CDSCO relies on GHTF standards, enabling fast-track access for CE-marked devices into India, while India's clinical ecosystem provides robust outside-US data for European submissions.
Platinum Award 2026
Top prize in the xShare x European CRO Federation "EHDS & Clinical Research" Open Call, awarded to Eclevar MedTech and its Milo Health platform, presented at the EUCROF 2026 conference in Amsterdam.
Horizon Europe · Grant Agreement No. 101136734 · Amsterdam, 2 Feb 2026
India's Medical Device Rules (MDR 2017) aligned the CDSCO framework with GHTF and IMDRF guidelines. High-risk CE-marked devices can often waive local Indian clinical investigations, accelerating market access significantly.
Conversely, India provides access to diverse patient populations. ISO 14155-compliant clinical investigations generate high-quality data that EU Notified Bodies accept, run from our Pune headquarters.
India offers clinical infrastructure for rapid patient enrolment. Data must strictly adhere to EU MDR requirements.
EU manufacturers with a valid CE mark gain significant advantages in India.
The clinical data philosophy aligns via GHTF standards. The primary hurdle is administrative: an IAA is mandatory, and certain devices require CDSCO-approved lab testing regardless of CE mark status.
| Requirement | CDSCO India | EU MDR | Bridgeability |
|---|---|---|---|
| Prospective clinical trial | Required for investigational devices; waiver if EU/GHTF approved. | ISO 14155:2026; accepts Indian data if methodology and population bridge safely. | High overlap |
| Quality management system | IS/ISO 13485 (Indian Standard). | ISO 13485:2016 certified QMS. | High overlap |
| Device testing | May require CDSCO-approved lab testing (BIS standards). | CE testing standards generally accepted. | Gap · local testing |
| Local representation | Indian Authorised Agent (IAA) with wholesale licence (Form 20B/21B). | European Authorised Representative (EC REP). | Gap · distinct entities |
| Submission portal | SUGAM online portal (centralised registration). | EUDAMED / National Competent Authorities. | Gap · distinct systems |
A European spinal implant manufacturer entered the Indian market using its CE mark and FSC to secure a clinical investigation waiver. Eclevar acted as IAA, securing the MD-15 import licence in under four months.
A wound-care company closed a PMCF data gap using Eclevar's Indian clinical network, enrolling 300 patients across four hospitals on MILO EDC under ISO 14155. The data was accepted by the EU Notified Body to maintain the CE mark.
No. Devices approved in GHTF countries, such as those with an EU CE mark or US FDA clearance, can apply for local clinical trial waivers.
Yes, if trials adhere to ISO 14155 and the patient population bridges to European standards. Eclevar specialises in the bridging arguments that make Indian data acceptable.
Foreign manufacturers cannot register directly in India. An IAA is a legally appointed entity holding the required wholesale licences and serving as the official CDSCO representative. Eclevar provides this through its Pune hub.
We assess your existing clinical evidence and map the fastest compliant pathway to navigate CDSCO and EU MDR requirements simultaneously.
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