Paper Title

APPROVAL, MANUFACTURING AND MARKETING OF MEDICAL DEVICES INDIA - A STUDY

Abstract

prevent the diseases within the body and/or on the body. A medical device is in the form of instrument, apparatus, and implant or in-vitro devices. In this thesis, we cover the approval, manufacturing and marketing of medical devices in regulated markets like United States, Europe and India in regulatory perspective. We are discussing about Medical device regulatory requirements, classification and approval process in their countries. The Medical devices are more important in the health industry. Now a days, the medical devices are widely used for diagnosis and prevention or to treat public health. These devices are various types based on usage or purpose of the treatment. More than 8000 generic medical device groups are available in the market. Some medical instruments are inbuilt with medicines or drugs.
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Paper Title

GUIDLINES ON COMMON SUBMISSION FORMAT FOR MANUFACTURING OF MEDICAL DEVICES UNDER CLAA SCHEME

Abstract

In India import, manufacture sale and distribution of Medical devices is regulated below medicine and Cosmetics Act, 1940; and Rules, 1945. now following notified Medical Devices are regulated below the aforesaid Act. Manufacture available of Disposable Syringes, Hypodermic Needles, intromission sets and In-vitro Devices are regulated by the involved State Drug Licensing Authority solely. The projected needs for the regulative management over notified medical devices (Under CLAA Scheme) are being uploaded for the knowledge of all stakeholders.
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