • NABH accredited: +15–20% premium
  • Super specialty: Additional premium
• CGHS rates serve as a reference benchmark for other government procurement

ECHS (Ex-Servicemen Contributory Health Scheme)

ECHS covers approximately 15 million ex-servicemen and their dependents. It adopts CGHS rates for treatment procedures and device reimbursement, providing another significant government procurement channel.

Employee State Insurance Scheme (ESIS)

ESIS covers industrial workers and their families — approximately 149 million beneficiaries. Medical device procurement under ESIS follows state-level tendering processes and CGHS rate benchmarks.

Key Procurement Agencies

HLL Medical Services Ltd (HLL Lifecare)

HLL is a Government of India enterprise under the Ministry of Health and Family Welfare and one of the largest centralized procurement agencies for medical devices and equipment:

• Procures for central government hospitals, AIIMS, and medical colleges
• Conducts large-scale tenders for medical equipment, surgical supplies, and diagnostic devices
• Operates distribution warehouses across India
• Manages the contract manufacturing of medical devices for government use

State Medical Supplies Corporations

Most Indian states operate their own medical supplies corporations or procurement agencies:

• Tamil Nadu Medical Services Corporation (TNMSC) — One of the most transparent and efficient state procurement systems
• Kerala Medical Services Corporation (KMSCL)
• Haryana Medical Services Corporation (HMSCL)
• Rajasthan Medical Services Corporation (RMSC)

These agencies conduct state-level tenders for medical devices used in state hospitals, primary health centers, and district hospitals.

All India Institute of Medical Sciences (AIIMS)

AIIMS and similar autonomous institutions conduct their own procurement for advanced medical equipment, often through GeM or direct tenders published on their institutional websites.

Regulatory Requirements for Market Access

CDSCO Registration

The Central Drugs Standard Control Organization (CDSCO) is the primary regulatory authority for medical devices in India. Since 2020, India has been transitioning to a comprehensive mandatory licensing system:

• All medical devices must be registered with CDSCO (phased implementation through 2026)
• Devices are classified as Class A, B, C, or D based on risk (aligned with GHTF/IMDRF framework)
• Foreign manufacturers must appoint an Authorized Agent in India
• ISO 13485 compliance is essential
• UDI (Unique Device Identification) codes are now mandatory

BIS Certification

The Bureau of Indian Standards (BIS) certification is required for certain categories of medical devices. BIS publishes standards for medical equipment and hospital planning (Medical Equipment and Hospital Planning Division — MHD). Compliance with relevant Indian Standards (IS) is mandatory for products covered by BIS notifications.

Import Requirements

• Import license from CDSCO required for all imported medical devices
• Registration certificate must be obtained before importation
• Labeling must comply with Indian regulations and include:
  • Manufacturer and importer details
  • License number
  • Batch/lot number
  • Instructions for use in English (regional language for certain devices)

Tendering Procedures and Compliance

Types of Tenders

Tender Type	Value Threshold	Process
Direct purchase	Below Rs 50,000	No formal bidding required
Limited tender	Rs 50,000 – Rs 5 million	Local purchase committee
Open tender	Above Rs 5 million	Full competitive bidding on GeM/CPPP
Global tender	Case-by-case	Open to international bidders

Essential Compliance Requirements

1. Digital Signature Certificate (DSC) — Class III DSC required for e-tendering on GeM
2. Earnest Money Deposit (EMD) — Security deposit required with bid submission
3. Performance Bank Guarantee (PBG) — Required post-award to ensure contract compliance
4. GST compliance — GSTIN and tax return filing evidence mandatory
5. Financial statements — Audited balance sheets for preceding 3 years
6. Turnover criteria — Minimum average annual turnover threshold specified in each tender
7. Past performance — Purchase orders, invoices, and performance certificates from previous government contracts
8. Quality certifications — ISI, BIS, or relevant standards compliance

Make in India Compliance in Tenders

For tenders subject to MII provisions, bidders must:

• Submit self-certification of local content percentage (audited certificates increasingly required)
• Provide Chartered Accountant certification for high-value tenders
• Demonstrate domestic value addition through manufacturing documentation
• DPIIT-registered startups receive relaxation from turnover criteria

Pricing Considerations

Government Price Controls

India does not have a centralized medical device pricing authority equivalent to NICE (UK) or HAS (France), but several mechanisms influence pricing:

• CGHS rate lists — Serve as de facto price ceilings for government procurement
• PM-JAY package rates — Bundle device costs into procedure packages, creating implicit price limits
• GeM price discovery — The platform's competitive bidding drives prices to market-clearing levels
• Trade Margin Rationalization — Government has considered capping trade margins on certain medical devices (e.g., coronary stents, knee implants)

Price Strategy for Government Tenders

• Research CGHS rates before bidding — these set expectations
• Factor in Make in India advantages — local manufacturing can provide 10–20% preference margins
• Offer volume discounts — Government tenders are often large-volume, long-term contracts
• Include total cost of ownership — Service, warranty, spare parts, and training can differentiate your bid beyond the lowest unit price

Requirements and Opportunities for Foreign Suppliers

Market Entry Pathways

1. Direct GeM registration — Register as a foreign seller for Global Tenders (GTE)
2. Local distributor partnership — Appoint an Indian distributor with CDSCO registration and GeM access
3. Indian subsidiary — Establish a local Indian entity (Private Limited Company) to qualify as a local supplier
4. Contract manufacturing — Partner with Indian manufacturers to produce devices locally and qualify for MII preferences

The PLI Scheme Opportunity

The Production Linked Incentive (PLI) scheme for medical devices offers significant incentives for companies establishing manufacturing in India:

• Total allocation: Rs 3,420 crore (original) with increased investment to Rs 1.97 lakh crore total
• 22 greenfield manufacturing projects commissioned as of 2025
• 55+ medical devices now produced domestically, including MRI scanners, CT scanners, mammography systems, C-arm X-ray machines, and linear accelerators
• Cumulative eligible sales: Rs 123.44 billion as of September 2025
• Export component: Rs 58.69 billion from PLI-supported manufacturing

Strategic Recommendations

1. Establish local manufacturing or assembly — Even partial local content can shift your classification from Non-Local to Class-II or Class-I supplier
2. Register on GeM early — The platform is increasingly mandatory for government procurement
3. Build a portfolio of government references — Start with smaller state-level tenders before pursuing large central government contracts
4. Engage with the PLI scheme — If manufacturing high-end devices, PLI incentives can make local production economically viable
5. Partner strategically with distributors — Choose distributors with strong government relationships and CDSCO/BIS compliance capabilities

Key Government Agencies and Organizations

Organization	Role
GeM	Government e-Marketplace — digital procurement platform
CDSCO	Medical device regulation and registration
BIS	Bureau of Indian Standards — product certification
NHA	National Health Authority — PM-JAY administration
HLL Medical Services	Centralized procurement agency
Department of Pharmaceuticals	PLI scheme, MII policy for medical devices
DPIIT	Startup registration, MII policy oversight
State medical supplies corporations	State-level procurement

Summary: Navigating the Indian Market

India's government medical device procurement landscape is undergoing rapid transformation:

1. GeM is becoming mandatory — All government procurement is migrating to the digital platform, and foreign suppliers can now participate through Global Tenders
2. Make in India policies create both barriers and opportunities — Local content requirements favor domestic manufacturers, but the PLI scheme offers incentives for foreign companies to establish local production
3. PM-JAY is expanding device coverage — As the world's largest health insurance scheme matures, device-specific reimbursement pathways are developing
4. Price sensitivity is extreme — Government tenders are driven by L1 (lowest price) logic, making cost competitiveness essential
5. Regulatory requirements are tightening — CDSCO registration is now mandatory for all medical devices, with phased implementation through 2026

For foreign manufacturers, success in India requires navigating a complex web of regulatory, procurement, and reimbursement systems. The companies that invest early in local partnerships, GeM registration, and MII compliance will be best positioned to capture this rapidly growing market.