In recent years, although China has a lot of technical research results in the medical device industry , there are also many negative incidents related to medical devices, which has attracted the attention of many people from all walks of life. The occurrence of these tragedies also warns the society that the stable quality of medical device products is still a very prominent regulatory issue.
There are three shortcomings in China's medical device supervision:
One: the regulatory basis is not strong enough
From the perspective of industrial quality, since the reform and opening up, all localities have been competing for the production and operation of medical equipment , forming a regional medical device industry layout that is “small but complete.†In addition to the lack of industrial policies, China's medical device enterprises have a large number, small scale, scattered distribution, low degree of intensification, and insufficient quality and safety management capabilities. According to statistics, there are currently 13,876 medical device manufacturers and 140,000 operating enterprises in the country. There are 554,000 medical and medical equipment supply outlets in rural areas. The distribution is extremely scattered. Limited regulators must face ubiquitous regulatory targets. Can be imagined. It can be said that excessive competition and low industrial concentration have become the biggest constraints to the weak foundation of medical equipment safety in China.
From the perspective of consumption structure, China is a country with a large population and a large consumer of medical devices. The consumption structure is extremely complicated, and objectively provides a living space for low-quality medical devices. At present, China's medical device market has formed a "one China, three worlds" pattern: high-priced imports and new implantable, radioactive medical devices account for nearly 80% of the market share of big cities and top three hospitals; Domestic brand medical devices are the mainstay; some low-cost medical devices are squeezed into the countryside. Due to the low profit margin, large and medium-sized enterprises have gradually withdrawn from the rural market, and many rural areas have repeated use of disposable medical supplies, and the security situation is worrying.
Second: the regulatory agencies are not sound enough
Theoretical studies have shown that the goals, powers, and specialization of regulators are important variables in explaining regulatory performance. Relative to the rapid development of the industry, China's medical device regulatory agencies are relatively lagging behind, facing at least three challenges.
First, the target setting is blurred. At the beginning of its establishment, the State Food and Drug Administration has established a diversified work policy of “supervising as the center, supervising, helping, and promoting the combinationâ€. For example, Article 4 of the Regulations on the Supervision and Administration of Medical Devices stipulates that the drug regulatory department of the State Council shall cooperate with the State Council. The comprehensive economic management department implements the national medical device industry policy. It can be seen that it must not only ensure the safety and effectiveness of medical devices, but also pay attention to the benefits of the industry. In a sense, the drug regulatory department must also ensure that patients can use medical devices that are both high quality and inexpensive. Obviously, the diversification of objectives blurs the relationship between public interest and commercial interests. Individual drug regulatory officials even emphasize “helping enterprises to do things and promote economic developmentâ€, thus affecting the effectiveness of policy formulation and implementation.
Second, the allocation of authority is scattered. Although the SFDA is committed to becoming an integrated management department for pharmaceuticals and medical devices, the mandate to achieve multiple policy objectives is scattered across other sectors. Especially in the fields of medical device use, clinical trials and price management, the State Food and Drug Administration has to share powers with other departments or even no authority at all. In general, when the goals of different departments are inconsistent and the behavior is not coordinated, the regulators have to consider factors other than their own work when making decisions, which in turn restricts autonomy. For example, current regulations only impose restrictions on the production of medical devices that do not meet national and industry standards, but there are no restrictions or legal responsibilities for the use of non-compliant medical devices, which makes the drug regulatory department weak in the regulation of medical devices in use. In reality, the internal management of medical devices by grassroots medical institutions has problems such as chaotic procurement channels, unsatisfactory implementation of quality acceptance procedures, and lack of traceability of products. Medical device safety is difficult to guarantee.
Third, the professional level is weak. In order to cope with the high-tech risks brought about by large-scale industrial production, regulators are bound to emphasize professional supervision. For example, the US Food and Drug Administration employs thousands of doctors in medicine and chemistry as a regulatory technology support, and has tens of thousands of professional law enforcement officers patrolling the factory. In comparison, the professional level and law enforcement capacity of China's drug regulatory authorities are still insufficient. When many grassroots drug regulatory departments were established, most of the personnel came from non-medical systems. At present, most city and county drug regulatory departments do not have full-time medical device supervisors, and fewer supervisors with relevant professional knowledge. In the image, high-tech medical device products such as sound, light, electricity and new materials have entered the medical institutions for medical examinations, but our regulatory technology still stays in the syringes. The era of small cotton swabs. In addition, although the prefecture-level cities have basically set up drug testing institutions, the setting of medical device testing institutions still needs to be strengthened. These phenomena are particularly serious in the central and western regions.
Third: the supervision method is not effective enough
Public policy usually includes three types of means: coercion, guidance and education. Therefore, the ideal combination of medical device safety supervision policy tools should be a combination of direct intervention, economic incentives and self-regulation, so that it can play an active role in different policy areas. It must be acknowledged that China's current medical device safety regulatory policies have drawbacks in all three aspects.
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