Abstract
Biomedical Metrology group of CSIR-NPL (Council of Scientific and Industrial Research—National Physical Laboratory), India is contributing significantly for establishing National Biomedical equipment standardswhich are traceable to primary standards to cater the quality control regulation in Health sector. This initiative has great impact on the health policy and Nation's economy as well. The laboratory has recently established biomedical equipment standard facility and disseminated the services to Industries, stake holders, hospitals and accredited laboratories. Although, the laboratory is successfully providing biomedical equipment calibration services for last 2 years, the sensitization of the information on the recently established metrological capabilities is required, which has great implications in implementation of India's New medical Device rule 2017 effectively. The present paper describes the summary on the significant achievements and role of National Physical Laboratory in supporting the Indian medical device regulations.
Highlights
Ministry of Health and Family welfare of Government of India has published “New Medical Device and in vitro diagnostic regulations in 2017” and as per the new regulations, ministry’s undertaken organization, central drugs standard control organization has issued medical device rule 2017 and are being implemented in India with effect from January 1, 20181 Medical device regulations accentuate the major requirement of quality control and periodic calibration checks of medical equipment to minimize the medical device errors
Regular calibration of the biomedical equipment to assure the accurate and precise measurements which are traceable to national standards is very crucial in implementing National Quality health infrastructure in Health sector
CSIR-NPL, Indian National Metrological Institute is serving the country by providing calibration facilities traceable to National standards to support the quality regulation of Medical equipment
Summary
Ministry of Health and Family welfare of Government of India has published “New Medical Device and in vitro diagnostic regulations in 2017” and as per the new regulations, ministry’s undertaken organization, central drugs standard control organization has issued medical device rule 2017 and are being implemented in India with effect from January 1, 20181 Medical device regulations accentuate the major requirement of quality control and periodic calibration checks of medical equipment to minimize the medical device errors. In the medical equipment market, the quality control is very important for the correct diagnosis and correct treatment of the patients. Un-calibrated medical devices lead to critical errors in equipment leading to wrong diagnosis, medical device failures causing causality and deaths. Regular calibration of the biomedical equipment to assure the accurate and precise measurements which are traceable to national standards is very crucial in implementing National Quality health infrastructure in Health sector. In this context, CSIR-NPL, Indian National Metrological Institute is serving the country by providing calibration facilities traceable to National standards to support the quality regulation of Medical equipment
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