A few days ago, the 'Decision of the State Council on Amending the Regulations on the Supervision and Administration of Medical Devices' (the 'Decision') was released. The 'Decision' revised the 'Regulations on the Supervision and Administration of Medical Devices', and the revised Regulations on the Supervision and Administration of Medical Devices further refined and clarified the duties of the regulatory authorities, which specifically increased the supervision of large medical equipment and prevented large-scale Over-examination, over-treatment, etc. related to medical equipment.

The main basis for the supervision of medical devices in China is the Regulations on the Supervision and Administration of Medical Devices. From the revised Regulations on the Supervision and Administration of Medical Devices, the state hopes to encourage the research and development and innovation of medical devices and promote the promotion and application of new medical device technologies. Strengthen the supervision of medical devices.

With the 'China Made 2025' and 'Healthy China 2030' as a national strategy, the innovation and development of medical devices have received much attention. The medical device industry covers many fields of medicine, machinery, electronics, etc. Its core technologies cover medical polymer materials, laboratory medicine, hematology, life sciences, etc. It is a multidisciplinary, capital-intensive high-tech industry, which is a global The focus of large enterprises competing for competition is also an important indicator for measuring the comprehensive strength of a country and the level of scientific and technological development.

In recent years, China's medical device industry has continued to develop rapidly, and the new “three big pieces” of X-ray machines, ultrasound, biochemistry and other new layers have been upgraded, and high-end products such as MRI, color ultrasound, CT and Patt CT have been successfully localized. Data show that in 2001, China's medical device market was only 17 billion yuan, and exceeded 100 billion yuan by 2015. In 15 years, the market scale has surged more than 15 times, and the average annual growth rate has exceeded 20%, much higher than the growth rate of GDP.

But unfortunately, China's medical equipment key components lack core technology, large equipment still relies on imports, and the multinational companies such as GE, Philips, and Siemens, which are known as 'GPS' in the industry, have long monopolized China's medical device market. The reasons for the above phenomena are very complicated, and there are many factors such as technology and market. However, it is unavoidable that improper regulatory policies have affected the innovation and development of medical devices in China to a certain extent. For example, the time-consuming registration of medical devices, the unclear approval criteria, the tedious part of the links, and the sluggish price review have led to a long period of time for some domestic enterprises to enter new clinical applications and new technologies.

In response to problems in the examination and approval of drugs and medical devices, the State Council issued the 'Opinions on Reforming the Examination and Approval System for Drugs and Medical Devices' in August 2015. Since then, the reform of the examination and approval system for drugs and medical devices has begun to accelerate. A series of policies was introduced. For example, in March 2016, the State Food and Drug Administration and the National Health and Family Planning Commission jointly issued the “Quality Management Regulations for Clinical Instruments Clinical Trials”. In October 2016, the State Food and Drug Administration issued the “Priority Approval Procedure for Medical Devices”, which included products that met the national science and technology major projects and clinical emergency needs into the priority approval channel.

Recently, the State Food and Drug Administration has issued four consecutive policies to speed up the review and approval of clinically urgently needed drugs and medical devices, and encourage domestic medical devices to replace imports. These four policies include 'Related Policies on Encouraging Drugs, Medical Device Innovation, Accelerating the Examination and Approval of New Drugs and Medical Devices,' (Draft for Comment), 'Related Policies for Encouraging Drugs, Medical Device Innovation, and Reforming Clinical Trial Management' (Consultation Draft), Relevant Policies on Encouraging Drugs, Medical Device Innovation, Implementing Life Cycle Management of Drugs and Medical Devices (Draft for Comment) and Relevant Policies on Encouraging Drugs, Medical Device Innovation, and Protecting Innovators' Rights and Interests (Consultation Draft).

The contents of the four policies include accelerating the examination and approval of clinically urgently needed drugs and medical devices; and implementing the record-keeping system management for clinical trial institutions. If there is no response within 60 working days after the acceptance of the clinical trial application, clinical trials can be carried out according to the submitted plan; Accept the data of overseas clinical trials; implement the system of listing license holders in the national drug and medical device license (registration) and improve the drug test data protection system.

It is worth mentioning that at present, a series of regulatory reforms for medical devices involve not only registration, approval, clinical trials, but also the use of links. The 'Decision' requires that the health and family planning department should supervise and evaluate the use of large-scale medical equipment; if it finds illegal use and excessive inspection and over-treatment related to large-scale medical equipment, it should be immediately corrected and dealt with according to law.

It is foreseeable that these regulatory reform measures will speed up the registration and approval of medical devices, which will be beneficial to the innovative development of the medical device industry, help to break the dependence of large medical equipment on foreign imports, and strengthen the supervision of medical device use to ensure medical devices. The rational use of science and prevention of public medical institutions, after the abolition of 'medicine-based medicine,' then turned to over-examination, over-treatment of 'medical training.'