• Ms.SWETA M.MAHLA
• Ms.GRISHMA DESAI
• DR.RONAK DEDANIA
• DR.VINEET C. JAIN

Abstract: A medical device is any apparatus, appliance, software, material, or other article for the purpose of diagnosis, prevention, monitoring, treatment, or alleviation of disease. The global medical device market reached roughly $209 billion in 2006. The United States (U.S.) regulates medical devices using a classification system based on the risk to the patient from using the device. Medical devices are classified into Class I (least risk), II, and III (most risk). Regulatory control increases from Class I to Class III. Japanese healthcare standards are amongst highest in the world and medical device market is largest in the globe. Japan’s pharmaceutical and medical device agency (PMDA) is the regulatory body responsible for reviewing medical device application. The PMDA works under Ministry of Health, labor, and Welfare (MHLW) to assess new product safety, develop comprehensive regulations and minority post-market safety. Japan medical device regulations are lead down under pharmaceutical and medical device (PMD) act. Health Canada reviews medical devices to assess their safety, effectiveness and quality before being authorized for sale in Canada. The quality management system is evaluated under the Medical Device Single Audit Program (MDSAP) from Jan 1st, 2019.

Regulatory requirement, Medical devices, Registration, Comparison, USA, JAPAN, CANADA

"A Comparative Study of Regulatory Requirements and Guidelines for Medical Devices In USA, Japan And Canada", International Journal of Emerging Technologies and Innovative Research (www.jetir.org), ISSN:2349-5162, Vol.6, Issue 6, page no.613-616, June-2019, Available :http://www.jetir.org/papers/JETIR1906E42.pdf

"A Comparative Study of Regulatory Requirements and Guidelines for Medical Devices In USA, Japan And Canada", International Journal of Emerging Technologies and Innovative Research (www.jetir.org | UGC and issn Approved), ISSN:2349-5162, Vol.6, Issue 6, page no. pp613-616, June-2019, Available at : http://www.jetir.org/papers/JETIR1906E42.pdf