Abstract

COMPARISION OF MEDICAL DEVICES REGULATIONS IN INDIA EUROPE AND AUSTRALIA

Vemuliah Challagiri*, M. V. Nagabhushanam, P. V. Siva Krishna, Brahmaiah Bonthagarala and G. Ramakrishna

ABSTRACT

Medical devices are serving an increasing role in improving patient s health and quality of life and in clinical practice. All three countries follow the GHTF regulations for medical devices but all have their own guidelines. All the three countries have different regulatory approval process for registration of medical device. By comparing all the parameters it has been seen that Europe and Australia has more stringent regulations as compared to India and according to the application fees Australian registration fees are most costly as compared to all the three countries. . Like medicines and other health technologies, they are essential for patient care at the bedside, at the rural health clinic or at the large, specialized hospital. Surprisingly, regulatory controls for medical devices are scarce in the developing world, even though implementation of national medical device regulations will often address the very issues raised in countries as major concerns for patient safety. As an important input to the health care system, medical devices should be properly managed and utilized in order to produce an efficient health intervention.

Keywords: Medical devices, India, Europe and Australia.