Production and operation enterprise
Statistics show that since 2007, China's medical device manufacturers have been growing steadily in Class I, Class II or Class III. The total amount has increased from 12,600 in the past 8 years to more than 16,000 in 2014. Basically maintained at a level of about 3%.
Among them, the number of Class III medical device manufacturing enterprises in China has remained at a certain level in addition to the previous year, except for the previous year. Despite the stricter approval and punishment of high-risk medical devices since 2014, China's Class III medical device manufacturers are still growing.
In terms of operating companies, operating companies holding medical device licenses have grown slowly over the past eight years, from 160,100 in 2007 to 188,800 in 2014.
Medical device registration
China's registration system for medical devices, the "2014 Annual Report on Food and Drug Regulations" published by the State Food and Drug Administration shows that the number of re-registration of Class I medical devices decreased significantly in 2014, to 1,885, compared with 3,738 in the previous year. Decreased by about 50%;
The number of re-registration of Class II medical devices increased significantly, and the number of Class II re-registrations reached 7,742, an increase of 28.28% from 5,801 in the previous year. The number of re-registered imported medical devices increased, and the number of re-registrations reached 4,839, an increase of 27.41% over the previous year's 3,798.
Statistics show that from 2007 to 2014, the total registration of medical device Class I products in China has basically maintained an upward trend, from 3,452 in 2007 to 6,761 in 2014, an increase of nearly one-fold.
The total number of registered medical devices in Class II medical equipment changed little between 2009 and 2012, and the total number was 7,000 per year. After the first substantial increase in 2013, it continued to grow rapidly in 2014, with a total of 13,158 pieces, which was 3.81 in 2007. Times
After the significant increase in Class III medical device registration in 2012, 2014 declined; the registration of medical devices in Hong Kong, Macao and Taiwan grew slowly;
The first registration and re-registration of imported medical devices, following a substantial increase in 2012, reached a rapid growth in 2014, reaching 9052, an increase of 17.34% compared with 7,714 in 2013. The increase in the number of imported medical device registrations indicates that more foreign companies are optimistic about China's huge medical market, and the future market competition environment will be more intense.
The total market size of medical devices in China in 2014 was about 255.6 billion yuan, but there were 161,000 production enterprises, with an average of 15.88 million yuan each, indicating that the market concentration of medical device production is low, and the products are small, scattered, and low in added value. It is also ubiquitous.
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