Indian import policy
As of 2026-11: imported medical devices need a CDSCO import licence (Form MD-14 application → MD-15 licence via the SUGAM portal) for each manufacturer, site and product, held by the Indian importer; Class A non-sterile, non-measuring devices are exempt from licensing but subject to registration/self-certification requirements (secondary sources — confirm on CDSCO). Labelling must follow the Medical Devices Rules 2017; retail packs also need Legal Metrology declarations. Sources: https://cdsco.gov.in/opencms/opencms/en/Medical-Device-Diagnostics/; https://cdscoonline.gov.in; research/06-compliance-logistics.md.
Check the current DGFT, BIS and CBIC notifications before contracting.
Importing medical consumables & class a/b devices into India: requirements
| Requirement | Authority | Document |
|---|---|---|
| Importer-Exporter Code; GST; ICEGATE | DGFT / GSTN / CBIC | IEC; GSTIN; ICEGATE DSC registration |
| Import policy classification | DGFT | ITC(HS) policy: Free/Restricted/Prohibited/STE; import authorisation if Restricted |
| Customs declaration & duty | CBIC / ICEGATE | Bill of Entry; BCD + AIDC + SWS(10% of BCD) + IGST |
| Import licence | CDSCO | MD-14 application / MD-15 licence |
| Equipment Type Approval | DoT WPC via SARAL Sanchar | ETA self-declaration + import undertaking |
| Trusted trader status | CBIC | AEO-T1/T2/T3/LO |
Import trend
Rajya Sabha 29 Jul 2025: electromedical USD 5,284 mn + surgical instruments USD 263 mn FY25 (FY24: 5,408 + 205); ~70% import dependence
Where Indian buyers are
Delhi NCR — Delhi, Gurugram, Noida. Large hospital chains, government procurement and medical distributors
Maharashtra — Mumbai, Pune. Hospital chains, distributors, diagnostic labs
Tamil Nadu — Chennai, Coimbatore. Hospital networks and medical tourism
Karnataka / Telangana — Bengaluru, Hyderabad. Hospital chains and diagnostic networks
West Bengal / Gujarat — Kolkata, Ahmedabad. Regional distributors and hospitals
Frequently asked questions
What licence is needed to import Class B medical devices into India?
A CDSCO import licence in Form MD-15, applied for in Form MD-14 on the SUGAM portal. It covers specific products from a specific manufacturing site and is held by the Indian importer.
Are Class A medical devices exempt from import licensing?
Class A devices that are non-sterile and non-measuring are exempt from licensing but must meet registration or self-certification requirements. Sterile or measuring Class A devices still need an MD-15 licence.
Do medical devices need BIS certification?
Medical devices are regulated by CDSCO under the Medical Devices Rules 2017, not through BIS QCOs. Some electrical equipment may also need separate checks.
Can I import medical consumables under my own brand?
Yes, but the CDSCO licence and labelling must identify the actual manufacturer and site. Changing the manufacturer means a new or amended licence.
What documents does CDSCO need from the foreign manufacturer?
Typically a Power of Attorney to the Indian agent, ISO 13485 certificate, free-sale certificate or CE/FDA approval, device master file, plant master file and labels.
Import routes
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