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THE PHARMA REVIEW (NOVEMBER - DECEMBER 2016)

Medical Device Regulation: India on Global Perspective

Dr. Papiya Bigoniya* & Mr. Dharmesh Bigoniya1

Introduction: Indian is one of the fastest growing emerging market of medical devices due to ageing population, growing, medical tourism, lower cost of treatments and better treatment options. India’s high end medical device market is largely dominated by imported products and domestic companies largely manufacture low-end products. Central Drugs Standard Control Organization, Ministry of Health and Family Welfare regulates medical device in India under the provisions of the Drugs and Cosmetics Act 1940 & Rules 1945. The CDSCO has 14 notified medical devices that are required to get manufacturing license, while most of the devices manufactured do not need any approval or license. European Union, WHO and USFDA has well developed medical device regulation given with classification as per risk to patients and depending on the classification the level of control on marketing authorization. International Medical Device Regulators Forum and Asian Harmonization Working Party are also working on regulatory harmonization for development of data regarding safety, performance requirements, quality systems, standards and procedures of post-market surveillance for medical devices. CDSCO is working continuously in the direction of developing and implementing strict regulation drafting Medical Device Rules, 2016 now available on CDSCO website for comments, objections and suggestions of stakeholders. 

 

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