National Medical Products Administration: Expanding the pilot program for the medical device registration holder system

According to the National Medical Products Administration8month1According to a press release on the day, in order to thoroughly implement the "Opinions on Deepening the Reform of the Review and Approval System and Encouraging Innovation in Drugs and Medical Devices" (Document No. [厅字〔2017〕42No.) issued by the General Office of the Central Committee of the Communist Party of China and the General Office of the State Council, accelerate the innovative development of the medical device industry, and on the basis of the pilot work of the medical device registration holder system conducted in the Shanghai, Guangdong, and Tianjin pilot free trade zones, today, the National Medical Products Administration (hereinafter referred to as the National Administration) issued the "Notice on Expanding the Pilot Work of the Medical Device Registration Holder System" (National Medical Products Administration [械注〔2019〕33No., hereinafter referred to as the "Notice"), further expanding the pilot program of the medical device registration holder system to further accumulate experience for the comprehensive implementation of the medical device registration holder system.

The Notice clarifies that Beijing, Tianjin, Hebei, Liaoning, Heilongjiang, Shanghai, Jiangsu, Zhejiang, Anhui, Fujian, Shandong, Henan, Hubei, Hunan, Guangdong, Guangxi, Hainan, Chongqing, Sichuan, Yunnan, and Shaanxi21provinces, autonomous regions, and municipalities directly under the Central Government will participate in this pilot program of the medical device registration holder system.

The Notice specifies the corresponding conditions and obligations and responsibilities for the registrants and entrusted manufacturers participating in the pilot program, clarifying that both parties should sign entrustment contracts and quality agreements, and specifying the procedures for product registration, changes, and production enterprise license processing. It also emphasizes that all levels of drug regulatory departments should strengthen the supervision and management of the registrants' fulfillment of their obligations, including ensuring the quality of medical devices, marketing and services, monitoring and evaluation of adverse events, and recalls. For entrusted production involving cross-regional operations, relevant provincial drug regulatory departments should, on the basis of coordination and consistency, determine the division of responsibilities for cross-regional supervision, implement the main body of daily supervision, and ensure seamless and comprehensive supervision of the entire life cycle and chain of medical devices.

The National Administration's expansion of the pilot program of the medical device registration holder system aims to further explore the establishment of a medical device registration holder system and an entrusted production management system, optimize resource allocation, and implement the main responsibilities; explore the establishment of a sound medical device quality management system for registrants, clarify the legal relationship between the main bodies such as medical device registrants and entrusted manufacturers, and on the basis of clear responsibilities and controllable risks, build a quality management system and system for the entire life cycle of registrants; explore innovative ways of regulating medical devices and effectively implement"Supervisory work must keep up"requirements, further release industrial vitality, promote high-quality development of the medical device industry, and meet the needs of the people for high-level medical devices.