Medical Devices - Awareness Among the Physicians and Regulatory Concerns in India

Abstract: Medical devices need to be controlled before made available in the market and manufacturers have to ensure that the devices marketed by them are safe and fit for the intended purposes. Apart from manufacturers the users, medical professionals, who use medical devices need to check the quality and safety before medical devices are used by them and should always be alert to report any discrepancy to the manufacturer. A survey was carried out to know the awareness level of physicians regarding the medical devices. It was found in the survey that cost is one of the important factors but are willing to ignore the cost as a factor if medical devices passes through regulatory process and safety of the device is ensured. It was also found that several physicians were not aware about the regulations imposed for medical devices and physicians in big hospitals are not aware of the cost of medical devices and depend on biomedical department for the procurement of medical devices. It was also found that for poorer patients sometimes unapproved cheaper versions of medical devices are used considering high cost of approved medical devices.

Overview: The term medical devices covers a vast range of equipment, from simple tongue depressors to haemodialysis machines. 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 hospital1. With the advent of the technological advances in healthcare significantly more number of medical devices may be reaching the market. As more medical devices are used for various diagnostic and treatment purposes it is required that these medical devices are properly regulated and safety measures are tested before they are approved for marketing. Medical devices could be harmful if it is not regulated and stringently checked. The import and sale of medical devices in India is regulated by the Central Drugs Standard Control Organization (CDSCO), in UK MHRA (Medicines and Healthcare Products Regulatory Agency) governs the regulations on medical devices whereas in the United States it is regulated by Centre for Devices and Radiological Health (CDRH), a division of USFDA (United States Food and Drug Administration).

PHARMA REVIEW - ARTICLES ARCHIVE ( COMPLETE LIST)

The above content is an abstract only. For the full Article please contact:
KONGPOSH Publications Pvt. Ltd.
ICS House, C-19, Commercial Complex, SDA, Opp. IIT Gate, New Delhi, India -110016
Tel.: 26855839, 20057149, Fax: 91-11-26855876
Email: info@kppub.com / fpc@vsnl.com, Website: http://www.kppub.com