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Abstract

PRECISE AND COMPARATIVE REQUIREMENTS OF ACTIVE IMPLANTABLE MEDICAL DEVICE IN US, AUSTRALIA AND SINGAPORE

Vishal H. Parikh, Krupa C. Thula*, Dilip G. Maheshwari

Medical device market has been improving its impact globally and it is the widely growing field now a days. The Cardiovascular Device industry is rapidly expanding its impact in the market and it will reach to $97 billion by end of 2015. Worldwide many people suffering from cardiovascular diseases and number of deaths has been reported every year. So, to improve the patient life and reduce the morbidity and mortality rate the strict rules and regulation has to be developed. Cardiovascular devices are life threatening devices and it is directly affecting the patient’s life so strict and specific regulation is requiring for active implantable medical devices. In US, Food and Drug Administration high-risk medical device registered via the Pre-Market Approval process. In Australia, Therapeutic Goods Administration regulates the medical device under the Australian Register of Therapeutic Goods. In Singapore, Health Science Authority regulates the medical device under the Centre for Medical Device Registration. This article discuss about the general introduction about medical device, its classification, registration procedure, labeling requirements for active implantable medical device in US, Australia and Singapore.


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Citations : 938

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