dimarts, 10 de febrer del 2015

Indian regulators consider pre-submission consulting for medical device registrants




The Emergo Group Blog provides short updates on quality and regulatory topics that may be of interest to QA/RA professionals in the medical device and IVD industry. No fluff, just straight to the point. We hope you'll enjoy the content.





Emergo Group

By Stewart Eisenhart, Emergo Group


India's Central Drugs Standard Control Organization (CDSCO) is seeking comment on a new proposal to establish formal pre-submission consultations with firms seeking medical device registration in the country. The consultations would apply to devices as well as drugs and clinical trials.




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