Regulatory guide
How a device or IVD made outside India is approved for import
An Indian Authorised Agent files with CDSCO and holds the import licence. This page explains the route in plain English.
Explanatory, not legal advice. As of October 2026.
The CDSCO pathway
Seven steps, from appointment to vigilance
- Appointment
Manufacturer appoints an Authorised Agent
A written appointment of an Indian company.
- Licence
Agent holds a wholesale licence
Required before the agent can import and sell.1
- MD-14
Agent files the import application
On the CDSCO online portal, with the dossier.
- Review
CDSCO review and queries
May include IVD performance evaluation.
- MD-15
CDSCO grants the import licence
Issued to the agent, for the listed products.
- Market
Import and sale
Customs clearance, storage, supply to customers.
- Post-market
Vigilance and retention
Adverse-event reporting; retention fee every five years.
Risk classes
India classifies devices from A (low risk) to D (high risk)
Classification is product-specific. CDSCO publishes classification lists by category. Examples below are generic and illustrative.
| Class | Risk | Generic examples | Import route |
|---|---|---|---|
| A | Low | Tongue depressors, non-sterile examination items | Non-sterile, non-measuring Class A devices are exempt from the MD-15 import licence; portal registration still applies.2 Others: MD-14 → MD-15. |
| B | Low to moderate | Hypodermic needles, suction equipment | MD-14 → MD-15, granted by CDSCO |
| C | Moderate to high | Lung ventilators, bone fixation plates | MD-14 → MD-15, granted by CDSCO |
| D | High | Heart valves, implantable defibrillators | MD-14 → MD-15, granted by CDSCO |
IVD specifics
Some IVDs need performance evaluation in India
For notified IVD categories, CDSCO requires performance evaluation at a CDSCO-designated laboratory before it grants the import licence.
CDSCO last updated its list of these laboratories on 29 June 2026.3 Whether your kit needs evaluation, and at which laboratory, is part of our fit assessment.
After approval
Three obligations continue for as long as you sell
Retention fee
The MD-15 licence stays valid subject to a retention fee every five years.1
Materiovigilance
Adverse events and complaints are reported to the Indian authorities. Field safety actions are run in India by the licence holder.
Labelling
Labels must meet the Medical Devices Rules, 2017, including Indian importer details. We check labels before the first shipment.
Trade agreements
For EU manufacturers: the India–EU FTA
- 27 Jan 2026
- Negotiations concluded4
- 11 Sep 2026
- European Commission sent proposals to the Council
- End-2026
- Signing expected
- 2027
- Entry into force expected
What changes
Indian duties of up to 27.5% on medical and surgical equipment will be eliminated on about 90% of tariff lines, in phases.4 Timing depends on each product’s tariff line.
What does not change
- CDSCO registration through an Authorised Agent
- IVD performance evaluation for notified categories
- Price regulation by NPPA
- Labelling, vigilance and retention fees
The agreement covers goods of EU origin only. Manufacturers elsewhere should check which trade arrangement, if any, applies to them. Registration requirements are the same for all.
Price regulation
Ceiling prices apply only to notified devices
The National Pharmaceutical Pricing Authority (NPPA) sets ceiling prices for devices notified under price control. Other devices are not subject to a ceiling.
We check the status of each of your products during the fit assessment.
Sources
- Medical Devices Rules, 2017, Central Drugs Standard Control Organisation (CDSCO).
- CDSCO notification on Class A non-sterile, non-measuring devices.
- CDSCO, list of laboratories for performance evaluation of in-vitro diagnostic devices, last updated 29 Jun 2026.
- European Commission, EU–India trade agreement: negotiations concluded 27 Jan 2026; proposals sent to the Council 11 Sep 2026. Duties of up to 27.5% on medical and surgical equipment to be eliminated on about 90% of tariff lines, in phases.