In order to advance regulatory innovation and high-quality industry development of medical devices in the Guangdong–Hong Kong–Macao Greater Bay Area (“GBA”), a joint research group was established by the Guangdong-Hong Kong-Macao Greater Bay Area Sub-center for Medical Device Evaluation, NMPA (“GBA Sub-center”) and the Guangdong Medical Products Administration at the end of 2022 upon the approval of the National Medical Products Administration (“NMPA”), to research the medical device industry in nine mainland cities within the GBA.
According to Liu Bin, Director of the GBA Sub-center, the research group completed three rounds of field research in Guangzhou-Foshan-Zhaoqing, Shenzhen-Huizhou-Dongguan and Zhuhai-Jiangmen-Zhongshan, respectively, from February 14 to 17, March 15 to 17 and March 22 to 24 this year.
During the research, a total of nine symposiums were held, in which 152 enterprises were invited and 187 questions were answered on site, and visits were paid to eight industry clusters in Huangpu and Nansha, Guangzhou, Songshan Lake, Dongguan, and Zhuhai High-tech Zone, one key platform - National Innovation Center for Advanced Medical Devices in Shenzhen, and 11 manufacturing enterprises to listen to the most pressing difficulties of high concern to enterprises and their demands on regulators, and understand the development needs, key development directions and policy service requirements of the medical device industry in the region.
Industry moving toward high-quality development
Possessing rich forms and clear tiers
With the acceleration of economic development and the continuous improvement of people’s living standards, people’s consciousness of health care is also continuously increasing. As an important branch of the health industry, medical devices strongly support medical institutions’ diagnosis and treatment activities. At the frontier of China’s reform and opening-up, the GBA features a highly active market economy and a flourishing medical device industry that ranks high in China in terms of industry scale, number of enterprises, technological innovation, etc.
According to Liu Bin, the joint research collected basic information on the medical device industry in various cities by fully utilizing methods such as questionnaire surveys, symposium interviews and site visits and enabled the research group to gain an understanding of the situation and characteristics of the medical device industry in the GBA.
Currently, in the GBA, there are 346 registrants of three domestic classes of medical devices, 1,833 approval documents issued for medical devices registered under three domestic classes, 692 valid import filing certificates, 402 approval documents issued for medical devices registered under import Class II and 249 approval documents issued for those registered under import Class III.
From the perspective of the filing of clinical trial institutions for medical devices, a total of 1,177 institutions in China have completed filing as clinical trial institutions for medical devices since the release of the Administrative Measures for the Conditions and Filing of Clinical Trial Institutions for Medical Devices on January 1, 2018. Among them, the numbers of those filed in Guangdong, Shandong, Jiangsu, Henan, Beijing and Zhejiang rank among the top five in China.
In 2022, the NMPA approved 5,692 registration applications of domestic Class III medical devices, including 1,844 initial registration applications, 1,915 registration renewal applications and 1,933 applications for changes in registration. Among them, Jiangsu (395 applications), Guangdong (319 applications), Beijing (254 applications), Shanghai (174 applications) and Zhejiang (145 applications) were the top five regions in the number of approved initial registration applications of domestic Class III medical devices, accounting for 69.7% of the total number thereof in 2022, up 1.8% compared to 2021.
From 2014 to 2022, the NMPA approved a total of 189 innovative medical devices. Among them, Beijing, Shanghai, Guangdong, Jiangsu and Zhejiang had the highest numbers of approved innovative medical device products and corresponding enterprises, accounting for about 82.5% of all the said 189 devices.
Liu Bin stated that Guangdong Province’s medical device industry currently has the largest scale in China, however, its structure remains to be further optimized, and newcomers are catching up; in the GBA, the medical device industry in the nine mainland cities have rich development forms, leading enterprises and startups are splendid in their own ways, and the tiers are clear.
The research group conducted publicity during its visits, answered questions during symposiums and collected information and sent feedback simultaneously. It visited eight development institutions and one key platform in Zhuhai and Guangzhou in late May and early June, respectively, and answered more than 30 questions on site. During the research, the research group gained insight into the main research content, research progress and achievement transformation plans of various projects and the prior communication and guidance requests for the GBA Sub-center, to continuously improve information on the projects of main medical device development institutions within the GBA.
The research group collected some common issues during the research. Liu Bin stated that the GBA Sub-center will next launch work according to industry requests, including conducting industry research in Hong Kong and Macao, looking into and analyzing the characteristics of the medical device industry in the GBA, summarizing common issues raised by manufacturing enterprises and key issues related to bottlenecks in technologies, and establishing a real-time dynamic regulation data platform in the region.
Improving the innovation service mechanism
Accelerating the transformation of innovation achievements
The medical device industry is a multidisciplinary, knowledge-intensive and high-value-added emerging industry that requires regulators’ services and support for its rapid development. The GBA Sub-center is a strategic “outpost” of the regulators to serve and support industry development in the GBA and, in order to advance device innovation achievement transformation, industry agglomeration and innovative development in the GBA, has been continuously improving its innovation service mechanism since its official establishment and accumulating strength to empower the innovative development of medical devices in the GBA.
The R&D of innovative technologies in China mainly relies on universities and institutions, however, their R&D results are more academic in nature and their transformation rate of achievements has long remained between 4% and 5%, far lower than the 25% to 30% in Western developed countries. To improve the transformation rate of sci-tech achievements, the GBA Sub-center held 10 sessions of exchanges and discussions with the South China University of Technology Scientific Research Base on Medical Device Regulation in 2022, to track the academic frontiers of five main directions and explore and respond to 63 regulatory issues.
State-level innovation platforms such as the National Innovation Center for Advanced Medical Devices have strong research, achievement transformation and regulation interpretation capabilities, however, during the transformation of innovative products, new key technologies can bring forth regulatory issues. As a result, the GBA Sub-center plans to provide proactive services to track the whole process, identify issues early and propose effective solutions.
According to Liu Bin, the GBA Sub-center has innovated its service concept, in which the professional quality and knowledge reserve of related personnel in terms of innovative medical device applications are improved through training, services are actively extended to primary-level parks to familiarize enterprises with the application process of innovative medical devices, and innovative medical device-related policies are promoted and publicized among universities, research institutes and medical institutions to reduce detours during clinical studies and research achievement implementation and accumulate energy for the sources of innovative medical devices.
To discover more innovative medical device products, the GBA Sub-center guides universities, research institutes and medical institutions on whether a product is a medical device, whether it is an innovative medical device, and what fundamental work (such as patent applications) is required for innovative device applications after transformation, guides startup medical device enterprises through policy training and face-to-face question answering, and provides technical training to manufacturing enterprises with a foundation in regulation and policy research so that they understand product and technology development trends and which may become the next new direction of innovation.
For medical device products that have passed the special review of innovative medical devices, the GBA Sub-center designates personnel for connection and follow-up, who discuss major technologies, major safety aspects, clinical trial protocols, and the summaries and evaluations of phased clinical trial results with applicants and timely communicate with, provide guidance to and actively serve them. For innovative medical devices of which registration applications have been accepted, the GBA Sub-center gives priority to the technical reviews thereof to accelerate their registration and marketing.
Liu Bin stated that the GBA Sub-center will continue to improve its innovation service mechanism, strengthen service support for key enterprises and projects and build itself into a practical platform that drives high-quality integrated development in the region, a cooperation platform that deepens the review and approval system reform and an incubation platform that serves the innovative development of the medical industry.
Source: Pharmaceutical Economic News