Another 177 disappeared | The number of such weapons companies in the country has fallen back 10 years ago

Medical Network April 3 hearing Yesterday, the State Administration of Food and Drugs released the "2017 annual report of food and drug regulatory statistics."

As of the end of November 2017, the country’s actual medical device production enterprise 16,000. Among them: There are 6,096 companies that can produce a class of products, 9340 companies that can produce a second class of products, and 2189 that can produce three types of products.

The data shows that in the past year, about 5,000 additional machinery companies have come out of the country.

Since 2007, the total number of actual medical device manufacturers in China has been steadily increasing over the years. The growth rate is about 3%. The only exception is in 2015. This year, the country's national military equipment prices have dropped by 2,000.

After a sharp fall in 2015 and a return to growth in 2016, the total number of actual machinery companies in the country returned to its 2014 peak level in 2017.

However, it is worth noting that the growth in the number of national machinery companies mainly comes from the low-risk category I medical device manufacturers, while the number of high-risk category III medical device manufacturers continues to decrease.

In the past year, the number of high-risk third-class machinery enterprises has decreased by 177, and the number has fallen back to the level of a decade ago.

At the same time, the "Statistical Annual Report" stated that as of the end of November 2017, there were 41,000 medical equipment manufacturers operating in the second and third categories in the country. Among them, there were 225,000 enterprises that operated only the second category of medical device products and operated only three types of medical services. There are 61,000 enterprises engaged in equipment products and 124,000 companies engaged in the second and third categories of medical devices.

The data shows that in the past year, there were an additional 78,000 dealers nationwide.

The total number of actual machinery dealers in the country has increased rapidly since 2017 and reached a new peak level in 2017.

However, it is noteworthy that the growth in the number of national machinery dealers mainly comes from companies that operate second-class medical device products, while the machinery operators that operated only three types of products were reduced from 62,220 to 61,000 last year.

The reduction in the number of companies associated with the third category of medical devices may be related to the key rectification of the third category of high-risk products by the drug administration.

Medical equipment GMP Standards, the third type of firearms companies first landed, and took the lead in accepting medical GMP flight inspections and other work. Remediation has brought about the purification of the industry, and some non-compliant companies have actively or passively phased out the game.

Previously, the State Food and Drug Administration had made it clear that in 2018, Class I and Class II machinery companies must also meet deadlines for GMP compliance, and will initiate timely inspections for these two types of machinery. This will take The elimination of some Class I and Class II machinery enterprises.

The following are the changes in the number of Chinese medical device manufacturers during 2007~2017:

The "Annual Report" also disclosed the status of the registration of medical devices in the country and the status of the drug monitoring and investigating cases.

In 2017, a total of 5993 medical devices were approved for registration in the country for the second category, and 8,67 for the third category of medical devices registered in the country. For the first time, 389 imported category II medical devices were imported (including Hong Kong, Macao, and Taiwan), and imported (including Hong Kong, Macau, and Taiwan). The first type of medical device of the third type registered 189 cases. Approved 7923 consecutive registrations of the second category of medical devices in China, 1,616 consecutive types of the third type of medical devices registered in the territory, and imported (including Hong Kong, Macao and Taiwan) the second type of medical devices continued to register 1,655 pieces of imports. (Including Hong Kong, Macao, and Taiwan) The third category of medical devices continued to register for 1,631 items. The second category of medical device licensing items changed, 4584, and the third category of medical device permits changed 489 pieces. Imported (including Hong Kong, Macao and Taiwan) Type II Medical Devices 555 license items were changed. Imports (including Hong Kong, Macao, and Taiwan) changed 591 license items for Category III medical devices.

2017 food drug Supervision Department medical instruments The number of cases was 17,000, the value of goods was 180 million yuan, the amount of fines was 430 million yuan, the amount of illegal proceeds confiscated was 1969.10 yuan, 161 unlicensed businesses were banned, 31 counterfeit counterfeit dens were dismantled, and 98 businesses were ordered to suspend production or business operations, and licenses were revoked. 13 warrants were handed over to the judicial authorities.