There are 17,000 medical device manufacturers and 511,000 operating companies nationwide. There are 17,000 medical device manufacturers and 511,000 operating companies nationwide.
Recently, the official website of the State Drug Administration released the "2018 Annual Report on Drug Supervision Statistics", which classified and counted the current production and operation, complaints and reports, and case investigations in the fields of drugs, medical devices, and health products in my country.
Combining this regulatory report with the data from 2017, there are relevant contents about medical devices, and the following statistics and comparisons are made.
The 2018 data reporting period is: December 1, 2017 to November 30, 2018
The 2017 data reporting period is: December 1, 2016 to November 30, 2017
Production license situation
As of the end of November 2018, there were 17,000 medical device manufacturers in the country, an increase of about 1,000 from last year. According to production classification:
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7513 enterprises that can produce Class I products |
1417 more than the same period last year |
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9189 enterprises that can produce Class II products |
151 fewer than the same period last year |
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1,997 companies can produce Class III products |
192 fewer companies year-on-year |
It can be seen that the number of companies producing Class I products has grown the fastest. The number of companies producing Class II and Class III products has a decreasing trend.
Business license situation
As of the end of November 2018, there were 511,000 Class II and Class III medical device companies nationwide, an increase of about 100,000 from last year. Specifically:
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There are 292,000 companies that only operate Class II medical devices |
An increase of 67,000 companies year-on-year |
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There are 67,000 companies that only operate Class III medical devices |
An increase of 6,000 companies year-on-year |
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152,000 companies operate both Class II and Class III medical devices |
An increase of 28,000 companies year-on-year |
Judging from the data, the number of domestic medical device companies of all types has increased compared with 2017 in terms of business licenses.
Medical device registration
According to the 2018 data, a total of 22,167 domestic Class I medical devices were registered nationwide, and 1,885 imported Class I medical devices (including Hong Kong, Macao and Taiwan) were registered (these two items were not disclosed in the 2017 annual report, and there is no comparable data for the time being).
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4402 first-time registrations of Class II medical devices in China |
1591 fewer than the same period last year |
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668 first-time registrations of Class III medical devices in China |
199 fewer than the same period last year |
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358 first-time registrations of Class II medical devices imported (including Hong Kong, Macao and Taiwan) |
31 fewer than the same period last year |
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235 first-time registrations of Class III medical devices imported (including Hong Kong, Macao and Taiwan) |
46 more than the same period last year |
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3,364 domestic Class II medical devices were renewed |
3,775 fewer than the same period last year |
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505 domestic Class III medical devices were renewed for registration |
1,111 fewer than the same period last year |
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781 imported (including Hong Kong, Macao and Taiwan) Class II medical devices were renewed for registration |
874 fewer than the same period last year |
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723 imported (including Hong Kong, Macao and Taiwan) Class III medical devices were renewed for registration |
908 fewer than the same period last year |
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3037 changes in domestic Class II medical device licensing items |
A decrease of 1547 items year-on-year |
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526 changes in domestic Class III medical device licensing items |
An increase of 37 items year-on-year |
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860 changes in imported (including Hong Kong, Macao and Taiwan) Class II medical device licensing items |
An increase of 305 items year-on-year |
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862 changes in imported (including Hong Kong, Macao and Taiwan) Class III medical device licensing items |
An increase of 271 cases year-on-year |
It should be noted that during the reporting period, the data of many categories in the medical device registration situation decreased compared with 2017, and some items increased slightly.
Complaints and reports
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18,000 medical device complaints and reports received |
3,000 more than the same period last year |
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1,026 cases filed |
An increase of 192 cases year-on-year |
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1,087 cases closed |
An increase of 259 cases year-on-year |
Whether it is complaints and reports, or case filing and closing, there is a lot more than in 2017.
Case investigation and handling
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18,000 medical device cases |
1,000 more cases year-on-year |
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210 million yuan in goods value |
30 million yuan more year-on-year |
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570 million yuan in fines |
140 million yuan more year-on-year |
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Confiscated illegal income of 17.267 million yuan |
A decrease of 2.424 million yuan year-on-year |
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188 unlicensed businesses were closed down |
An increase of 27 businesses year-on-year |
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Destroyed 6 counterfeiting and selling dens |
