On May 9, 2018 Annual Statistic Report on Drug Supervision was issued through the official website of NMPA. It provides the categorical statistics of production, operation, complaints and case investigation etc. in the fields of drugs, medical devices and health care products etc. in China.
Production license
By the end of November 2018, China had 17,000 medical device manufacturers, increasing about 1,000 manufacturers over the previous year. According to the classification of production:
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7,513 enterprises that can produce Class I products |
Increasing 1,417 enterprises over the previous year |
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9,189 enterprises that can produce Class II products |
Decreasing 151 enterprises over the previous year |
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1,997 enterprises that can produce Class III products |
Decreasing 192 enterprises over the previous year |
As is seen, the number of enterprises producing Class I products grows fastest in terms of production license. The number of enterprises producing Class II and III products tends to decrease.
Operation license
By the end of November 2018, there are 511,000 enterprises engaged in Class II and III medical devices in China, increasing about 100,000 over the previous year. The specific situation is as follows:
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292,000 enterprises only engage in Class II medical device products |
Increasing 67,000 enterprises over the previous year |
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67,000 enterprises only engage in Class III medical device products |
Increasing 6,000 enterprises over the previous year |
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152,000 enterprises engage in Class II and Class III medical device products |
Increasing 28,000 enterprises over the previous year |
Registration of medical devices
According to data of 2018, there are 22,167 filed Class I medical devices and 1,885 filed Class I imported medical devices (including those imported from Hong Kong, Macao and Taiwan) in China. Data of the said two items is not disclosed in 2017 report, so no data is available for comparison.
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4,402 Class II medical devices are registered in China for the first time |
Decreasing 1,591 medical devices over the previous year |
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668 Class III medical devices are registered in China for the first time |
Decreasing 199 medical devices over the previous year |
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358 Class II imported medical devices (including those imported from Hong Kong, Macao and Taiwan) are registered for the first time |
Decreasing 31 medical devices over the previous year |
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235 Class II imported medical devices (including those imported from Hong Kong, Macao and Taiwan) are registered for the first time |
Increasing 46 medical devices over the previous year |
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The registration of 3,364 Class II medical devices in China is renewed |
Decreasing 3,775 medical devices over the previous year |
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The registration of 505 Class III medical devices is renewed in China |
Decreasing 1,111 medical devices over the previous year |
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The registration of 781 Class II imported medical devices (including those imported from Hong Kong, Macao and Taiwan) is renewed |
Decreasing 874 medical devices over the previous year |
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The registration of 723 Class III imported medical devices (including those imported from Hong Kong, Macao and Taiwan) is renewed |
Decreasing 908 medical devices over the previous year |
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3,037 licenses of Class II medical devices are changed in China |
Decreasing 1,547 medical devices over the previous year |
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526 licenses of Class III medical devices are changed in China |
Increasing 37 licenses over the previous year |
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860 licenses of Class II imported medical devices (including those imported from Hong Kong, Macao and Taiwan) are changed |
Increasing 305 licenses over the previous year |
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862 licenses of Class III imported medical devices (including those imported from Hong Kong, Macao and Taiwan) are changed |
Increasing 271 licenses over the previous year |
In the report period, the most categories of registered medical devices decrease and a few categories increase in number compared with those in 2017.
Complaints
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18,000 complaints about medical devices are accepted |
Increasing 3,000 complaints over the previous year |
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1,026 complaints about medical devices are filed |
Increasing 192 complaints over the previous year |
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1,087 complaints about medical devices are settled |
Increasing 259 complaints over the previous year |
Complaints and their filing and settlement all increase compared with those in 2017.
Case investigation
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There are 18,000 medical device cases |
Increasing 1,000 cases over the previous year |
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The value of medical devices involved in the cases is CNY 210 million |
Increasing CNY 30 million over the previous year |
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The fine is CNY 570 million |
Increasing CNY 140 million over the previous year |
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The amount of illegal income confiscated is CNY 17.267 million |
Decreasing CNY 2.424 million over the previous year |
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188 unlicensed operators are banned |
Increasing 27 operators over the previous year |
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Six places where counterfeited medical devices are produced and sold are destroyed |
Decreasing 25 counterfeited medical device operators over the previous year |
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89 operators are ordered to stop production or suspend business |
Decreasing 9 operators over the previous year |
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The licenses of 7 operators are revoked |
Decreasing 4 operators over the previous year |
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41 cases are transferred to judicial authorities |
Decreasing 21 cases over the previous year |
According to the data above, the number of medical device cases continues to increase and the fines during case investigation increase by CNY 140 million. 188 unlicensed operators are banned.
Comprehensive rectification in the report period
It can be seen that NMPA has continually strengthened rectification.
It should be noted that NMPA issued the 2018 Special Rectification Plan for Cracking Down on the Illegal Operation and Use of Medical Devices in the report period, and the rectification was carried out nationwide from May to the end of November 2018, which was one of important actions decided at the national medical device regulatory conference that year.
There are five tasks for the special rectification:
(I) The operation and online selling of medical devices without permission and filing shall be strictly checked.
(II) The operation (including online selling) and use of medical devices without registration certificate or filing certificate shall be strictly checked.
(III) Illegal operation of such products as sodium hyaluronate for injection, condoms and contact lenses with high attention and large usage shall be strictly checked.
(IV) The implementation of Quality Management Practices for Medical Device Operation in the enterprises engaged in the Class III medical devices shall be checked.
(V) The implementation of Measures for Supervision and Administration of Use Quality of Medical Devices shall be checked.
Compared with the past, NMPA carried out the special rectification against all medical device operators across China instead of Class II and Class III medical device operators.
However, Class III operators are still the focus. Unannounced inspection and cross check shall be adopted for supervision and check.
Focus on thorough investigation into unlicensed operation
In the report period, the rectification is more targeted than before, focusing on the following two illegal activities: unlicensed operation and operation & use of unlicensed medical devices.
According to the latest 2018 statistical report, 188 unlicensed medical device enterprises have been forced out of the business and Many of 18,000 cases and CNY 57 million fines were related to unlicensed medical devices.
It is reported that the parties involved in the administrative punishment cases for unlicensed medical devices include individuals, small distributors, large multinational enterprises, domestic leading listed enterprises and many medical institutions at all levels across China.
Besides, Measures for the Supervision and Administration of Online Sales of Medical Devices was implemented in the report period. It is clearly specified in the Measures that enterprises and third-party platforms engaged in online sales of medical devices must have the permits or filing certificates and comply with laws, regulations and rules related to medical devices.
Online and offline implementation has achieved significant results, and the purification and elimination in the medical device industry have made great progress. It also indicates that NMPA will continually strengthen the supervision of illegal activities in the industry.
Source: National Medical Products Administration
Complied by: Medchina