CMO of medical devices with license separation will become a hot spot nationwide

Since Shanghai food and Drug Administration implemented the pilot of medical device registration and licensing system at the end of 2017, MAH (listing license holder system) of medical device version is rapidly promoted and implemented nationwide The separation of license and license of medical devices is expected to open up billions or even tens of billions of medical device CMO business market, making it a new outlet of the industry The official document of the first formal appearance of the MAH system for outsourcing demand, which is the No.44 document issued by the State Council on the reform of the review and approval system for medical devices in August 2015, clearly states that the binding mode of the past drug marketing license and production license should be unbound In November of the same year, the drug MAH system began to be piloted in ten provinces and cities across the country, and the "amendment to the drug administration law of the people's Republic of China (Draft for comments)" published by CFDA in October 2017 finally clearly released the signal to be implemented nationwide Mah greatly mobilized the enthusiasm of drug manufacturers in research and development, which spread to the medical device industry Figure 1 MAH development of medical devices In December 2017, Shanghai food and Drug Administration issued and implemented the implementation plan of pilot work of medical device registrant system in China (Shanghai) pilot free trade zone The pilot work of medical device registrant system started in Pudong, Shanghai The implementation of the pilot plan of "license separation" means that qualified registration applicants can apply for medical treatment separately in the future The device registration certificate is then entrusted to qualified and productive enterprises for production, which will greatly promote the innovative research and development, specialized and large-scale production of medical devices On February 8, 2018, only two months after the pilot implementation of the medical device registrant system, the single channel ECG recorder of Shanghai Yuanxin Medical Technology Co., Ltd obtained the registration certificate of the second type of medical device product issued by Shanghai food and drug administration, becoming the first successful pilot product of the medical device registrant system The whole review and approval process only took 23 working days The statutory working time limit has been reduced by more than 80% On May 24, 2018, the State Council issued the plan for further deepening the reform and opening up of China (Guangdong), (Tianjin) and Fujian free trade pilot zones, which clarified the reform of the medical device registrant system and has been approved to expand from Shanghai to Guangdong and Tianjin The pilot scope of "separation of license and certificate" was further expanded At the same time, the second pilot product of medical device registrant system in Shanghai, surgical power system, has also been successfully listed The registered enterprise is Medtronic, and the entrusted manufacturer is Jabil Technology (Shanghai) Co., Ltd On July 5, 2018, Shanghai food and Drug Administration issued the announcement on expanding the pilot of medical device registrant system reform in Shanghai to the whole city, and decided to expand the pilot to the whole city Guangdong free trade zone and Tianjin Free Trade Zone "untie" the registration certificate and production license of medical devices, as well as Shanghai's expansion of the pilot to the whole city of Shanghai, marking that MAH of medical devices has been promoted from pilot to full implementation in just half a year, which also means that cdmo in the field of medical devices in China will usher in great development In October 2018, Shenzhen Mindray Technology Co., Ltd was awarded the first class II medical device product registration certificate after the implementation of Guangdong medical device registration system, and the company's injection pump became the first medical device product approved for listing in accordance with the implementation plan for pilot work of Guangdong medical device registration system CMO of domestic medical devices has become a hot topic CMO / cdmo of medical devices has become a relatively mature business model in foreign countries According to global medical device contract manufacturing market 2018 - industry analysis, trends released by research and markets, Market size and forecasts up to 2024 forecasts that the global medical device contract production market will grow at a compound annual growth rate of 10.77% in 2018-2024, among which the representative enterprises include benchmark electronics, Jabil Circuit (Jabil), Flextronics (Flextronics), etc From the perspective of large international companies, in order to cope with the cost pressure and the challenges of emerging companies, to improve the operating efficiency and maintain the profit margin of the company, large-scale R & D and production outsourcing mode is becoming more and more obvious The equipment giants, such as Medtronic, Johnson & Johnson, BD, have adopted outsourcing strategies The pilot and full implementation of medical device registrant system is the general trend of production outsourcing It can continuously allocate R & D innovation and large-scale production and other factors in an intangible way, inhibit the low-level repeated construction of medical device industry, and stimulate the vitality of innovation and development of medical device industry Innovators can focus on product R & D, and production can be directly entrusted to With the development of qualified enterprises, the outsourcing service of CMO / cdmo has gradually become a hot spot in the industry At present, the domestic system has just been opened, the value recognition and acceptance of CMO / cdmo in the medical device industry need to be improved, the professional talent team needs to be built, and the domestic medical device CMO enterprises are starting Currently, Juyi technology, Zhizhong technology, aozida, etc are seen in the newspapers Juyi Technology Founded in September 2014, Juyi technology is committed to becoming China's leading provider of medical device R & D, registration, production services and complete product solutions (CRO + CMO for device R & D) Its production service base is located in Jiangsu medical device technology industrial park, with 1200 square meters of active product assembly and testing workshops, and 800 square meters of 100000 level dust-free and sterile workshops meeting GMP requirements for the second stage Class A and class III medical devices and consumables production Juyi technology is one of the earliest and very few start-ups in the industry that foresees the trend of separation of medical devices and certificates and actively deploys cro and CMO services in advance It also participated in the research of early medical device holder system and policies In July this year, the company has completed a round of financing invested by Huatai health fund and Sinopharm capital, with a total amount of 42 million yuan, to continue to expand the scale of medical device R & D service team, laboratory, production service base and global market business development Zhizhong technology Zhizhong technology is located in Wuhan Optics Valley Biological city It is the first consulting service platform for medical device innovation and entrepreneurship technology laws and regulations listed on the new third board in China It has successively obtained investment from Tsinghua enlightenment venture capital and Jingwei China In April 2018, Zhizhong science and technology officially released the integrated medical device service platform, Zhizhong medical device CMO and the third-party inspection and research platform, which integrates laws and regulations, clinical research and development, testing and manufacturing, at the CMEF conference The completion ceremony was held in October 2018 The project covers an area of nearly 7000 square meters It has three production lines of active medical devices, passive medical devices and in vitro diagnostic reagents It has reached the standard of grade 10000 in aseptic workshop and grade 100000 in diagnostic reagent workshop It can provide a series of production clothes for wearable devices, household devices, general active devices, catheter products, application products, nucleic acid reagents, immune reagents and other products Business, including registration test samples, clinical test samples and mass production, etc Aozi Da Aozi Da medical device group was founded in 2004 It is a third-party industrial service provider of medical devices Provide scientific research transformation and manufacturing platform (cdmo), global registration and clinical trial platform (CRO) for medical device industry On April 11, 2018, aozida's cdmo platform landed in Shanghai and signed a contract with the first batch of users, which is also the world's first cdmo + cro platform for the whole industry service of medical devices In the future, there will be 8 professional cdmos in ozida, which will provide all-round and one-stop medical device industry solutions for medical device developers, producers, users and the government Its customers include not only international device giants such as general, Philips, Siemens, but also 70% domestic medical device listed companies such as Mindray medical, BGI and Weigao group Figure 2 planning and layout of aozida cdmo platform