What Requirements should the Registrant under the Medical Device Registrant System Meet?

2022-04-07

Medical Device Registrant System

China first piloted the medical device registrant system in Shanghai Free Trade Zone in 2017. The pilot scope of the system has been expanded to 21 provinces (regions and cities) such as Shanghai, Guangdong, Tianjin, Beijing and Hunan in 2019.

The medical device registrant system separates the medical device registration certificate from the production license. The medical device registrant can entrust its registered products to one or more production enterprises that meet the requirements, so as to reduce the cost of medical device development, shorten the development cycle, integrate resources and improve resource utilization.

According to the notice of the NMPA on expanding the pilot work of medical device registrant system (gyjxz [2019] No. 33), the conditions for registrants are as follows:

（1）Enterprises and scientific research institutions participating in the pilot program whose domicile or production address is located in the provinces, autonomous regions and municipalities directly under the Central Government.

（2）Having full-time technical and management personnel related to regulatory affairs, quality management, post-marketing affairs, and have relevant knowledge and experience in medical device regulatory regulations and standards.

（3）Establishing a quality management system compatible with the product and maintain effective operation, with personnel to evaluate, audit and supervise the quality management system independently.

（4）Having the ability to take responsibility for the quality and safety of medical devices.

According to the requirements for medical device registrants in the implementation plan for the pilot work of medical device registrant system in Guangdong Province (2018):

(1) The residence is located within the jurisdiction of Guangzhou, Shenzhen and Zhuhai, which can be enterprises, R & D institutions and scientific researchers;

（2）It shall be equipped with full-time quality management personnel and relevant personnel for regulatory affairs and post listing affairs. The above personnel shall have corresponding professional background and work experience;

(3) Having the ability to manage the whole life cycle of medical devices, and having the personnel and conditions to evaluate, audit and supervise the quality management system;

（4）Having the ability to assume the responsibility for the quality and safety of medical devices, ensure that the development process is standardized, and all data are true, complete and traceable;

(5) Good quality and integrity, no record of dishonesty, and not included in the “blacklist” of food and drug supervision in Guangdong Province.

It can be seen from the above two documents that in the implementation plan of the pilot medical device registrant system, “scientists” (referring to scientific research institutions and corporate legal persons) are added to the registrants, and at the same time, the quality and integrity of the registrants are required.

Conditions for medical device registrants

2.2 Staffing requirements for registrants

Specific requirements for the basic staffing required by medical device registrants have been made in each pilot. For example, the “Guidelines for the Implementation of the Production Quality Management System for Medical Device Registrants in Guangdong Province (Trial) (No. 7 of 2018)” Organization and personnel requirements are as follows:

(1) A quality management system that is compatible with the product realization process should be established and maintained in effective operation, a management organization that is compatible with the quality management system process should be established, and an organizational chart should be established to clarify the responsibilities and authorities of each department and the quality management function.

(2) A manager representative should be identified, who is responsible for establishing, implementing and maintaining a quality management system covering the entire life cycle of medical devices, reporting the operation of the quality management system and improvement needs, and improving employees’ compliance with laws, regulations and customers.

(3) Full time R & D technicians shall be equipped to be familiar with the R & D and technology of the registered medical device products, with corresponding professional background and work experience, so as to ensure that the research materials and clinical data submitted are true, complete and traceable.

(4) Full time quality management personnel shall be provided, who shall have working experience, be familiar with the production quality management requirements of the registered medical device products, and be able to evaluate, audit and supervise the quality management system of the registrant and the trustee.

(5) It shall be equipped with full-time legal affairs personnel, who shall have working experience, be familiar with the legal requirements of the registered medical device products, and be able to handle relevant legal affairs.

(6) Full time post market affairs personnel shall be provided, who shall have working experience, be familiar with the requirements of adverse event monitoring, product recall and after-sales service of medical devices, and be able to handle relevant post market affairs.

According to the above requirements, the medical device registrant should be equipped with at least 1 management agent, 1-2 R & D technical personnel, 1-2 quality management personnel, 1 legal affairs personnel, and 1 post-market affairs personnel. therefore, at least 7-8 people are needed to meet the requirements of the registrant.

In addition, these personnel also need to have relevant professional knowledge and work experience, which will be the focus of the drug regulatory department during the review.

2.3 Legal responsibilities and obligations of registrants

The registrants and recorders of medical devices shall strengthen the quality management of the whole life cycle of medical devices and be responsible for the safety, effectiveness and quality controllability of medical devices in the whole process of development, production, operation and use according to law.The registrant and recorder of medical devices shall perform the following obligations:

(1) Establishing a quality management system suitable for products and maintain effective operation;

(2) Formulating post listing research and risk control plans and ensure their effective implementation;

(3) Carrying out adverse event monitoring and re- evaluation according to law;

(4) Establish and implement product traceability and recall system;

(5) Other obligations stipulated by the drug regulatory department under the State Council.

Medical device registrant system and medical device CDMO

The implementation of the medical device registrant system can not only separate the medical device registration certificate from the production license, but also realize the entrusted production of medical devices. At the same time, the R & D of medical devices can also be entrusted,For example, in the Guidelines for the Implementation of the Production Quality Management System of Medical Device Registrants in Guangdong Province (Trial) (No. 7, 2018), the requirements for the R & D of medical devices are as follows:

(1) Those who research and develop medical device products by themselves shall have corresponding research and development sites, facilities and equipment.

(2) If entrusting the research and development of medical device products, it shall ensure that the entrusted institution has the corresponding research and development sites, facilities and equipment.

The promotion of medical device registrant system will promote the upstream extension of device outsourcing services. The implementation of the medical device registrant system provides a condition: the device cro can extend to the upstream cdmo (contract R & D and production organization), and can intervene in innovation projects at an earlier stage to help researchers and clinicians better output compliant products, so as to provide greater value. In the R & D and production of medical devices, device enterprises can entrust third-party service institutions to carry out R & D or production, so as to improve the utilization of resources.

Source：Beo Biomedical Materials

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