The India–EU FTA: what changes for European medtech exporters, and what doesn’t

The India–EU free trade agreement will remove most Indian import duties on medical and surgical equipment. It will not remove the need to register. Manufacturers who treat these as one event risk losing the first years of duty-free access.

Where the agreement stands

Negotiations concluded on 27 January 2026. The European Commission sent its proposals to the Council on 11 September 2026. Signing is expected by the end of 2026, and entry into force is expected in 2027.¹

Dates can move during ratification. Treat them as expectations, not deadlines.

What changes: duties

Indian import duties on medical and surgical equipment are up to 27.5% today. Under the agreement, they will be eliminated on about 90% of tariff lines, in phases.¹ Three practical points follow.

• Check your tariff codes. Phasing depends on the tariff line. Your customs classification decides when your products benefit.
• Model landed cost year by year. A phased cut gives a different price path from a single cut. Model your transfer price and the end price in tenders.
• Check rules of origin. Preferential duty requires proof that goods are of EU origin under the agreement. Check early if parts of your product are made outside the EU.

The agreement covers goods of EU origin. Swiss, Norwegian, Icelandic, Liechtenstein and UK manufacturers trade with India under separate arrangements. Check which one applies to you.

What does not change

• Registration. Every device or IVD still needs CDSCO approval through an Indian Authorised Agent: a Form MD-14 application, then a Form MD-15 import licence.² The FTA does not shorten this.
• IVD performance evaluation. For notified IVD categories, evaluation at a CDSCO-designated laboratory still applies. CDSCO last updated its list of these laboratories on 29 June 2026.³
• Price regulation. NPPA ceiling prices apply to notified devices. A lower duty does not lift a ceiling.
• Post-market duties. Labelling, vigilance and the retention fee every five years stay the same.²

Why timing matters

Registration takes months. A manufacturer that starts only when the agreement enters into force will lose part of the duty advantage while it waits for a licence. A manufacturer that files now can have its licence in place when the first tariff cuts apply.

There is a second reason to move early. An unregistered product cannot be quoted in a tender, however low its landed cost. Registration is what turns the duty cut into sales.

A short plan for the next six months

1. Confirm the risk class, and for IVDs the notification status, of each product.
2. Map tariff codes and the expected duty phasing.
3. Assemble the dossier: Device Master File, Plant Master File, CE certificate and free sale certificate.
4. Appoint an Authorised Agent and file the application.
5. Identify three to five anchor accounts for launch.

We can run steps one and two with you as a fit assessment, in two to three weeks.