Mon, 18 Dec 2017

Regulation and Registration Requirements of Medical Device and its Comparison in Australia and India

Krupa Chaitanyakumar Thula1*, Pooja Brijeshkumar Patel2, Dilip Girishbhai Maheshwari3

1.  Department of Quality Assurance and Pharm Regulatory Affairs, L. J Institute of Pharmacy, Sarkhej, Ahmedabad – 382210, Gujarat, India.

2. Department of Quality Assurance and Pharm Regulatory Affairs, L. J Institute of Pharmacy, Sarkhej, Ahmedabad – 382210, Gujarat, India.

3. Head of Department of Quality Assurance and Pharm Regulatory Affairs, L. J Institute of Pharmacy, Sarkhej, Ahmedabad – 382210, Gujarat, India.


ABSTRACT

Medical devices have been become more important in the health care sector. It is mostly used for diagnosis and prevention of public health. There are more than 8000 generic medical device groups, where some medical devices contain drugs. This increases the demand for better regulatory frameworks to ensure that products entering in the market are safe as well as efficient. One of the major issues for companies developing and producing medical devices is to be updated on the bases of regulatory requirements and to implement them in the process. This is particularly true in developing countries, where assessments of health technology are rare and where little regulatory controls exist to prevent the importation or use of substandard devices. So regulation of medical device is a vital need in Pharmaceutical Sector. This article mainly focuses on classification, classification rules, registration procedure, documents required for registration of medical device and fees for application of medical devices in Australia and India. In Australia medical devices are regulated by Therapeutics Good Administration (TGA) whereas in India medical devices are regulated by Central Drugs Standard Control Organization (CDSCO).

Keywords: Medical device, Regulation, Classification rules, Australia, India, CDSCO, TGA, ARGMD.


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