Medical device imports in India are regulated under the Medical Devices Rules, 2017 (MDR 2017) administered by CDSCO. From January 2020, all medical devices require either CDSCO registration or an import license before customs clearance. This guide covers the regulatory framework, duty rates, HS classification, and practical import checklist.
MDR 2017 Device Classification
| Class | Risk Level | Examples | Registration Required |
|---|---|---|---|
| Class A | Low risk | Bandages, tongue depressors | Self-certification (no CDSCO license for some) |
| Class B | Low-moderate | Syringes, blood glucose meters | CDSCO registration mandatory |
| Class C | Moderate-high | Orthopaedic implants, dialysis | CDSCO registration mandatory |
| Class D | High risk | Pacemakers, stents, cardiac devices | CDSCO registration mandatory |
HS Classification and Duty — Medical Devices
| Device | HS Code | BCD | IGST |
|---|---|---|---|
| Surgical instruments | 9018 | 0% | 12% |
| X-ray equipment | 9022 | 0% | 12% |
| MRI / CT scanners | 9018.12 / 9022 | 0% | 12% |
| Cardiac stents | 9021.90 | 0% | 5% |
| Orthopaedic implants | 9021.31 | 0% | 5% |
| Diagnostic reagents | 3822 | 0–5% | 12% |
| PPE (gloves, masks) | 4015, 6307.90 | 0–10% | 5–12% |
Bill of Entry Checklist for Medical Devices
- CDSCO registration certificate or import license number on BoE
- Device class (A/B/C/D) confirmed
- Manufacturer's CE, FDA, or equivalent approval documentation
- Sterility certificates for sterile devices
- Shelf life / expiry date on invoice
- Lot/batch number for traceability
- Declaration of conformity (MDR 2017)
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Frequently asked questions
CDSCO registration under MDR 2017 for Class B, C, and D devices. Class A devices may self-certify. CDSCO registration number must appear on the bill of entry.
Most medical devices (HS Chapter 90): BCD 0% with IGST 5% (life-saving) or 12% (others). Effective import duty is primarily the IGST component since BCD is 0% for most devices.