National CPPCC Standing Committee Member Chang Zhaohua Urges Accelerated Implementation of Policies Allowing Cross-Regional Production Resource Allocation for Medical Device Enterprises

The STAR Market Daily (Shanghai, reporter Zhu Jieyu) reported,Reporters from The Science and Technology Innovation Board Daily learned that during this year's two sessions of the National People's Congress and the Chinese People's Political Consultative Conference (CPPCC), Chang Zhaohua, member of the CPPCC National Committee and Chairman and CEO of Shanghai MicroPort Medical (Group) Co., Ltd., submitted four proposals. Three of them are related to the medical industry, covering topics such as the technical review of Class II medical device registration, cross-administrative region allocation of production resources for medical device companies, and resource sharing during the research and development phase of medical device companies.

Proposal One: Further Improvement of the Technical Review for the Registration of Class II Medical Devices

In 2021, the National Medical Products Administration (NMPA) organized the revision of the "Operational Specifications for the Registration and Approval of Class II Medical Devices Manufactured in China" and issued nearly 200 related technical review guidelines, achieving significant results. At the same time, drug regulatory authorities in multiple provinces and cities, including Zhejiang Province, Guangdong Province, Beijing, and Shanghai, successively introduced "Special Review Procedures for Innovative Class II Medical Device Products," promoting industrial development.

However, due to certain differences in the knowledge structure, professional level, and comprehensive judgment ability of reviewers across regions, there are varying focuses and inconsistent standards in the review of similar products conducted in different provinces and cities. The lack of unified review standards has caused certain困扰 for companies and also affected the efficiency and quality of the review process, thereby impacting the control over the safety and effectiveness of Class II medical devices.

In order to further improve the technical review of Class II medical device registration and unify the review standards across China, Chang Zhaohua proposed the following:

1. Promote the reference or direct adoption of the quality management system of the Center for Medical Device Evaluation of the National Medical Products Administration within provincial, autonomous region, and municipal-level medical device technical evaluation institutions. Continuously improve the workflow for the technical evaluation of Class II medical devices to ensure the quality of technical reviews.

2. Accelerate the release of more technical review guidelines for Class II medical devices to unify the standards for technical review of the same product across different regions, thereby reducing inconsistencies caused by individual reviewers' cognitive and interpretive biases.

3. Strengthen the professional construction of review teams across China, enhance the professional training and assessment of reviewers, and establish a unified national assessment and authorization standard. Reviewers can only conduct technical reviews after undergoing uniform training, qualification recognition, and authorization, to ensure that all reviewers in China execute reviews with the same level of capability and adhere to consistent standards.

4. Promote the informatization of technical review in various regions in China, and increase information transparency; encourage the electronic submission of registration materials for Class II medical devices; for Class II medical devices approved through innovative, priority, or special approval procedures, it is recommended that their technical review reports be disclosed nationwide in China.

5. Establish a consultation and reconsideration mechanism to enhance communication, exchange, and collaboration among review personnel across different regions. If a registration applicant has questions regarding the review conclusion of a provincial medical device review center before the final decision of non-registration is made, it is recommended that the applicant can file a request for reconsideration, which will be uniformly organized by the Center for Medical Device Evaluation of the National Medical Products Administration.

Proposal Two: Promoting the Cross-Administrative Region Allocation of Production Resources for Medical Device Enterprises

Regional integration is becoming the main battlefield and primary engine for leading national economic transformation and development. The regional integration of the medical device industry, in particular, is conducive to forming distinctive, large-scale national and regional medical device industrial clusters, which can optimize resource allocation to the greatest extent.

However, under current regulations, due to factors such as local supervision and regional protection, medical device companies seeking to add production sites across administrative regions are still required to establish a new company locally, reapply for product registration, and then apply for a production license. This greatly restricts the ability of medical device companies to rationally allocate production resources across administrative regions.The National Medical Products Administration (NMPA) has also been actively formulating relevant regulatory policies. For instance, in the "Measures for the Supervision and Administration of Medical Device Production (Draft for Comments)," it proposed that "If production sites are established across provinces, autonomous regions, or municipalities, an application for a medical device production license must be submitted to the drug regulatory authority of the province, autonomous region, or municipality where the new production site is located."

International practices do not impose restrictive requirements on medical device companies setting up production sites across administrative regions; they only need to specify the production address and corresponding production activities during product registration.To keep the responsibility主体 of medical device companies unchanged, allowing enterprises to allocate production resources across administrative regions is more conducive to maintaining the consistency and continuity of the quality management system and压实注册人全生命周期质量管理的主体责任. Therefore, Chang Zhaohua suggests the following:

1. Accelerate the implementation of relevant policies and regulations to allow medical device companies to add new production sites across administrative regions (provinces, autonomous regions, and municipalities) while keeping the production license entity unchanged, and clarify the closed-loop process and requirements for "application-acceptance-approval-post-certification supervision."

2. Establish a cross-regional communication and supervision mechanism, clarify the situation notifications between regional regulatory agencies, further deepen regional regulatory collaboration, and implement a mutual recognition mechanism for inspection results of medical device companies.

3. Build a national medical device enterprise information data platform, establish a unified medical device industry database and comprehensive supervision platform, and achieve data interconnection between different levels of medical device regulatory authorities through informatization and digital means to ensure high-quality and efficient supervision.

4. Strengthen the main responsibility of enterprises, urge production enterprises to strengthen the management of the entire production site, the entire production process, and the entire life cycle of products. Establish a quality management system adapted to the cross-administrative region allocation of production resources and ensure its effective operation to guarantee the safety and effectiveness of medical devices.

Proposal Three: Allowing Medical Device Enterprises to Share Resources During the R&D Phase to Stimulate Innovation Vitality

From 2017 to 2021, the number of medical device manufacturing enterprises in China increased from over 16,000 to more than 28,000. Small and medium-sized enterprises have clearly become a significant driving force for the development and innovation of the medical device industry. However, these numerous small and micro enterprises generally face substantial risks such as high R&D investment, long development cycles, scarce resources, and a high probability of failure.

Although current regulatory regulations do not explicitly require companies to have completely independent sites and facilities, in actual regulatory practice, it is generally required that companies be equipped with "independently owned" production and testing sites, facilities, and other auxiliary facilities even during the research and development phase. This makes it difficult for small and medium-sized startups to focus limited resources on product development, prematurely burdening them with heavy assets or unnecessary human resource expenditures when the scientific research prospects are still unclear.

In recent years, the implementation of the registrant system has, to a certain extent, addressed the issue of resource allocation among medical device companies through contract manufacturing. However, it still cannot fully resolve the development challenges faced by small and micro enterprises in reducing operating costs and improving R&D efficiency during the research and development phase, especially for those小微企业 within the scope of the "List of Medical Devices Prohibited from Contract Manufacturing."By sharing resources during the R&D phase, limited resources can be utilized for innovation, promoting the early market entry of innovative products. Therefore, Changhua Chang proposed the following:

1. Establish and improve regulatory requirements: Clarify the allowance for site and facility resource sharing during the R&D phase of medical device products and establish basic conditions and requirements for sharing; improve the regulations, guidelines, and detailed rules that product registration system inspections are based on.

2. Implementation of the Main Responsibility of Medical Device Enterprises: Medical device enterprises should establish a quality management system in accordance with medical device regulatory laws, regulations, and the medical device production quality management standards, among other relevant requirements. They should identify and control risks associated with research and development activities conducted in shared spaces and assume primary responsibility. The quality management responsibilities for shared premises and facilities should be clarified through contracts (including quality agreements) or other means.

3. Implementation of a pilot mechanism for resource sharing of venues and facilities among different companies during the medical device R&D phase: The venues and facilities for sharing must meet the requirements of product development, such as cleanrooms of the same class and equivalent process water facility requirements.

4. Pilot first and gradually replicate and promote: It is recommended to pilot initially within a corporate group or a mature health industry park; regulatory authorities should actively explore ways to strengthen supervision, risk control, and optimize development, accumulate experience, and expand the application scope at an appropriate time.