On May 24, May 24, the website of the state administration of pharmaceutical and drug administration (cfda) hung out the annual report on food and drug administration of 2016 (the annual report). 

 

Cypress blue instruments noticed a startling change in data: 

 

As of the end of November 2016, there were 335, 725 companies operating in two or three categories of medical devices nationwide, according to the annual report. 

 

Since 2007, the administration's website has issued an annual annual report on the annual report, which has been issued for 11 years. And in the total number of licensed medical devices that run the business, the figures for the past 11 years are as follows: 

 

 

 

As above, the figures for 2016 are staggering compared with any previous year. Compared with 2015, there are more than 150,000 second and three types of medical device operating enterprises in 2016. 

 

The annual report shows that in 330000 two, three kinds of YiXie operating companies, total only 2 kinds of medical equipment products of 164634 enterprises, only three types of equipment for 62220, at the same time engaged in two, three types of medical equipment management for 108871. 

 

Before 2015, the annual report of the drug administration, the medical device operators were the only ones with the total number of certified enterprises. In 2015, the company began to give out the business data for the second and third types of medical products. In 2016, we will further refine the three categories of these three categories, which are only in the second category, running three types of business, and running two or three categories at the same time. 

 

Statistically, it is more and more detailed and specific. Why, then, did the country suddenly produce more than a dozen or so licensed carers last year? This problem needs further explanation. 

 

In terms of production volume, the report said, by the end of November 2016, 15343 of the medical device production enterprises, of which: 4979 can produce a kind of product enterprises, can produce 2 kinds of products, 8957, 2366 can produce three kinds of products of enterprises. 

 

Here are a few years since 2006: 

 

 

 

The above data show that after the 2015 suddenly reduce, 2016, the actual number of medical device manufacturing enterprise also rebounded, increased nearly more than 1200 machinery companies all the year round. 

 

In addition, the annual report disclosure of the last year of medical apparatus and instruments for examination and approval of registration data, YiXie advertising and investigation data, accept YiXie complaints and the investigation of the case. 

 

The following are details of the data in the annual report: 

 

The production license of medical devices 

 

By the end of November 2016, 15343 of the medical device production enterprises, including: 4979 can produce a kind of product enterprises, 8957 can produce 2 kinds of products of enterprises, it can produce three kinds of products by 2366. 

 

Medical device business license 

 

By the end of November 2016, the national total of two, three types of medical equipment management enterprise 335725, among them, only 164634 class ii medical device products of enterprises, only three types of medical equipment products enterprise, 62220, at the same time engaged in two and three types of medical equipment management enterprise in 108871. 

 

Registration of medical devices 

 

In 2016, the first category of medical devices in China was approved for the record 11,539 units, and the first category of medical devices for imported medical devices was put on the record 3023. Registered within the territory of the second type of medical apparatus and instruments, 6093, the third class registered within the territory of 929 pieces of medical devices, import the second category of registered medical devices (including Hong Kong, Macao and Taiwan) 444, imports of the third class 593 other registered medical devices (including Hong Kong, Macao and Taiwan). Approval in the second category of registered medical apparatus and instruments, 6076, in the third class registered medical device 1510, import the second last registered medical devices (including Hong Kong, Macao and Taiwan) 2077, imports of third class continue 1634 other registered medical devices (including Hong Kong, Macao and Taiwan). The second category of licensing items in the territory has been changed to 3,814 medical devices, and the third class and import (including Hong Kong, Macao and Taiwan) licensing items in the territory have been changed to 1466 medical devices. 

 

Advertisement examination and approval and examination 

 

In 2016, 7109 medical devices were approved for medical devices, and 575 were transferred to the administrative department for industry and commerce. Cancelling medical device advertising approval number 20. 

 

Complaint reporting 

 

In 2016, the food and drug administration of all levels received 11,693 complaints and 803 cases, 968 cases. 

 

The case is investigated 

 

2016 the food and drug regulators dealt with 13865 cases of medical apparatus and instruments, value 81.28 million yuan, the fines of 243.34 million yuan, confiscate the illegal income amount is 20.724 million yuan, clamp down on unlicensed business 163, destroying the production and sale of counterfeit goods dens 17, order to suspend production or business 170, 15, license of judiciary authority in 67. 

 

Note: [1] was derived from the food and drug administration statistical reporting system. The data report period is December 1, 2015, solstice, November 30, 2016. 

 

[2] medical equipment production license: the production of both products and production of three categories, respectively when statistical meter for a class of production enterprises and three types of production enterprises, the total number of enterprises only a meter. 

 

[3] medical device operating license situation: the second class and three types of enterprises have their respective categories respectively.