Just now! 21 provinces and cities "relaxed medical device regulations", and the separation of licenses and factories spread across the country

The medical device registrant system has been expanded from pilot projects in Shanghai, Guangdong, and Tianjin to 21 provinces and municipalities across the country, and the medical device industry has ushered in a breakthrough change!
On August 1, the State Food and Drug Administration issued the "Notice on Expanding the Pilot Project of the Medical Device Registrant System", clarifying that the pilot provinces and cities of the medical device registrant system have expanded to 21: Beijing, Tianjin, Hebei, Liaoning, Heilongjiang, Shanghai, Jiangsu, Zhejiang, Anhui, Fujian, Shandong, Henan, Hubei, Hunan, Guangdong, Guangxi, Hainan, Chongqing, Sichuan, Yunnan, Shaanxi Province (autonomous regions, municipalities).
Jiangxi Xiangen Medical Technology Development Co., Ltd.
Previously, it was necessary to obtain a medical device registration certificate to apply for a Class II or Class III medical device production license, and the production license was also the entry condition for the production and entrusted production of the corresponding medical devices.
After the implementation of the reform of the medical device registrant system, "certificate separation", registration and production license can be completed by different entities, completely separating the two, loosening the bond, and greatly promoting the innovative research and development of medical devices and professional and large-scale production.
From December 2017 to July 2018, this system was partially piloted and fully implemented in Shanghai. After that, the "certificate-factory separation" medical device registrant system began to expand its scope of implementation. The State Council issued a reply notice in May of the same year, and Guangdong and Tianjin have successively allowed the implementation of this system. And this time, the Drug Administration issued a document, and all 21 provinces and cities across the country have implemented it, which can be said to be implemented at a rapid speed!

The "Medical Device Registration Licensee System" that is accelerating across the country

In December 2017, the Shanghai Food and Drug Administration issued the "Implementation Plan for the Pilot Work of the Medical Device Registrant System in the China (Shanghai) Pilot Free Trade Zone" (hereinafter referred to as the "Plan"), and the medical device registrant system began to be piloted in Pudong, Shanghai, which means that the "certificate-factory separation" of the medical device industry has ended the era of manufacturer hegemony!

Only two months later in February 2018, Shanghai Yuanxin Medical's single-channel electrocardiograph obtained the second-class medical device product registration certificate issued by the Shanghai Food and Drug Administration, becoming the first medical device approved for marketing in accordance with the "Plan". This is also the first product in China to enjoy the new policy of the medical device registrant system. The entire review and approval process took a total of 23 working days, which is more than 80% shorter than the statutory working time limit!

Only 6 months later in May 2018, the State Council issued the "Plan for Further Deepening the Reform and Opening-up of China (Guangdong), (Tianjin), (Fujian) Pilot Free Trade Zones", which clarified that the reform of the medical device registrant system has been approved to be expanded from Shanghai to Guangdong and Tianjin. The pilot scope of "separation of licenses and certificates" has been further expanded.

In July 2018, also 2 months later, Shanghai went from piloting in Pudong to implementing it in the whole city in just 7 months! This not only means the expansion of the implementation scope of Shanghai, but also the expansion from the free trade zone scope only allowed by the "Implementation Plan for the Pilot Work of the Medical Device Registrant System in the China (Shanghai) Pilot Free Trade Zone" to other regions, which is a big step from piloting to full implementation!

Medtronic and GE are eager to try, and a batch of products have been approved

In fact, since the Municipal Food and Drug Administration issued the "Implementation Plan for the Pilot Work of the Medical Device Registrant System in the China (Shanghai) Pilot Free Trade Zone" (hereinafter referred to as the "Pilot Plan") in December last year, the response from industry enterprises has been very enthusiastic.
A number of local medical device companies such as MicroPort, Essence, Kellytech, and Fosun said that they would optimize resource allocation and improve corporate competitiveness through the pilot;

From a national perspective, some fast-growing new innovative medical device companies such as TCL Medical also intend to set up their R&D centers in Shanghai as registrants;

At the same time, the headquarters of multinational companies such as Johnson & Johnson, Medtronic, GE, and BD are also paying close attention to the progress of the pilot work, hoping to achieve the optimal path of localization of imported products through participating in the pilot.

In January this year, the knee orthosis developed by the team of Academician Dai Kerong of the Chinese Academy of Engineering and Shanghai Jiaotong University Intellectual Property Management Co., Ltd. as the applicant obtained the product registration certificate in accordance with the pilot requirements, becoming the first passive non-implantable patient-matched medical device produced by a scientific research enterprise as the registrant, clinically led, medical-engineering interaction, and customized additive manufacturing process.

So far, 9 products from 6 companies in Shanghai have been approved in the pilot work, and 35 products from another 23 companies have been agreed to be included in the pilot scope.
Medical devices usher in the era of outsourcing

It is worth noting that the single-channel ECG recorder of "Telecentric Medical", the first domestic product to benefit from the new policy of the medical device registrant system, was commissioned to be produced using the production site and equipment of its parent company MicroPort Medical;

The "Medtronic" surgical power system, which was also approved, had applied to the Bureau for registration of imported Class II products before being included in the pilot. It is worth mentioning that this is the result of the strong combination and responsibility connection of two non-related companies after the semi-finished products are produced by Jabil Technology (Shanghai) Co., Ltd. It is not difficult to see that under the medical device registrant system, the industry's R&D and production patterns will be changed, "letting professionals do professional things", more professional R&D companies and institutions, as well as professional OEM production companies will emerge, and outsourcing services will become an irreversible industry development trend.

For example, Jabil Technology, the manufacturer entrusted by Medtronic this time, is one of the three giants of global electronic product OEM (Foxconn, Flextronics, Jabil), which also means that after the "separation of license and factory", the tentacles of these professional OEM industrial giants will accelerate the extension of the medical device industry.