CPPCC Standing Committee Member Chang Zhaohua Proposes Enhancing Technical Review Standards for Class II Medical Devices to Foster Industry Innovation

China Food and Drug News: In 2021, the revised "Regulations on the Supervision and Administration of Medical Devices" was released and implemented. A series of supporting rules and regulations, such as the "Measures for the Registration and Filing of Medical Devices," and operational guidelines were successively issued.Innovative HealthcarePreliminary results have been achieved in innovative reform initiatives such as special approval for devices, the medical device registrant system, and pilot reform programs in key areas. To promote the innovative development of China's medical device companies, during this year's Two Sessions in China, Chang Zhaohua, a member of the National Committee of the Chinese People's Political Consultative Conference (CPPCC) and Chairman and CEO of Shanghai MicroPort Medical (Group) Co., Ltd., submitted three proposals. He suggested further improving the technical review process for Class II medical device registration, unifying evaluation standards, and enhancing the quality and efficiency of the review process. Additionally, he proposed recommendations on encouraging resource sharing during the research and development phase of medical device companies and promoting cross-administrative region allocation of production resources for these companies.

Unify the technical review scale and review standards as soon as possible.

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 positive results. At the same time, drug regulatory authorities in multiple regions, including Zhejiang, Guangdong, Shandong, Tibet, Shanghai, Hunan, Shaanxi, and Jiangsu, introduced "Special Review Procedures for Innovative Class II Medical Device Products," promoting the development of the medical device industry. "However, due to certain differences in the knowledge structure, professional expertise, and comprehensive judgment capabilities of reviewers across regions, there are variations in focus and inconsistent standards when different provinces and cities review the same type of product," said committee member Chang Zhaohua. He noted that the lack of unified review standards has caused some confusion for companies and affected the efficiency and quality of reviews, as well as the control over the safety and effectiveness of Class II medical devices.

To this end, he suggested that medical device technology evaluation agencies in various regions of China can promote, refer to, or directly follow the quality management system of the Center for Medical Device Evaluation of the National Medical Products Administration (NMPA). This will continuously improve the workflow for the technical evaluation of Class II medical devices and ensure the quality of technical reviews. Efforts should also be accelerated to introduce more guidance principles for the technical evaluation of Class II medical devices, unifying the standards for evaluating the same type of product across different regions to reduce inconsistencies caused by individual reviewers' cognitive and interpretative differences. Additionally, it is crucial to strengthen the professional development of review teams nationwide and enhance the technical competency of reviewers.

Chang Zhaohua, a member of the committee, suggested that the informatization of technical review in various regions should be promoted to increase transparency. Electronic submission of registration materials for Class II medical devices should be encouraged. For Class II medical devices approved through innovative, priority, or special approval procedures, it is recommended that their technical review reports be disclosed nationwide. A consultation and reconsideration mechanism should be established to enhance communication, exchange, and collaboration among reviewers across the country.

Encourage Resource Sharing in the R&D Stage

High R&D investment, long development cycles, scarce resources, and a high probability of failure are common challenges faced by many small and medium-sized medical device enterprises. "Although current regulatory laws do not explicitly require companies to have completely independent facilities, in actual regulatory practice, companies are generally required to equip 'independently owned' production and testing sites, facilities, and other auxiliary resources even during the R&D stage," said Standing Committee Member Chang Zhaohua. "This makes it difficult for startups and small businesses to focus limited resources on product development, burdening them prematurely with heavy assets or unnecessary human resource expenditures when the scientific prospects are still unclear." With the implementation of the Marketing Authorization Holder (MAH) system, entrusting production to third parties has, to some extent, addressed the issue of resource allocation among medical device companies. However, it still does not fully resolve the operational cost and low R&D efficiency challenges faced by small businesses, especially micro-enterprises within the scope of the "List of Medical Devices Prohibited from Entrusted Production," during their R&D phase.

How to effectively help companies "reduce burdens"? Committee member Chang Zhaohua suggests that companies can share premises and facilities during the R&D phase, allowing limited resources to be used in innovation, thereby stimulating corporate creativity.

First, establish and improve regulatory requirements, clarify the permission for medical device products to share venues and facility resources during the R&D phase, and set basic conditions and requirements for sharing. Improve the regulations, guidelines, and detailed rules that form the basis of product registration system inspections. Second, medical device companies should establish a quality management system in accordance with laws, regulations, and standards, identify and control risks associated with R&D activities conducted in shared spaces, and assume primary responsibility. The quality management responsibilities for shared venues and facilities should be clearly defined through contracts or other means.

"On the basis of clarifying regulatory requirements and implementing the main responsibilities, a pilot mechanism for resource sharing of venues and facilities among different enterprises during the R&D phase of medical devices should be promoted, ensuring that the shared venues and facilities are suitable for the product development needs." Committee member Chang Zhaohua suggested that this could initially be piloted within group companies or established health industry parks, and then gradually replicated and expanded. Regulatory authorities should actively explore ways to strengthen supervision, risk control, and optimize development, accumulating experience and expanding the application scope at an appropriate time.

Promote Enterprises to Allocate Production Resources Across Administrative Regions

Medical Device Industry Regional Integration Helps Form Specialized, Large-Scale National and Regional Medical Device Industry Clusters, Achieving Better Resource Optimization. "However, under current regulations, medical device companies establishing new production sites across administrative regions are still required to set up new companies locally, reapply for product registration, and then apply for a manufacturing license. This limits the ability of medical device companies to allocate production resources across administrative regions," noted Committee Member Chang Zhaohua. He believes that keeping the responsible entity of medical device companies unchanged while allowing them to allocate production resources across administrative regions is more conducive to maintaining the consistency and continuity of quality management systems, reinforcing the primary responsibility of registrants for lifecycle quality management.

To this end, he suggested accelerating the implementation of relevant policies and regulations to allow medical device companies to add production sites across administrative regions (provinces, autonomous regions, and municipalities) while keeping the main production license unchanged. The process should clearly define a closed-loop procedure for "application-acceptance-approval-post-certification supervision." At the same time, establish cross-regional communication and supervision mechanisms, clarify information sharing between regional regulatory bodies, further deepen regional regulatory collaboration, and promote mutual recognition of inspection results among medical device companies. Additionally, create a unified national database and comprehensive supervision platform for the medical device industry, using IT and digital tools to achieve interconnectivity of data across different levels of medical device regulatory authorities, ensuring high-quality and efficient oversight. (Xu Mingshuang)

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(Editor: Zhang Kexin)