Regulatory Services

Ethics Committee Approval – CDSCO/ICMR for Medical Devices

Accelerate your clinical investigation approvals with expert Ethics Committee (EC) guidance tailored for medical device compliance in India.

Why Ethics Committee Approval Matters

Before initiating clinical investigations or human trials for medical devices in India, obtaining Ethics Committee (EC) approval is mandatory under the Central Drugs Standard Control Organization (CDSCO) regulations and Indian Council of Medical Research (ICMR) guidelines. This ensures protection of patient rights, safety, and well-being during trials and aligns your study with both national and international ethical standards.

Whether you're a medical device manufacturer, sponsor, or CRO, we ensures your submission is complete, compliant, and ready for EC and CDSCO review.

We offer end-to-end support for obtaining Ethics Committee approval under CDSCO and ICMR frameworks, including:

Feasibility Assessment

  • Identify if your study requires EC and CDSCO approval
  • Determine applicable pathways (e.g., investigational device, observational study)

Documentation & Dossier Preparation

  • Prepare and review clinical investigation plans
  • Draft informed consent forms, investigator brochures, and case report forms
  • Prepare risk-benefit analysis and patient safety protocols

Ethics Committee Identification & Coordination

  • Assistance in selecting a CDSCO-registered EC
  • Coordination with hospital/institutional ECs or independent ECs as per study needs
  • Submission tracking and response to EC queries

CDSCO Submission Support (If Applicable)

  • Guidance on dual submissions (EC + CDSCO) for Class C/D devices
  • Preparation of clinical investigation application under Form MD-22 and approval in Form MD-23

Compliance with ICMR Guidelines

  • Align all submissions with National Ethical Guidelines for Biomedical and Health Research involving Human Participants (ICMR, 2017)
  • Guidance on dual submissions (EC + CDSCO) for Class C/D devices
  • Preparation of clinical investigation application under Form MD-22 and approval in Form MD-23

Who We Serve

Contract Manufacturers & Suppliers

Medical device manufacturers (domestic and foreign)

Medical Device & IVD Manufacturers

Contract Research Organizations (CROs)

Distributors & Importers

Startups and MedTech innovators

EU Authorized Representatives

Academic researchers conducting device-based studies

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