Does a CDSCO licence allow a device to be sold in the EU?
No. The Indian classes A to D do not map one to one onto the EU classes, and the EU route requires notified body involvement, an authorised representative, EUDAMED registration and clinical evidence that stands without leaning on equivalence.
What has to be done
- Classify the device and identify the conformity assessment route; only class I non-sterile, non-measuring devices avoid a notified body.
- Appoint an EU authorised representative under Article 11 and keep the written mandate available; this is a device-specific role, not the GPSR one.
- Operate a quality management system to ISO 13485 and a post-market surveillance system with periodic safety update reporting.
Citations
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Source and version
- Read date
- 2026-08-26
- Address
- /in/questions/cdsco-versus-mdr
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