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After several years of increase the number of medical device clinical trials has reduced by 20% in Korea.
Food and Drug Safety Division is analyzing the last medical device clinical trial planning approval status, full approval number: 63 cases. It has reduced by 20% compared to the previous year.
The following trend can be observed:
In 2010: 38 cases.
2011: 43 cases.
2012: 76 cases.
2013: 77 cases.
In 2014, 56 cases were medical device clinical trial plan approved for domestic and 7 for foreign manufacturers. Respectively a reduction of 12% and 50%.
The majority of the decrease comes from products like biomaterials such as cosmetic filler for which the market is saturated.
In contrast energy stimulation device (electrical, acoustic or light energy) application have increased from 4 to 10 cases.
Food and Drug Safety Division is analyzing the last medical device clinical trial planning approval status, full approval number: 63 cases. It has reduced by 20% compared to the previous year.
The following trend can be observed:
In 2010: 38 cases.
2011: 43 cases.
2012: 76 cases.
2013: 77 cases.
In 2014, 56 cases were medical device clinical trial plan approved for domestic and 7 for foreign manufacturers. Respectively a reduction of 12% and 50%.
The majority of the decrease comes from products like biomaterials such as cosmetic filler for which the market is saturated.
In contrast energy stimulation device (electrical, acoustic or light energy) application have increased from 4 to 10 cases.
