India → Russia · sector
Exporting Indian surgical instruments and medical devices to Russia
Indian surgical instruments and disposables are competitive internationally. Medical devices are a registration trade, and the registration path is determined by the device’s risk class before anything commercial can be discussed.
What this trade actually requires
Device registration
Medical devices require registration before they may be marketed. The risk classification determines the evidence burden and the timeline.
Technical file quality
Applications fail on incomplete technical documentation far more often than on the device itself. The file has to be right before filing.
Local representative
A registered local presence is generally required to hold the registration and deal with the regulator.
How we run it
- 01Determine risk classification and the applicable registration route
- 02Technical file review and gap analysis
- 03Translation and dossier preparation
- 04Local representative appointment and filing
- 05Distributor search in parallel
- 06Launch, labelling and first shipment
Common questions
+–How long does device registration take?
It varies substantially by risk class and dossier quality. We assess your technical file first and give a realistic timeline, because an incomplete file is the usual cause of delay.
+–Can we appoint you as the local representative?
We can hold representative positions on the Indian side. For the Russian side our principal advises on the appropriate structure.
+–Should we register before finding a distributor?
Run both in parallel. Distributors take you more seriously once registration is filed, and waiting for approval before starting the channel search wastes a year.