On 18 March 2021, the National Medical Products Administration issued the revised version of the Regulations on the Supervision and Administration of Medical Devices. The main contents of the revision include:

 

  1. Medical devices are divided into three management categories from low risk to high risk. The current classified management system of medical device regulation is not satisfactory enough, especially for high-risk products; while for low-risk products, the supervision is too strict, which puts a heavy burden on enterprises. At the same time, the current regulations for enterprises on production and management requirements are simple, and their responsibility is not specific. There are also phenomena such as more attention being paid to product approval rather than process supervision.

 

Therefore, to address such problems, the Regulations stipulate that the product classification catalogue should be timely adjusted according to the production, operation and use of medical devices, as well as the analysis and evaluation of product risk changes. In addition, when formulating and adjusting the catalogue, efforts should be made to listen to the opinions and feedback of production and operation enterprises, users and industrial organizations, at the same time referring to the practice of international classification of medical devices. Concerning the management categories of medical devices, the category I for low-risk devices implements product registration management, category II medical devices are subject to the approval from provincial-level food and drug regulatory authorities, while category III devices are subject to product registration management by the National Medical Products Administration. The revised Regulations points out to release the operation of medical devices in category I, implement archival management for the operation of medical devices in category II, and implement licensing management for the operation of medical devices in category III.

 

  1. Medical device production and operation enterprises shall submit regular self-inspection reports. According to the Regulations, enterprises are required to establish, maintain and improve quality management systems also to cover product design and development, raw material procurement, production process control etc., and submit regular self-inspection reports. According to the Regulations, a system for purchase inspection and sales records should be established: the enterprise and the specific department using the device(s) should verify the qualification of the supplier and the certificate of product qualification, and then record them into the system. Category II medical device wholesale enterprises and Category III medical device trading enterprises shall also establish sales records. In addition, the Regulations adds medical device safety management obligations to users, such as strengthening the technical training of staff to ensure the use of medical devices in accordance with product specifications, technical operation specifications and other requirements. It also clarifies the storage place suitable for the type and quantity of the medical devices in use and carry out the care and maintenance work for large-scale medical devices.

 

  1. Medical devices that can be reused in a safe and effective way, will not be included in the catalogue of disposable use devices. In practice, however, there are problems such as the range of disposable medical devices being too wide, and many duplicates, especially for high-value medical consumable products; these greatly increase the medical costs as well as the burden on patients. Therefore, the Regulations stipulate that the research and development of medical devices should follow the principles of safety, effectiveness, and frugality, and require the implementation of catalogue management on this basis. More specifically, the Regulations require that (i) the catalogue of disposable medical devices should be formulated, adjusted and published by the National Medical Products Administration and the National Health Commission of the People’s Republic of China; (ii) medical devices that can be reused in a safe and effective way, shall not be included in the catalogue of disposable medical devices; (iii) for medical devices that are safe and effective after repeated use, due to improvement in design, production process, disinfection and sterilization technology, etc., the list of disposable medical devices shall be adjusted. This change introduced by the revised Regulations can ensure that part of disposable medical devices can be reused on the premise of safety and effectiveness.

 

  1. In view of the common practice of focusing more on examination and approval rather than supervision, as well as the lack of efficiency and means in the supervision of medical devices, the Regulations strengthen the routine supervision and add more supervision means. They also add a monitoring system, reevaluation system of registered medical device, and a medical device recall system, etc.

 

In line with the Regulations on the Supervision and Administration of Medical Devices, the Regulations on the Registration of Medical Devices was also revised. From 26 March to 25 April 2021, NMPA called for public comments on the revised document. Compared with the previous version, the main changes introduced include:

 

  1. The requirements of the examination report for category II and III medical devices are adjusted. The examination report of the medical device can be issued through self-testing by the applicant or issued by a qualified medical device examination institution.

 

  1. The requirements of certification documents for overseas listing of innovative medical devices are adjusted. In the past, all overseas medical devices needed to submit overseas listing certification documents, while the revised Regulations removed this requirement for innovative medical devices that did not list overseas.

 

  1. Implement the system of medical device registrant and recorder. Registrants and recorders of medical devices should strengthen the whole cycle management of medical devices. They are responsible for ensuring the safety, effectiveness and quality control of medical devices in the whole process of development, production, operation and use. If the production of medical devices is commissioned, the registrant and recorders shall strengthen the management of the production behavior of the commissioned enterprise, supervise its production in accordance with the requirements, and be responsible for the quality of the commissioned production of medical devices. Furthermore, the original requirement that non-innovative medical devices shall not be commissioned for production was removed in the revised Regulations.

 

  1. The relevant requirements of clinical evaluation and clinical trial were adjusted. The clinical evaluation of medical equipment will be carried out based on the product characteristics, clinical risk, clinical data etc. By analyzing clinical data of a certain kind of device or by conducting clinical trials, the safety and effectiveness of medical devices can be clearly proved. Besides, there are also situations that the clinical evaluation data is not required to submit.

 

  1. The requirements for conditional approval were adjusted. Medical devices that are urgently needed for rare diseases, serious life-threatening disease without effective treatment, or for responding to public health crises, the pharmaceutical supervisory and administrative department can make a conditional approval, clearly indicating the validity period as well as the work needed to be completed after listing.

 

  1. Specification requirements were added. The applicant shall prepare the product specification of the medical device to be registered. The product specification approved by the registration examination shall be issued to the applicant in the form of attachment to the medical device registration certificate. The listed medical device should be consistent with the specification approved by the registration.

 

  1. The requirements for changing registration information were adjusted, while new ones were added for changes of the specifications. The revised Regulations clarify that the medicine regulatory department should organize the quality management system verification when necessary for conducting the technical evaluation on the change of the licenses.

 

  1. Relevant contents of clinical trial management were added. The revised Regulations clarify that medicine regulatory departments can suspend or terminate the clinical trial, in the event of large-scale and unexpected serious situations in clinical trials, or evidence of serious quality problems of experimental medical devices. It is clarified that the medicine regulatory departments may conduct on-site inspection of the clinical trial, if necessary. Provincial-level medicine regulatory departments shall organize supervision and inspection over clinical trial institutions registered within their jurisdiction.