The State Council will do it again, and the medical device industry will be revolutionized!

Source: sepiland equipment registration and production license are separated from each other on May 25, 2018 Two more provinces have been approved for pilot A few days ago, the State Council issued the reform and opening plan for further deepening China (Guangdong), (Tianjin) and Fujian free trade experimental zones, which made specific arrangements for the next reform direction of the three free trade zones It is worth noting that for Guangdong and Tianjin Free Trade Zone, the State Council respectively proposed that: allow the registration applicant of medical devices in Guangdong free trade zone to entrust Guangdong medical device manufacturer to produce products; allow the registration applicant of medical devices in Tianjin Free Trade Zone to entrust Tianjin medical device manufacturer to produce products As a result, the "separation of certificates and licenses", aiming at promoting innovative research and development and the reform of medical device registration system of specialized and large-scale production, has been approved to expand from Shanghai to Guangdong and Tianjin The measures for the supervision and management of medical device production implemented in October 2014 clearly stipulates that only when the medical device registration certificate is obtained can the production license of the second and third categories of medical devices be applied for, and only when the production license is 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 The reform of medical device registrant system directly breaks through the above policies, allowing enterprises, institutions and personnel to apply for medical device registration certificate separately, and then entrust other enterprises to produce corresponding medical devices as registrants That is, registration and production license can not be completed by one entity Since last year, with the approval of the State Council, Shanghai free trade zone has taken the lead in launching the innovation and reform of the medical device registrant system nationwide, which has brought about a major change in the industry So far, Shanghai's reform has achieved results The accession of Guangdong and Tianjin free trade zones will accelerate the subversive impact of medical device registrant system on the industry Medtronic, minimally invasive "eat crabs", global OEM giants also came to Shanghai medical device registration system reform, the first successful eat crabs is Shanghai minimally invasive Shanghai Yuanxin Medical Technology Co., Ltd entrusts Shanghai minimally invasive electrophysiological Medical Technology Co., Ltd to produce a single channel ECG recorder Both the entrusting party and the entrusted party are subsidiaries of Shanghai minimally invasive group Recently, Shanghai food and Drug Administration released the details of Medtronic's newly licensed product registration certificate of operation power system The relevant information shows that Medtronic's product is also a commissioned production mode, resulting in another great achievement of the reform of Shanghai medical device registration system Different from Shanghai minimally invasive, the entrusted manufacturer of Medtronic is Jabil Technology (Shanghai) Co., Ltd (hereinafter referred to as "Jabil Shanghai"), which is a professional third-party OEM enterprise Medtronic (Shanghai) Management Co., Ltd., as the holder of the registration certificate, entrusts Jabil to produce the Medtronic brand medical device products of "hxzz" The top three global electronic product manufacturers are Foxconn (Hon Hai), Flextronics and Jabil Jabil group, headquartered in the United States, is one of the top 500 companies in the world, with sales volume of USD 19.1 billion in 2017 Jabil Shanghai, a subsidiary of Jabil group, was founded in 2002 It is wholly foreign-owned At present, it is the Asia Pacific headquarters developed by Jabil group, one of the major production bases in mainland China, and the medical product production base in Asia It is reported that Jabil Shanghai has developed and designed electronic circuit board components and systems for global medical equipment giants such as GE, Philips, Abbott, poco, Johnson & Johnson, Medtronic (including kohui) In addition, according to the data of China Medical Insurance chamber of Commerce, Jabil Shanghai has always been on the top 10 list of Chinese medical consumables export enterprises As the third largest global OEM giant, Jabil Shanghai has strong production capacity, but its R & D capacity is relatively limited, so it is difficult to apply for medical device registration certificate Previously, due to policy limitations, it was difficult to carry out business in domestic commissioned production market, and its business is concentrated in International market Medical equipment, outsourcing era! In the reform of Shanghai, it is allowed to commission the production of products in the incubation stage, allow the registrant to commission the production in multiple points, and allow the entrusted enterprises without production qualification to submit the registrant's medical device registration certificate to apply for production license The detailed reform measures mentioned above will be implemented in Guangdong and Tianjin, which are about to try out the reform of medical device registrant system It is unknown whether they will follow suit or not It depends on the further policies of the two places However, from the practice of Shanghai, the reform of medical device registration system has brought changes to the industry The pilot of Shanghai minimally invasive technology Co., Ltd has integrated and optimized the internal resources of large-scale medical device enterprise groups The pilot projects of Medtronic and Jabil Shanghai are more reproducible Under the system of medical device registrant, it is also theoretically feasible to change the entrusting party and the entrusting party This mode of cooperation may serve as a starting point to open a new path for the localization of foreign-funded machinery enterprises in China The more far-reaching impact is that with the spread of the medical device registration system, the industry's R & D and production pattern will be changed, more professional R & D enterprises and institutions, as well as professional OEM manufacturers will emerge, and outsourcing services will become an irreversible industry development trend Among them, the existing medical device manufacturing enterprises will gradually differentiate, some of them will be closer to the former, some of them will be closer to the latter, the division of labor in the industry will be more reasonable, the specialization ability of enterprises will be stronger, but the gap will also be widened, and the enterprises standing at the top will be stronger and stronger The non-traditional equipment enterprises and professional third-party OEM enterprises like Jabil may also penetrate into the field of Chinese medical device production, and become a force that cannot be ignored in the industry Foxconn, Flextronics and Jabil are the three global electronics OEM giants As early as 2010, Flextronics has made a breakthrough in the field of medical device OEM Flextronics China has established production lines for medical devices in Suzhou and Guangdong, and its customers include Johnson & Johnson, Abbott, Smith & nephew, Medtronic, insulet, etc 70% of the world's blood glucose meters are said to be OEM manufactured by Flextronics Jabil Shanghai's breakthrough in the field of medical device OEM started a few years ago Foxconn, in recent years, has been looking for OEM suppliers of medical equipment products around the world, and has established cooperative relations with sotera and Varian in the United States Compared with the profit margin of only 4% - 7% for the OEM of consumer electronic products, the profit margin of more than 20% for the OEM of medical equipment, and the faster market growth, are not less attractive to the third-party OEM enterprises It is the common practice of many professional OEM enterprises to extend and transform to the field of medical device OEM With the opening of domestic medical equipment OEM policy, the outsourcing era of medical equipment will accelerate!