Export medical and surgical instruments

What is exported

India exports disposable syringes and needles, catheters, cannulae, surgical and dental instruments and electro-medical equipment. In 2025-26 India exported about US$ 1.5 billion under HS 9018; the USA led, followed by Germany, the Netherlands, Brazil and China. Every importing country treats these as medical devices and requires registration before sale.

Varieties, grades and forms

• Syringes and needlesDisposable and auto-disable syringes, hypodermic and suture needles.
• Catheters and cannulaeIV cannulae, urinary and cardiac catheters.
• Surgical and dental instrumentsForceps, scissors, retractors, orthopaedic and dental tools.
• Electro-medical equipmentECG machines, monitors, BP apparatus, dialysis equipment.

Where it is grown or made

• GujaratAhmedabad, Vadodara and Gandhinagar
• Andhra Pradesh and TelanganaAMTZ Visakhapatnam; Hyderabad (Sultanpur medical devices park)
• Haryana and Delhi NCRFaridabad, Gurugram and Noida — syringes and disposables
• Tamil Nadu and KarnatakaChennai and Bengaluru

The quality buyers ask for

Risk class

Device class under the buyer's rules (EU I/IIa/IIb/III; US I/II/III; India A–D)

Materials

Surgical stainless steel (for example AISI 410/420 for instruments), medical-grade polymers

Sterility

Sterility assurance level 10⁻⁶ by EO or gamma, validated per ISO 11135 / ISO 11137

Biocompatibility

ISO 10993 tests for patient-contact items

Syringe standards

ISO 7886 (syringes), ISO 7864 (needles), ISO 7886-3 for auto-disable types

Certificates

• CDSCO manufacturing licence (Medical Devices Rules, 2017)RequiredNeeded to make medical devices in India.
• ISO 13485RequiredMedical device quality system; required by almost every importer and regulator.
• CE marking under EU MDR 2017/745Often askedRequired for the EU; needs a notified body for most classes above Class I.
• US FDA registration, listing and 510(k)Often askedRequired for the US market; Class II devices usually need 510(k).
• Free sale certificate (CDSCO)Often askedMany importing countries ask for it to register a device.
• WHO PQS (for some immunisation devices)Often askedAuto-disable syringes supplied to UN programmes need WHO PQS prequalification.

Shipping, storage and shelf life

What goes on the pack and carton

• Device name, model, lot, expiry, sterilisation method, "single use" and maker's name and address.
• EU: CE mark with notified-body number, EU representative, UDI and ISO 15223-1 symbols.
• USA: FDA labelling rules (21 CFR 801) and UDI.

Benefits of exporting this product

• RoDTEP: 0.5% of FOB

  Tariff item 9018 90 99 (other medical and surgical instruments) earns 0.5% of FOB value, with no rupee cap, as a duty credit scrip on ICEGATE. Most 9018 lines, such as syringes (9018 31 00), carry 0.5%; cannulae (9018 39 30) carry 0.9%. These rates continue to 31 Dec 2026 (DGFT Notification 41/2026-27). Confirm your exact 8-digit line on the DGFT RoDTEP page before you price an order.

  DGFT — Appendix 4R, RoDTEP schedule for DTA exports w.e.f. 10.10.2024 (Notification 32/2024-25); rates continued to 31.12.2026 by Notification 41/2026-27 ↗
• Duty drawback: 1.2% of FOB

  Drawback item 9018 (medical, surgical, dental and veterinary instruments) has an All Industry Rate of 1.2% of FOB, paid into your bank account. It is not available on exports under Advance Authorisation or from EOU/SEZ units. Check the current schedule on the CBIC drawback page before shipping.

  Gazette of India — Notification 77/2023-Customs (N.T.) dated 20.10.2023: All Industry Rates of duty drawback ↗
• PLI scheme for manufacturers

  The PLI scheme for manufacturing of medical devices is one of the 14 Production Linked Incentive schemes listed by the Government (PIB, December 2024). The incentive goes only to approved manufacturers on their eligible sales, not to traders, but it is why new export-grade capacity is coming up — a useful source of supply for a merchant exporter. Check the scheme guidelines and current status on the ministry's site.

  PIB — Scaling New Heights: How the PLI Scheme is Reshaping Industries (21 Dec 2024), list of the 14 PLI sectors ↗

Where to register

• EEPC IndiaMedical, surgical and other instruments are listed under EEPC in Appendix 2T; take your RCMC from EEPC.eepcindia.org ↗
• CDSCO / State Licensing AuthorityManufacturing licence under the Medical Devices Rules, 2017; CDSCO also issues the free sale and market standing certificates many importing countries ask for. Electronic medical equipment can also join ESC; disposable syringes and medical plastics are under PLEXCONCIL in Appendix 2T.cdsco.gov.in ↗

Quality and checks

• EU: CE marking under the Medical Device Regulation (EU) 2017/745, with a notified body for most classes above Class I, an EU authorised representative and EUDAMED registration.
• USA: FDA establishment registration and device listing; most Class II devices need 510(k) clearance.
• ISO 13485 quality system, sterilisation validation (ISO 11135 or ISO 11137) and biocompatibility (ISO 10993) for sterile and patient-contact items.

Where new exporters go wrong

• Shipping before the device is registered in the buyer country — it cannot be sold or cleared.
• Sterile goods without validated sterilisation records and expiry dates on labels.
• Buying from an unlicensed workshop — buyers and regulators check the CDSCO licence.

Documents this product needs

• Proforma invoice
• Purchase order (PO)
• Certificate of origin (CoO)
• Inspection / quality certificate
• Marine insurance certificate
• Letter of credit (LC)
• Air waybill (AWB)

Schemes that apply

• RoDTEP Remission of Duties and Taxes on Exported Products
• Drawback Duty Drawback (All Industry Rates)
• Advance Authorisation Advance Authorisation
• EPCG Export Promotion Capital Goods Scheme
• ECGC ECGC export credit insurance for small exporters
• LUT Letter of Undertaking for zero-rated exports under GST
• Status Holder Status Holder certificate (One to Five Star Export House)
• MAI / MAS Market Access Initiative (now Market Access Support under EPM)