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:
(2) Obligations and responsibilities
Under the Medical Device Holder Regime, the Commissioned Enterprise shall:
fulfill all the obligations under the Regulations on Supervision and Administration of Medical Devices and other relevant laws and regulations, the commissioning agreement, quality agreement and bear all the liabilities thereof;
manufacture the products according to the relevant laws and regulations of medical device, commissioning agreement, quality agreement, and shall be responsible for the quality of products towards Medical Device Holder;
report timely serious quality accident of medical devices released to the market;
apply for the reduction of commissioned products with the authorities after the relevant commissioned production is terminated; and
not delegate the commissioned work to any third party.
c) Relevant Procedures
(1) Application of registration for the Medical Device Registration Certificate
The Medical Device Holder shall apply for the Medical Device Registration Certificate with the relevant drug administration and supervision authority. The Medical Device Registration Certificate shall indicate the name of the Commissioned Enterprise.
(2) Application for manufacture license of the medical device
In case the Commissioned Enterprise does not have the relevant capacity of production, such enterprise shall first make i) an application for the medical device manufacture license (“Manufacture License”) or ii) the change of its Manufacturing License, by submitting the Medical Device Registration Certificate of Medical Device Holder to the competent drug administration and supervision authority.
(3) Application for change of address indicated on the Medical Device Registration Certificate
In case the Medical Device Holder wishes to change the manufacturing address indicated on its current Medical Device Registration Certificate through the Medical Device Holder Regime, the applicant shall carry out the following steps of application:
First step: Commissioned Enterprise and Medical Device Holder shall jointly make the application to the drug administration and supervision authority at provincial level to conduct the onsite inspection;
Second step: Commissioned Enterprise shall make the application for the change of its Manufacturing License;
Third step: The Medical Device Holder shall submit the modified Manufacturing License according to the above step and the commissioning agreement to the relevant drug administration and supervision authority for the change of its current Medical Device Registration Certificate regarding the manufacturing address.
(4) Recordal of commissioning production by Commissioned Enterprise
Commissioned Enterprise shall make the recordal to the competent drug administration supervision authority at the provincial level by submitting the commissioning agreement, quality agreement and other documents required for the commissioning production.
1 The three implementation plans include the Implementation Plan of Pilot Regime of Medical Device Holder within China (Shanghai) Pilot Free Trade Zone dated December 1, 2017, the Implementation Plan of Pilot Regime of Medical Device Holder of Guangdong Province dated August 20, 2018 and the Implementation Plan of Pilot Regime of Medical Device Holder within China (Tianjin) Pilot Free Trade Zone dated August 24, 2018.
2 Announcement of the Publication of List of Medical Devices Prohibited Commissioning Production dated September 26, 2014. The medical devices prohibited from commissioning production mainly refer to the medical devices which are considered as difficult to control the quality during the production, and important to the human health, such as artificial organ medical device, implants material and etc.