On May 14, the National Medical Products Administration convened a summary meeting on pilot work of medical device registrant system in Shanghai. At this Meeting, the experience in the pilot work of medical device registrant system in China since 2017 was summarized and exchanged; and the relevant requirements for fully implementing the medical device registrant and filing applicant system were studied and deployed. Xu Jinghe, the Deputy Director of the National Medical Products Administration, attended the meeting and made a speech.
The medical device registrant and filing applicant system is a basic system that runs through the whole life cycle of medical devices, and is also an important measure for China to deeply implement the reform of medical device review and approval system. After the newly revised Regulations for the Supervision and Administration of Medical Devices came into effect on June 1 this year, the medical device registrant and filing applicant system will be implemented nationwide as the core system of medical device supervision. At the meeting, Shanghai, Guangdong and Tianjin Municipal Medical Products Administrations reported and exchanged their experience in the pilot work of the registrant system; relevant pilot enterprises introduced the conditions of performing the obligations of the registrant; Medical Device Registration Department and Medical Device Regulation Department summarized the pilot work of registrant and introduced the working idea of fully implementing the registrant and filing applicant system.
The meeting fully recognized the remarkable achievements made in the pilot work of medical device registrant system. In March 2017, the State Council printed and issued the Plan for Comprehensively Deepening the Reform and Opening-up of the China (Shanghai) Pilot Free Trade Zone to allow medical device registration applicants in the Shanghai Pilot Free Trade Zone to entrust medical device manufacturers in Shanghai to produce their products. In December the same year, Shanghai started the pilot work of medical device registrant system. In May 2018, Guangdong and Tianjin Pilot Free Trade Zones initiated the pilot work successively. In 2019, the National Medical Products Administration expanded the pilot work of the medical device registrant system to 22 provinces (autonomous regions and municipalities). By the end of April this year, a total of 1,341 products in pilot provinces have been approved for marketing according to the pilot work of the medical device registrant system. The pilot work has further perfected the regulation system fully implemented by registrants, has made their main responsibilities clearer, has further improved the cross-regional supervisory coordination mechanism, has further improved the allocation of industrial resources, has further accelerated the transformation of scientific research achievements, and has further promoted the innovative development of the medical device industry.
According to Xu Jinghe, the full implementation of the medical device registrant and filing applicant system is the core content of the newly-revised Regulations and is also an important measure to promote the innovative development and high-quality development of the medical device industry. All regions should profoundly realize the significance of the full implementation of the registrant and filing application, scientifically grasp the relation of rights and obligations between registrants and entrustees and the legal relation between cross-regional collaborative supervision departments, and effectively strengthen the post-marketing supervision under the medical device registrant and filing applicant system to ensure the full implementation of the registration and filing applicant system.
Xu Jinghe emphasized that we should accelerate the formulation of relevant supportive documents to guide enterprises to do a good job in entrusted production under the system of registrant and filing applicant and other work; we should intensify efforts to publicize and implement the new Regulations to make registrants and file applicants keep the new requirements in mind and effectively perform their main responsibilities throughout the life cycle; we should also do a good job in information collection and sharing to ensure that the cross-regional supervision information is unobstructed and form collaborative supervision; in addition, we should conscientiously implement the implementation opinions of the General Office of the State Council on fully strengthening the capacity building of drug supervision to further improve the capacity and level of medical device supervision.
The relevant departments and directly affiliated units of the National Medical Products Administration, the relevant responsible persons and personnel concerned from the medical products administration s of the 22 provinces (autonomous regions and municipalities) involved in the pilot work, as well as some experts and representatives of relevant enterprises attended this Meeting.
Source: China Pharmaceutical News
The medical device registrant and filing applicant system is a basic system that runs through the whole life cycle of medical devices, and is also an important measure for China to deeply implement the reform of medical device review and approval system. After the newly revised Regulations for the Supervision and Administration of Medical Devices came into effect on June 1 this year, the medical device registrant and filing applicant system will be implemented nationwide as the core system of medical device supervision. At the meeting, Shanghai, Guangdong and Tianjin Municipal Medical Products Administrations reported and exchanged their experience in the pilot work of the registrant system; relevant pilot enterprises introduced the conditions of performing the obligations of the registrant; Medical Device Registration Department and Medical Device Regulation Department summarized the pilot work of registrant and introduced the working idea of fully implementing the registrant and filing applicant system.
The meeting fully recognized the remarkable achievements made in the pilot work of medical device registrant system. In March 2017, the State Council printed and issued the Plan for Comprehensively Deepening the Reform and Opening-up of the China (Shanghai) Pilot Free Trade Zone to allow medical device registration applicants in the Shanghai Pilot Free Trade Zone to entrust medical device manufacturers in Shanghai to produce their products. In December the same year, Shanghai started the pilot work of medical device registrant system. In May 2018, Guangdong and Tianjin Pilot Free Trade Zones initiated the pilot work successively. In 2019, the National Medical Products Administration expanded the pilot work of the medical device registrant system to 22 provinces (autonomous regions and municipalities). By the end of April this year, a total of 1,341 products in pilot provinces have been approved for marketing according to the pilot work of the medical device registrant system. The pilot work has further perfected the regulation system fully implemented by registrants, has made their main responsibilities clearer, has further improved the cross-regional supervisory coordination mechanism, has further improved the allocation of industrial resources, has further accelerated the transformation of scientific research achievements, and has further promoted the innovative development of the medical device industry.
According to Xu Jinghe, the full implementation of the medical device registrant and filing applicant system is the core content of the newly-revised Regulations and is also an important measure to promote the innovative development and high-quality development of the medical device industry. All regions should profoundly realize the significance of the full implementation of the registrant and filing application, scientifically grasp the relation of rights and obligations between registrants and entrustees and the legal relation between cross-regional collaborative supervision departments, and effectively strengthen the post-marketing supervision under the medical device registrant and filing applicant system to ensure the full implementation of the registration and filing applicant system.
Xu Jinghe emphasized that we should accelerate the formulation of relevant supportive documents to guide enterprises to do a good job in entrusted production under the system of registrant and filing applicant and other work; we should intensify efforts to publicize and implement the new Regulations to make registrants and file applicants keep the new requirements in mind and effectively perform their main responsibilities throughout the life cycle; we should also do a good job in information collection and sharing to ensure that the cross-regional supervision information is unobstructed and form collaborative supervision; in addition, we should conscientiously implement the implementation opinions of the General Office of the State Council on fully strengthening the capacity building of drug supervision to further improve the capacity and level of medical device supervision.
The relevant departments and directly affiliated units of the National Medical Products Administration, the relevant responsible persons and personnel concerned from the medical products administration s of the 22 provinces (autonomous regions and municipalities) involved in the pilot work, as well as some experts and representatives of relevant enterprises attended this Meeting.
Source: China Pharmaceutical News