§1How big it is

§2Ways to get started

  • Class A/B consumables (dressings, cotton, masks)
  • Diagnostic kit assembly
  • Hospital furniture and non-electrical equipment
  • Device distribution with service (biomedical maintenance)
  • Contract manufacturing in a medical device park

See the Business Encyclopedia

§3Hubs and clusters

  • Medical device parks: Greater Noida (UP), Ujjain (MP), Kanchipuram (TN)
  • Established manufacturing hubs named by PIB: Maharashtra, Gujarat, Telangana, Karnataka, Andhra Pradesh (incl. AMTZ Visakhapatnam)

§4Licences and registration

  1. Manufacturing licence under Medical Devices Rules 2017 - Class A/B from State Licensing Authority, Class C/D from CDSCO (via SUGAM / online portal)
  2. Registration of Class A (non-sterile, non-measuring) devices on the CDSCO online portal
  3. ISO 13485 quality management system (expected under MDR)
  4. Import licence (for imported devices) from CDSCO
  5. BIS certification where a QCO covers the product
  6. Udyam Registration (MSME) - free, online, PAN + Aadhaar based
  7. GST registration (mandatory above turnover threshold or for inter-state supply / e-commerce sale)
  8. Shops & Establishment registration or Factory Licence (Factories Act / state rules) depending on size and power use
  9. Consent to Establish and Consent to Operate from the State Pollution Control Board - category (Red/Orange/Green/White) as per CPCB 2025 harmonised list; White category is exempt from consent
  10. IEC (Importer Exporter Code) from DGFT if you import or export

§5Regulators

  • CDSCO (Medical Devices Rules 2017 - risk classes A, B, C, D)
  • State Licensing Authority (Class A and B manufacturing)
  • BIS (some device standards)
  • NPPA (price monitoring of notified devices)

§6Government help

  • PLI Scheme for Promoting Domestic Manufacturing of Medical Devices
  • Scheme for Promotion of Medical Devices Parks (Rs 100 crore grant per park)
  • Strengthening of Medical Device Industry scheme (common facilities, testing, skilling) - check status
  • PRIP (research and innovation)
  • Public procurement preference (Make in India order)
  • Cross-sector schemes that also apply (detailed in the programmes file): Udyam benefits, PMEGP, PM Mudra Yojana, CGTMSE credit guarantee, Stand-Up India, MSE-CDP (cluster development), RAMP, MSME ZED and Lean certification, MSME Champions, TReDS, Startup India (SISFS seed fund, Fund of Funds, CGSS), RoDTEP, EPCG, Advance Authorisation, Districts as Export Hubs, ODOP (One District One Product)

All schemes

§7For exports

  • EPCES / Pharmexcil (medical devices panels)

§8Pros and cons

Merits

  • Exports grew from USD 2.5 bn to 4.1 bn between 2020-21 and 2024-25 [PIB Mar 2026]
  • Ready plots and common testing labs in 3 device parks lower entry cost [PIB Mar 2026]

Demerits

  • Licensing is risk-class based and Class C/D approvals are slow and technical
  • High import dependence for components and electronics
  • Hospitals buy on price; tender-driven sales with delayed payments

Sources

  1. PIB backgrounder: India's Pharmaceuticals in Global Healthcare (21 Mar 2026)
  2. CDSCO - Central Drugs Standard Control Organisation