Pilot program for medical device registration applicants in the Yangtze River Delta region announced

On October 30, 2023, to promote high-quality integrated development of the medical device industry in the Yangtze River Delta region and to further accumulate experience for the nationwide implementation of the medical device registrant system, the drug regulatory authorities of Shanghai, Jiangsu, Zhejiang, and Anhui jointly issued the "Implementation Plan for the Pilot Program of the Medical Device Registrant System in the Yangtze River Delta Region" (hereinafter referred to as the "Plan").

The Plan points out that the pilot program aims to explore the establishment of a medical device consignment production management system, explore innovative medical device supervision methods, explore the release of dividends from medical device registrants, optimize resource allocation, clarify cross-regional regulatory responsibilities, encourage medical device innovation, and better meet the growing demand of the public for high-quality health services.

"This is a policy we have long hoped for." Dr. Gong Xiaoyan, chairman of Suzhou Yinluo Medical Device Co., Ltd. (hereinafter referred to as Suzhou Yinluo) and senior researcher at Harvard University, told a reporter from the Daily Economic News. For medical device practitioners in the Yangtze River Delta region, the implementation of the Plan will fundamentally promote the development of the domestic innovative medical device field.

The Plan clarifies cross-regional regulatory work.

A reporter from the Daily Economic News found that,The "medical device registrant" system was first proposed on December 1, 2017, when Shanghai issued the "Implementation Plan for the Pilot Program of the Medical Device Registrant System within the China (Shanghai) Pilot Free Trade Zone." This means that the registration and production license of medical devices are "unbundled," meaning that qualified medical device registration applicants can apply for medical device registration certificates separately and can entrust qualified enterprises with production capacity to produce them.

In July 2018, the former Shanghai Municipal Food and Drug Administration issued an "Announcement on Expanding the Pilot Program of the Medical Device Registrant System Reform to the Entire City." The medical device registrant system expanded from a pilot program in the Shanghai Free Trade Zone to the entire Shanghai. On August 1, 2019, the National Medical Products Administration issued the "Notice on Expanding the Pilot Program of the Medical Device Registrant System" (hereinafter referred to as the "Notice"), deciding to expand the pilot program of the medical device registrant system to 21 provinces (autonomous regions and municipalities directly under the Central Government), including Shanghai, Zhejiang, Jiangsu, and Anhui, based on the pilot programs in the Shanghai, Guangdong, and Tianjin Free Trade Zones.

Compared with the above-mentioned Notice, this Plan further details the conditions and obligations and responsibilities of registrants and entrusted production enterprises, procedures, etc., and adjusts some clauses according to the specific situation of the Yangtze River Delta region, such as"Registrant conditions" have increased from 4 items in the Notice to 5 items, and "obligations and responsibilities of registrants" have increased from 7 items in the Notice to 12 items.

In addition, the cross-regional medical device consignment production management system puts forward higher requirements for regulatory work, and how the regulatory work is carried out and implemented has also become a hot topic of public concern. For example, how to break regional restrictions, how to achieve information sharing among different regions, how to divide regulatory responsibilities, and how to unify regulatory standards in various places.

It is understood that this Plan also makes relevant provisions on regulatory work. For example, in terms of division of regulatory responsibilities, the drug supervision and administration department in the location of the registrant is responsible for the supervision and management of the registrant within its jurisdiction, and the drug supervision and administration department in the location of the entrusted production enterprise is responsible for the supervision and management of the entrusted production enterprise within its jurisdiction. In addition, the Plan also states that it is necessary to strengthen regional regulatory coordination, strengthen in-process and post-event supervision, introduce third-party institutions and industry associations to participate in evaluation and collaborative management, and achieve social co-governance.

Policies promote innovation in domestic medical devices.

Previously, medical device product registration (listing) and medical device production licenses (production) must be the same entity, but the implementation of the Plan has "unbundled" the two,From a macro perspective, this will further subdivide the layout of the medical device industry and further optimize the allocation of cross-regional social resources, with R&D and production performing their respective functions.

For larger group companies, the implementation of the Plan allows them to fully consider land, labor, environmental protection, and logistics costs across provinces and regions, and reasonably optimize the allocation of internal resources. Wang Shumei, vice president of the Quality and Regulatory Affairs Department of United Imaging Healthcare Technology Group Co., Ltd., once said:"The cross-provincial pilot program of the registrant system has enabled enterprises to truly achieve cross-provincial "unbundling" of medical device product registration and production licenses, which is conducive to enterprises carrying out resource integration strategic layouts at the group level and achieving efficient development of group strategic synergy."

In addition, one of the major impacts of the implementation of the Plan is to accelerate the listing of innovative products. Gong Xiaoyan told a reporter from the Daily Economic News that in the innovative medical device industry, the R&D field and the production field are very different. The current implementation of the Plan allows enterprises to allocate resources more reasonably, concentrate their efforts on ensuring that innovative medical device products are more standardized in the R&D process, and safer and more efficient in product quality.

In the view of Shi Licheng, head of Beijing Dingchen Pharmaceutical Consulting Management Center, the medical device registrant system and the drug marketing authorization holder system introduced last year have similar aspects in releasing the vitality of innovative R&D. According to Shi Licheng's analysis, the domestic medical device field started late and its development is still incomplete. At present, many high-end and sophisticated core components of medical devices rely on imports. The implementation of the registrant system can amplify the R&D capabilities of individuals, institutions, and the entire sub-sector.

"Previously, when innovative research institutions developed new medical devices and did not have their own production facilities, they had to seek cooperation with production enterprises when the R&D was halfway through, otherwise, production and research would be difficult to continue. Now that the Plan has been introduced, the cost in this area has been greatly reduced, and research institutions and individuals can focus on R&D." Shi Licheng said.

In addition, Shi Licheng is optimistic about cross-regional and remote regulatory work, and he told a reporter from the Daily Economic News:"When the drug marketing authorization holder system was introduced, there was a lot of remote supervision. I believe there will be no problem with this (cross-regional supervision of the medical device registrant system)."

Especially for newcomers to the medical device industry, the implementation of the Plan will greatly reduce the cost of innovation and entrepreneurship in the early stages."First, samples of innovative products can be provided by the manufacturer to shorten the sample manufacturing time; second, new product developers no longer need to establish production facilities, but can focus more on strictly regulating product quality and R&D processes. We believe that these changes can make R&D more standardized, production more refined, and the division of labor will lead to a win-win situation." Gong Xiaoyan told a reporter from the Daily Economic News that after learning about the introduction of the Plan, Suzhou Yinluo plans to establish production facilities in other places to complete the division of R&D and production, and will open its unique production technology to the industry.

At the same time, Suzhou Yinluo will transfer the saved production cost resources to scientific research and innovation, increase the intensity of R&D cooperation with universities, research institutions, and medical teams, and increase the intensity of introducing new products.