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India Medical Device Industry Seeks Global Guidelines

This article was originally published in PharmAsia News

Executive Summary

Indian medical device makers are pressing the Ministry of Health and Family Welfare to lead an effort for international regulatory guidelines and audits. The Association of Indian Medical Devices Industry said the guidelines are needed because some devices are still controlled by India's Drugs Act and treated in roughly the same way as drugs. The group said the industry should be treated separately from pharmaceuticals and the rules and regulations governing them. It noted that catheters, orthopedic implants and stents are among devices regulated under the Drugs and Cosmetics Act. As a result, the industry faces problems with its device exports in some countries. (Click here for more
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