The National Medical Products Administration (the “NMPA”) promulgated the Notice of National Medical Products Administration regarding the Extension of Pilot Regime of Medical Device Holder on August 1, 2019 (the “Notice”).
This Notice is aimed at further enhancing the reform of medical devices holder regime which was promulgated by the Chinese authorities in 2017 and 2018.
Following the Opinions on Deepening the Reform of the Evaluation and Approval System and Inspiring Innovation of Drugs and Medical Devices promulgated by Central Committee of the Communist Party of China and General Office of the State Council on October 8, 2017, the pilot regime of medical device holder (the “Medical Device Holder Regime”) has been implemented in Shanghai, Guangdong and Tianjin according to the implementation plans1 of each of these pilot areas (jointly as “Implementation Plans”).
Based on the Implementation Plans, the applicant of the medical device holder located in the pilot area can apply for the Medical Device Registration Certificate (the “Medical Device Holder”) for class 2 and class 3 medical devices (excluding the medical devices listed in the List of Medical Devices Prohibited Commissioning Production2 (the “List”)) by commissioning another manufacturing enterprise which is also located in the pilot area to manufacture its registered medical device (the “Commissioned Enterprise”).
The Notice further extends and clarifies the pilot regime based on the Implementation Plans as follows:
1. Extension of pilot areas
According to the Notice, the pilot area of Medical Device Holder Regime shall be extended from three into twenty-one cities and provinces, including Beijing, Tianjin, Hebei, Liaoning, Heilongjiang, Shanghai, Jiangsu, Zhejiang, Anhui, Fujian, Shandong, Henan, Hubei, Hunan, Guangdong, Guangxi, Hainan, Chongqing, Sichuan, Yunnan, Shanxi.
In addition, the Notice allows the applications amongst different pilot areas, i.e., the Medical Device Holder and the Commissioned Enterprise can be located in different pilot areas.
2. Conditions, Obligations and Responsibilities of Medical Device Holder and Commissioned Enterprise
The Notice further clarifies the conditions, obligations and responsibilities of Medical Device Holder and Commissioned Enterprise.
a) Medical Device Holder
According to the Notice, the applicant of the Medical Device Registration Certificate can mandate a Commissioned Enterprise to manufacture the samples, and the holder of the Medical Device Registration Certificate can mandate the Commissioned Enterprise to manufacture the medical device under its Medical Device Registration Certificate. The Medical Device Holder shall meet the following conditions:
- it is a manufacturing company whose registered address or manufacturing premise is located in one of the pilot areas, or a research institution is located in one of the pilot areas;
- it has technical staffs and management personals who have the professional knowledge regarding the legal issues, quality management, post marketing issues, as well as the relevant knowledge regarding the regulatory requirements and standard of medical device;
- it has set up a quality management system; and
- it has the capacity of undertaking the quality safety responsibility of medical device.
(2) Obligations and responsibilities
Under the Medical Device Holder Regime, the Medical Device Holder shall:
- be responsible for the research and development, clinical trial, manufacturing, distribution, logistic, aftersales, product recall, adverse event reporting;
- execute the commissioning agreement and quality agreement with Commissioned Enterprise;
- be responsible for the supervision of Commissioned Enterprise;
- be in charge of adverse event monitoring and product tracking;
- have the right to distribute the medical device by itself or mandate other qualified medical device trading enterprise to distribute its products. In the latter case, the Medical Device Holder shall conclude a relevant commissioning agreement with the medical device trading enterprise;
- track all the procedure of research and development, manufacture, distribution and adverse event by information means; and
- guarantee that the research material and clinical trial data is true, accurate, systemically complete and trackable.
b) Commissioned Enterprise
To act as the Commissioned Enterprise, it shall:
- be a manufacturing company whose registered address or manufacturing premise is located in one of the pilot areas;
- have the relevant quality management system and capacity of production.
(2) Obligations and responsibilities
Under the Medical Device Holder Regime, the Commissioned Enterprise shall:
c) Relevant Procedures
(1) Application of registration for the Medical Device Registration Certificate