Interpretation of Chinas New Policies on Medical Devices

Under the guidance of new ideas, the Food and Drug Administration issued some policies at the end of last year and the beginning of this year, coupled with the institutional reform of the State Council after the 12th National People's Congress and the transformation of government functions, including the transformation of medical device management institutions and functions, indicating the changes in medical device management ideas and policies.

The Office of the Food and Drug Administration issued a notice on March 20th soliciting opinions on the special approval procedures for innovative medical devices and simplifying the requirements for re registration application materials for medical devices, and also released two drafts for soliciting opinions. The purpose is to encourage research and innovation in medical devices, promote the reform of the medical device registration review and approval mechanism, improve the efficiency of medical device registration review and approval, and promote the development of the independent innovation medical device industry.

For the purpose of government regulation, the application of new technologies in the field of medical devices is to use better technologies for the health industry. How to make new technologies serve humanity as soon as possible under the legal framework is also a challenge faced by medical device managers in various countries. In 2002, the US FDA released a guiding document on the "principle of workload". The goal of the parliament is to simplify the registration process (i.e. reduce workload) to accelerate patients' access to breakthrough technologies This guiding document defines the principle of workload as "a successful approach to addressing pre-market issues that involves both industry and FDA optimizing time, effort, and resources appropriately." Some of the cases cited in this guiding document are also ones we have encountered during registration, such as clinical trial endpoints.

In response to the current speed of scientific and technological development and the continuous emergence of new medical device products, the US FDA proposed the "New Medical Product Critical Path Action Plan" and "Medical Device Innovation Action Plan" in 2004 and 2006 respectively to enable innovative medical devices to be used in human healthcare in a timely manner, promoting the rapid transformation of some new research results into products for public health. The "Special Approval Procedure for Innovative Medical Devices (Trial)" issued by the State Food and Drug Administration is aimed at providing a quick channel for the application of China's innovative independent core technologies in medical devices under the existing legal framework, prioritizing technical review, accelerating the registration process, and learning from the routine communication and exchange mechanism between the US FDA Center for Devices and Radiological Health (CDRH) and production enterprises. This is of great significance for promoting self innovation in medical devices and developing national industries. The "Special Approval Procedure for Innovative Medical Devices (Trial)" defines the objects entering the procedure, highlighting "independent intellectual property rights with core product technologies"; The principle of prioritizing the processing of innovative medical devices and strengthening communication and exchange with applicants has been clarified, based on the principles of early intervention, dedicated personnel, and scientific approval, without reducing standards or procedures; And provided specific measures for a fast track and a procedure for technical review.

The "Regulations on Simplifying the Application Materials for Re registration of Medical Devices (Trial)" released this time is a major reform in the registration process, aimed at addressing the current concerns about long registration cycles and excessive complexity. Previously, there was a change in the registered address, which took several years to review, including repeated testing and registration standards, as well as the review of instructions. Excessive government intervention not only increased the burden on enterprises, but also inadvertently exaggerated the limited responsibility of the government, which is not conducive to the development of the medical device industry. Simplifying some unnecessary review content is expected and in line with the current regulatory trend.

According to the "Plan for State Council Institutional Reform and Functional Transformation" and the "Notice of the State Council on Institutional Setting" approved by the 12th National People's Congress, the functions of China's medical device management institutions have undergone some changes, including the delegation of responsibilities to "provincial food and drug supervision and management departments for the certification of medical device quality management standards" and "provincial food and drug supervision and management departments for the application of administrative licensing for changes in the internal quality of domestically produced Class III medical devices that do not change the product". This is a change in the review responsibilities after simplifying the re registration review content mentioned above, which is more conducive to the construction of the registration review system.

In this functional transformation, the State Food and Drug Administration has established the Medical Device Registration Management Department and the Medical Device Supervision Department. The establishment of these two departments presents a clear regulatory approach. The government's supervision and management of medical devices is based on the node of "listing", and pre listing supervision includes the evaluation of whether the product meets the requirements of safety and effectiveness and whether it has the ability (quality system) to ensure long-term and stable safety and effectiveness performance, which is an evaluation of the applicant's ability. Post listing supervision includes daily (quality system) supervision of the enterprise and a series of subsequent market supervision (adverse events, advertising, operations, etc.). Two regulatory subsystems form a large system for medical device regulation. This is consistent with the regulatory approach of the Global Harmonisation of Medical Devices (GHTF) and in line with the current trend of medical device supervision and management.