The CDSCO heavily relies on GHTF standards, opening a massive fast-track for CE Marked devices. Conversely, India's vast clinical ecosystem offers powerful OUS data for Europe. Eclevar's India Corridor maximises your clinical evidence value, accelerating entry into one of the world's fastest-growing MedTech markets.
Central Drugs Standard Control Organisation
European Medical Device Regulation
With the full implementation of the Medical Device Rules (MDR 2017), the Indian CDSCO has aligned its framework with GHTF/IMDRF guidelines. This creates a massive opportunity: high-risk devices with a valid CE Mark can often waive the requirement for local Indian clinical investigations, accelerating market access by years.
The regulatory bridge between the EU and India is highly synergistic. An EU manufacturer can use its existing Clinical Evaluation Report (CER) and CE Mark to secure a CDSCO Import License (MD-15) rapidly. Conversely, India offers access to a massive, diverse patient population; running an ISO 14155-compliant clinical investigation in India provides high-quality, high-enrolling data that EU Notified Bodies accept for CE Mark submissions. The secret is knowing how to structure the regulatory dossiers for both authorities simultaneously.
With the full implementation of the Medical Device Rules (MDR 2017), the Indian CDSCO has aligned its framework with GHTF/IMDRF guidelines. This creates a massive opportunity: high-risk devices with a valid CE Mark can often waive the requirement for local Indian clinical investigations, accelerating market access by years.
The regulatory bridge between the EU and India is highly synergistic. An EU manufacturer can use its existing Clinical Evaluation Report (CER) and CE Mark to secure a CDSCO Import License (MD-15) rapidly. Conversely, India offers access to a massive, diverse patient population; running an ISO 14155-compliant clinical investigation in India provides high-quality data that EU Notified Bodies accept for CE Mark submissions. The secret is knowing how to structure the regulatory dossiers for both authorities simultaneously.
Eclevar operates the India Corridor bidirectionally. We leverage the immense recruitment potential of India for EU CE Marks, and we fast-track CE Marked devices into the Indian market.
India offers a massive, highly skilled clinical infrastructure. Conducting your clinical investigation or PMCF study in India allows for rapid patient enrollment. We ensure the data collected strictly adheres to EU MDR requirements.
Clinical trials registered in India (CTRI) conducted under ISO 14155 / GCP standards yield high-quality prospective data. We build the bridging analysis to ensure Notified Bodies accept this as primary evidence for EU MDR Annex XIV.
For devices already on the market, large-scale Indian hospital data can serve as robust Post-Market Clinical Follow-up (PMCF) evidence, formatted specifically for your EU Clinical Evaluation Report.
European manufacturers holding a valid CE Mark under EU MDR have a massive advantage in India. We utilize your European regulatory dossier to secure CDSCO Import Licenses (MD-15) and manufacturing approvals (MD-9).
Under the Medical Device Rules (2017), devices approved in GHTF countries (like the EU) can apply for a waiver of local Indian clinical trials. We prepare the clinical justification using your EU CER to secure this waiver.
We convert your EU Technical File and Free Sale Certificate (FSC) into the specific format required by the CDSCO's SUGAM portal, managing all interactions with the Indian regulatory authorities through our local team.
Foreign manufacturers must appoint a local Indian Authorized Agent to hold the license. Our Eclevar India hub provides seamless, compliant, and transparent IAA services to represent your company legally before the CDSCO.
A strategic mapping of primary evidence and administrative requirements.
| Requirement | 🇮🇳 CDSCO India | 🇪🇺 EU MDR | Bridgeability |
|---|---|---|---|
| Prospective Clinical Trial | Required for investigational devices, but waiver available if approved in EU/GHTF. | ISO 14155:2020. EU accepts Indian clinical data if methodology and population bridge safely. | High Overlap |
| Quality Management System | IS/ISO 13485 (Indian Standard). Closely mimics international ISO 13485. | ISO 13485:2016 certified QMS. | High Overlap |
| Device Testing | May require testing in CDSCO-approved laboratories (e.g., BIS standards) for certain classes. | CE testing standards generally accepted, but specific local Indian testing might be mandated. | Gap — Local Testing |
| Local Representation | Indian Authorized Agent (IAA) holding a valid wholesale license (Form 20B/21B). | European Authorized Representative (EC REP). | Gap — Distinct Entities |
| Submission Portal | SUGAM online portal (Centralized registration). | EUDAMED / National Competent Authorities. | Gap — Distinct Systems |
While the clinical data philosophy between the EU and India is closely aligned (thanks to GHTF standards), the biggest hurdle for EU manufacturers is administrative. You cannot register a device in India without an Indian Authorized Agent (IAA), and some specific devices may still require testing in CDSCO-approved local laboratories regardless of CE Mark status. Eclevar resolves this by acting as your transparent IAA through our Pune headquarters and managing all local testing logistics.
A structured model to access the Indian market or leverage Indian data for Europe.
We design the clinical investigation or PMCF study to be conducted in India, ensuring the protocol strictly adheres to ISO 14155 and EU MDR Annex XV.
Our Pune-based clinical operations team manages rapid patient enrollment, monitoring, and data management via MILO EDC across top-tier Indian clinical sites.
We author the EU CER, incorporating the Indian clinical data and providing the required demographic bridging analysis for the Notified Body.
We evaluate your CE Mark certificate, EU Technical File, and Free Sale Certificate (FSC) to prepare the waiver for local Indian clinical investigation.
Eclevar acts as your official IAA, preparing the necessary legal agreements and wholesale licenses required for registration.
We format your EU dossier into the CDSCO requirements and submit the application for the Import License (MD-15) via the SUGAM portal.
We manage CDSCO queries until the license is granted, enabling you to legally export and sell your device in India.
Real programs, driving rapid access and robust data generation.
A European manufacturer of spinal implants wanted to enter the booming Indian market. Rather than executing a costly local trial, Eclevar used their EU CE Mark and Free Sale Certificate to secure a clinical investigation waiver from the CDSCO. Eclevar acted as the Indian Authorized Agent, securing the MD-15 import license in under 4 months.
Facing a massive PMCF data gap for EU MDR, a wound care company utilized Eclevar's India clinical network. We enrolled 300 patients across 4 Indian hospitals in record time using MILO EDC. The trial was ISO 14155 compliant, and the data was successfully accepted by the EU Notified Body to maintain the CE Mark.
"We were daunted by the CDSCO regulations and the need for an Indian agent. Eclevar handled everything seamlessly from their Pune office. They leveraged our CE Mark perfectly, waiving the local trial and getting us to market much faster than expected."
"The speed of clinical enrollment in India is unmatched, but ensuring the data meets EU Notified Body standards is the real challenge. Eclevar managed the trial flawlessly, and their bridging argument in the CER was accepted without a single Major NCR."
