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.