The State Council ordered 27 cities to form an alliance to affect all medical workers!

Source: Cypress blue device / in vitro diagnostic dealer Alliance ▍ editor: Mick 27 cities include Shanghai, Nanjing, Wuxi, Changzhou, Suzhou, Nantong, Yangzhou, Zhenjiang, Yancheng, Taizhou, Hangzhou, Ningbo, Wenzhou, Huzhou, Jiaxing, Shaoxing, Jinhua, Zhoushan, Taizhou, Hefei, Wuhu, Maanshan, Tongling, Anqing, Chuzhou, Chizhou and Xuancheng On December 1, the State Council issued the outline of regional integration development plan for the Yangtze River Delta, and issued a notice requiring all departments in all regions to implement it in combination with the actual situation According to the observation of cypress blue device, the document points out the innovation opinions on the medical field in many places, which will have an important impact on the medical device field Before that, the first China International Import Expo announced: support the development of regional integration of the Yangtze River Delta and upgrade it to a national strategy The planning scope includes Shanghai, Jiangsu, Zhejiang and Anhui With 27 cities in Shanghai, Nanjing, Wuxi, Changzhou, Suzhou, Nantong, Yangzhou, Zhenjiang, Yancheng, Taizhou, Hangzhou, Ningbo, Wenzhou, Huzhou, Jiaxing, Shaoxing, Jinhua, Zhoushan, Taizhou, and Hefei, Wuhu, Maanshan, Tongling, Anqing, Chuzhou, Chizhou and Xuancheng as the center areas, the Yangtze River Delta region is driven by radiation How to affect the medical equipment industry? The analysis is as follows The document points out that county hospitals and medical and health institutions are encouraged to establish county medical service communities This means that in the future, with the implementation of the policy, the implementation of the county medical community in the Yangtze River Delta will bring new changes to the medical device enterprises in terms of recruitment, supply, distribution and supervision (screenshot source: Official Website of the State Council) At the macro level, the implementation of county medical community in the Yangtze River Delta has played a large role in IVD grassroots market expansion How to combine them? The previous experience of many provinces has given the answer The implementation of county medical community will promote the establishment of specialized alliances in multiple counties, which will greatly improve the concentration, and this is a good opportunity for a group of medical device enterprises with strong intensive service ability The county government takes the lead in the construction of county medical community, integrates basic medical and health resources, and establishes 1-3 County medical communities led by county-level public hospitals, with several other county-level hospitals, township hospitals, community health service centers, village health stations and community health service stations as members In terms of management, the president of the leading hospital is in charge of the county medical community, and a discussion and decision-making mechanism with the participation of the leading hospital and all member units is established In the aspect of financial management, it will also be unified: the financial affairs of each member unit in the county medical community are separately set up and accounted for, and managed by the county medical community The financial investment funds shall be allocated to the county medical community in a timely manner and used in accordance with the prescribed purpose of funds As for the management of medical devices, the provisions of the plan will unify the management of medical devices The county medical community shall set up a unique medical device purchase account, use the directory uniformly, implement the unified purchase and distribution of medical devices, and pay the money uniformly It should be noted that the government will support the county medical community as a unit to negotiate prices on the drug purchase platform, and the preparations of the member units of the county medical community can be circulated and used within the medical community This means that the medical community will assemble into an independent purchasing group to negotiate with dealers to exchange quantity for price According to the document, a standard management system should be established in the Yangtze River Delta Promote mutual recognition of inspection and test results in medical and other industries At the same time, the cross regional credit joint punishment system includes mutual recognition of dishonesty behavior standards, interaction of information sharing and communication of punishment measures (screenshot source: Official Website of the State Council) The directive has two implications First, for the practitioners of IVD enterprises, the principle of mutual recognition of test results has been implemented in many provinces and cities across the country, except for the specific items that cannot be mutually recognized In a way, the dosage and profit of reagents may decrease Second, the information sharing platform and the communication of punishment measures will make enterprises miss the cooperation opportunities For example: in June 2019, company a in Suzhou was investigated and filed by the drug regulatory bureau for selling unauthorized IVD instruments to local hospitals In February 2020, company a is going to cooperate with a famous IVD upstream manufacturer in Shanghai However, after the credit system in the Yangtze River Delta mentioned in the outline is shared, company a regrets to miss the opportunity of cooperation Not only market cooperation, but also technology research and development According to the Jiangsu Provincial Drug Administration, Shanghai, Jiangsu, Zhejiang and Anhui drug administrations jointly issued the implementation plan for pilot work of medical device registration system in the Yangtze River Delta region (screenshot source: Official Website of Jiangsu food and Drug Administration) It is reported that the initiative is carried out in accordance with the requirements of the notice on expanding the pilot work of medical device registrants issued by the State Drug Administration, with the integration of regional medical device industry in the Yangtze River Delta It can be seen that the Yangtze River Delta medical device registrant system integration formed "Medical device registrant system", an innovative reform in the medical device industry, was first piloted in Shanghai and then expanded to Tianjin and Guangdong In August 2019, the relevant notice of the State Food and drug administration made it clear that 21 provinces, autonomous regions and municipalities directly under the central government, including Beijing, Tianjin, Hebei, Liaoning, Heilongjiang, Shanghai, Jiangsu, Zhejiang, Anhui, Fujian, Shandong and Guangdong, participated in the pilot of medical device registrant system Previously, in the measures for supervision and management of medical device production implemented since October 2014, it was clearly stipulated that only when the medical device registration certificate was obtained, can the production license of class II and class III medical devices be applied for, and only when the production license was obtained, can the corresponding medical devices be produced and commissioned That is to say, the registration and production license are bound together, which must be completed by one entity Now, the system of medical device registrant has been reformed, allowing enterprises, institutions and personnel to apply for medical device registration certificate separately, and then entrust other enterprises to produce corresponding medical devices as registrant That is, registration and production license can not be completed by one entity "The registrant system realizes the deregulation of product registration and production license, which is more conducive to encouraging innovation, integrating social resources and accelerating the listing of medical device products," said Lin Senyong, director of the medical device regulatory office of Shanghai pharmaceutical regulatory bureau From the results of the current implementation of the system around, the pilot work of the registrant system has achieved some results For example, some enterprises simply understand the registrant system as entrusted production and fail to realize that the registrant has to bear the main responsibility for the quality management of the whole life cycle of medical devices; some enterprises deliberately split out the holder or trustee to enjoy the incentive policies during the pilot period (such as priority review); some holders and clients have intellectual property disputes According to incomplete statistics, Shanghai has been mentioned 50 times, Hangzhou 15 times, Nanjing 14 times, Hefei 13 times, Ningbo 11 times, Suzhou 6 times, Zhoushan 5 times, Jiaxing 5 times, Nantong 4 times, Wuhu 4 times, Wuxi 2 times in the whole outline This group of figures has appeared many times in today's official and unofficial reports, in order to prove the position and importance of each city in the future regional development Taking the field of in vitro diagnosis as an example, there are more than 70 medical devices with an output value of over 100 million, and a large number of excellent IVD enterprises at home and abroad, including Roche Diagnostics, Kehua biology, toujing life, Shanghai Zhijiang, Hisense healthcare, Hitachi, Danaher and other enterprises Jiangsu Province has gathered a number of biomedical technology centers, focusing on the development of medical devices, in vitro diagnostic reagents, traditional Chinese medicine health, and biomedical research and development.