CPPCC Member and MicroPort Medical Chairman Chang Zhaohua Urges Prompt Implementation of Post-Market Change Management Measures for Approved Medical Devices

Original Title: Chang Zhaohua, Chairman of MicroPort and Member of the National Committee of the Chinese People's Political Consultative Conference: Expedite the Introduction of Administrative Measures for Post-Approval Changes to Medical Device Products Source: China Securities Journal · CS.com.cn

China Securities Journal News (Reporter Fu Suying): During this year’s Two Sessions, Chang Zhaohua, a member of the National Committee of the Chinese People’s Political Consultative Conference and Chairman of MicroPort, proposed that administrative measures for post-approval changes to medical device products be introduced as soon as possible.

Chang Zhaohua stated that although the current Regulations on the Supervision and Administration of Medical Devices and the Measures for the Administration of Medical Device Registration basically meet the requirements of medical device enterprises and regulatory authorities, issues such as imperfect coordination and unclear definitions of product change types persist. These issues have led to confusion and deviations in understanding and implementation between enterprises and regulatory authorities, thereby somewhat weakening the comparative advantage of Chinese enterprises in international competition. Currently, the medical device regulatory systems in Europe and the United States have issued corresponding guidelines to guide enterprises in standardizing post-market change management, including relevant requirements and pathways for internal enterprise management and change submissions, as well as the responsibilities and timelines of regulatory authorities. To strengthen the overall competitiveness of China’s medical device enterprises, and against the backdrop of implementing the “four strictest” regulatory requirements for medical devices, it is recommended that relevant authorities promptly issue systematic guidance documents on the post-market change management of medical device products. This would further clarify and refine management processes and timelines, thereby enhancing the overall efficiency of the innovation chain in the medical device industry.

Chang Zhaohua put forward four suggestions. First, in reference to international standards, the national drug regulatory authorities should further clarify the regulations regarding post-approval changes for medical devices, clearly listing and defining the definitions and pathways for changes involving the medical device registrant, manufacturing site, production process, raw materials, labeling, packaging, etc. Drawing on the definitions of approval-based, filing-based, and reporting-based changes outlined in the Administrative Measures for Post-Approval Changes of Drugs, the responsibilities and management processes of drug regulatory authorities at all levels, as well as communication and consultation channels and timelines, should be clarified. Guideline documents such as principles for classifying medical device changes and a checklist of change items should also be developed.

Secondly, the national drug regulatory authorities have formulated laws and regulations to further clarify that medical device manufacturers are the responsible entities for managing changes to medical device products after their market approval. In accordance with the relevant requirements of medical device regulatory laws and regulations, medical device manufacturing enterprises shall establish a post-market change control system; determine the category of change management through comprehensive assessment based on product characteristics, and promptly submit declarations to the drug regulatory authorities; and enhance capabilities in internal quality management systems and post-market adverse event reporting, among other quality management activities.

Furthermore, drug regulatory authorities at all levels shall strengthen post-market supervision and management of changes implemented by medical device manufacturers, conduct spot checks on their change control practices, urge them to fulfill their responsibilities and demonstrate adequate capability in change management, and place emphasis on adverse event monitoring.

Finally, as drug regulatory authorities at all levels continue to improve the construction of regulatory frameworks and deepen institutional reforms, they should further strengthen the publicity and interpretation of regulations to ensure a unified understanding and consistent implementation among the departments involved in the “three-medical linkage” (medical care, health insurance, and pharmaceuticals). This will help reduce various barriers to market access for medical device products.