Right before the kick-off of competitions in the China (Zhejiang) Pilot Free Trade Zone - Xiaoshan Division of the 5th China Medical Devices Design & Entrepreneurship Competition 2022, the Medical Device Industry Technology Innovation Services and Investment and Financing Forum (“Forum”) was held successfully at Hangzhou Blossom Water Museum Hotel on September 21, where many industry experts and innovative project representatives had in-depth discussions on the current medical device innovation trends and investment and financing situation.
Gu Hanqing, a review expert from the National Medical Products Administration (NMPA) for innovative medical devices, gave a speech on the topic of technical requirements and discussion of the national special approval program for innovative medical devices, and he mentioned that the NMPA, in order to accelerate the marketing of innovative medical devices, issued the Special Approval Procedures for Innovative Medical Devices in February 2014, and released a new version of the said document on November 2, 2018, which came into force on December 1, 2018, emphasizing that approved innovative medical devices can take the green channel to accelerate marketing and reduce enterprises’ investment so that more innovative high-tech medical devices can benefit people more quickly.
He also mentioned that nearly 2,000 applications for innovative products had been received by September 2022, including 95 imported products and other domestic products; more than 300 products entered the national special channel for innovative medical devices, including more than 70 products completed registration applications to obtain product registration certificates.
He summarized which medical devices are innovative products, and he specially emphasized that the innovative medical devices applied for should be specific products, meaning that “innovative” refers to products instead of technologies, and innovative products have four distinctive features; there are also specific requirements for the patented inventions of core technologies of innovative medical devices: core technologies should be used for the first time in the products applied for in China, and the use of core technologies should significantly improve the product performance to the international leading level.
Qi Weiming, Director of the Zhejiang Center for Medical Device Evaluation, gave a keynote speech titled Medical Device Review and Approval and Innovation Services Work in Zhejiang Province. He presented the background of medical device innovation development in the province: it is mentioned in the Implementing Opinions on Accelerating the Innovative Development of Life and Health Science and Technology of the General Office of the People’s Government of Zhejiang Province that the province should increase support for innovative products, to realize clinical study approval or marketing of more than 20 innovative drugs, more than 20 innovative medical devices, and more than 100 Class III medical devices by 2022; the province is also improving the priority review mechanism for innovative products, setting up a green channel for approving drugs and innovative medical devices from key parks, increasing policy support for the first major medical devices as well as drugs and medical devices on the Zhejiang High-Quality Manufacturing List, and actively advancing the implementation of the medical device registrant system. He also detailed the personnel and functional organization distribution and job functions of the Zhejiang Center for Medical Device Evaluation and focused on explaining the application process for the review and approval channel in Zhejiang Province for innovative medical devices.
Then, Sha Liya from the Zhejiang Institute of Medical Device Testing expounded the innovative medical device testing support and digital service platform: as the marketing registration of medical device products requires inspection and testing, a digital service platform has been launched by the Zhejiang Institute of Medical Device Testing to provide testing support, and she then detailed the operation process on the said platform. She also summarized the policies of the Zhejiang Institute of Medical Device Testing: the Zhejiang Institute of Medical Device Testing opens a green channel for medical device products that enter the special approval channels of the state and the province for innovative products, designates dedicated acceptance personnel to give priority to the acceptance of the said products, and marks the said products during the acceptance for whole-process tracking and priority testing. The Zhejiang Institute of Medical Device Testing has provided testing services for a total of 55 innovative products in Zhejiang Province, of which 21 products have been approved for marketing, including three Class III products and 18 Class II products.
With the release of the related regulations for medical devices and the implementation of the general guideline system for clinical evaluation, clinical evaluation and registration have become an industry hotspot. Xu Xiaolei, Deputy Director of the Clinical Department of RAMED (Beijing) Medical Technology Co., Ltd. (“RAMED”), shared information on the R&D system, product lifecycle planning, clinical evaluation, registration process, and cautions that should be completed before the marketing of medical device products. RAMED contributes to the registration and marketing of new medical device products through its more than 20 years of experience in IVD and medical device product registration, more than 1,000 successful cases, and more than 150 clinical institution partner resources.
Chen Jian, a partner of Weiyi Capital, gave a speech on the topic of investment, financing, and M&A of medical device enterprises today. He analyzed the current macro-environment of medical device investment and investment deadlocks faced by medical device innovation enterprises and put forward ways to break the deadlocks.
During the Forum, the participants also visited the Xiaoshan Innovation Polis, the Xindao Langu Biomedical Industrial Park, and the Zhilian International Life Sciences Innovation Center, to learn about park planning and construction, industrial policy support, etc.
The Xiaoshan Innovation Polis focuses on cultivating the future manufacturing cluster of life sciences, implementing a group of strengthening and complementary projects, building the life sciences industry chain that involves precision medicine, innovative drug R&D, precision medical devices, and life health services, and constructing the research-based and industrialization-based enterprise ecosystem with scientists at the core. The Xiaoshan Innovation Polis aims to strengthen advantageous biomedical fields such as tumor-targeted innovative drug R&D, organ transplantation, and gene and cell therapy and foster and develop high-end medical devices such as digital diagnosis and treatment equipment, high-end in vitro diagnostic devices, implantation and intervention devices, and diagnostic reagents. In reliance on industrial parks such as the Life and Health Valley and the Hangzhou Bay Life Science Park, the Xiaoshan Innovation Polis is accelerating the gathering of life science innovation elements and building itself into a leading life and health industry cluster.