Medical devices are used vastly used in the healthcare pharmaceutical industry throughout the world. It has become the integral part of modern medical industry. The dependency on the medical device has increased handsomely in treatment of any diseases. This dependency has led to quality issues in medical care. By using medical devices for the treatment of diseases has improved the patient's health, but sometimes they also complicate the condition of the patients, as the body does not accept them and consider them as a foreign body. Therefore, for the manufacturing of medical devices, safety and quality are given prime importance in its regulation. The regulations are different in different countries at present. The medical device regulation of the US, European region, China, Japan, is more stringent and advanced. In India, the Government has come out with medical device regulation in 2017 for manufacturing companies. These are regularly updated based on the western world. But still, Indian regulation is not stringent as some of the medical devices are still notified as drugs to cap price regulation. This paper studies the current scenario in India with other foreign countries regarding the regulations of medical devices. It concludes that we cannot accept any medical device as it is accepted elsewhere. The acceptance must be from the Indian Government; trials must be conducted in India and must be notified and made public for any damages, recalled action. This will help our local manufacturers compete other manufacturers worldwide, create more jobs and economic growth based on the Make in India concept.
Key words: Central Drug Standards Control Organization (CDSCO); European Union (EU); Food and Drug Administration (FDA); Medical Device Directive (MDD); Medical devices; World Health Organization (WHO)
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