There are about 16,000 medical device manufacturers in China. In 2013, the statistical output value exceeded RMB 200 billion. The system of laws and regulations implemented was the Regulations for the Supervision and Management of Medical Devices implemented on April 1, 2000. The establishment of this system has indeed played an active role in improving the legalization of medical device supervision in China and regulating the medical device market. However, the current regulatory system is based on the blankness of medical device regulations and the market economy has just started. Due to the limitations of historical conditions and the urgency of the time of introduction, there are many flaws in this kind of administrative supervision mentality of pre-certification interim intervention with the core of administrative license examination and approval. The design of this regulatory system is also not very good from the macro, long-term, strategic thinking to think about the issue. What is the focus of the contradiction in the medical device market? What should be managed in accordance with the law? What are the specific issues to be solved? What kind of system is designed? What is the purpose? What is the goal of China's medical device industry? This series of problems has not been well designed for the system and has not been effectively solved. Let us talk about some of our opinions on these issues:

I. The main contradictions of the medical device industry With the continuous improvement of the market economy, the increase in consumer demand for medical and health products, the emergence of new medical device business models, and the diversity of enterprise composition structures and the development and expansion of industry scale, the core issue is: : The contradiction between specification and development. Markets and enterprises have to break through the original institutional framework and regulatory system, and our regulatory measures have not improved with development. Under such circumstances, the current regulatory system has sometimes become an obstacle to the market economy process. This kind of supervision under the guidance of power will inevitably lead to the accumulation of contradictions. In the past, supervision mainly focused on supervision, banking, and promotion, and the promotion of investment promotion for local economic development became the main responsibility of the regulatory authorities, inadvertently diluting the main functions of supervision to protect public health and safety.

2. The deficiencies of the regulatory system for medical devices The current "Regulations on the Supervision and Management of Medical Devices" governing medical devices are mainly a system for the purpose of pre-transition intervention, specifically for the production of medical device companies, production licenses, product registration certificates and operations. A system design for three licenses. With such an institutional arrangement, companies will mistakenly believe that it is a one-time consumer behavior of the government and the market. Legal liability after the listing of an enterprise's products The government can pay for it, and the government has become the main body of regulations for the product market.

Take product registration approval as an example: If an enterprise wants to qualify for a certificate of market access product registration, it must: (1) be tested by a testing agency under the government; (2) a quality system assessment report by government personnel; (3) ) The government-recognized clinical trial report; of course, there are other supporting materials, the above information can be registered for four years. In order to report on these three one-time approvals, the enterprise is falsified with false information, the standard avoidance is light, the writing can't be done, the information cannot be written, the product standard is not set by the product's safety and effectiveness, and the prototype inspection and actual The inconsistency in the production of products, the delivery of samples is good, and careful processing, or even the purchase of other products for inspection, approval of the mass production is another matter; clinical data exaggerated validity, and some even falsified, at all costs Make a big fuss about the data. Such a system design allows the form of approval to be greater than the substance, and the validity of the registration certificate that is granted for listing is four years. However, our regulatory-level operationality and poor public transparency have left too many discretionary powers and freedom of interpretation for the administrative approval department, giving people a feeling of concealment and causing companies to hide behind. It is not open to the truth; there are few guiding principles and guidelines at the implementation level, and some systems cannot be practically operated. They only rely on subjective will and some imaginary actions. This is also one of the root causes of market chaos. On the other hand, we are now implementing a three-level examination and approval system at the national, provincial, and prefectural (city) levels. This kind of decentralized examination and approval system should be a good one. Unfortunately, the definition of "medical device" is too principled; the naming rules are ambiguous; the catalogue is not refined and standardized; the operating procedures are not uniform. All levels in the examination and approval process are free to interpret according to their own understanding and needs; a product at each level of approval, you can grant I, II, III categories of three categories, can be called on a variety of even a dozen or even a dozen names. The local bureaus approved by the State Bureau do not know that the national bureau approved by the local bureau is even more unclear. Besides, the country has not yet had a complete basic database. No one can tell how many medical device manufacturers in the country and how many registered products there are. Not to mention effective supervision. In terms of system design, the government itself has become the main body of the market, and the responsible person of the product? Because they are all approved and approved by the government and are valid for four or five years.

Third, the monotony of regulatory measures We talk about supervision, and always think of the three steps of issuing certificates, setting up people, and adding more. The most effective and minimal administrative cost for improving administrative effectiveness is to change ideas, change ideas, and innovate regulatory ideas; second is to change people or increase posts. As a paper document, the license and registration certificate have no practical significance. The substantive content under the certificate is objective and real. In the past few years, the examination and approval department has focused on issuing licenses as the main work, and the market inspection department has mainly investigated the existence of evidence, evidence, and fines. The problem of "Qi two drugs" is because the requirements of the system and GMP are not implemented and cannot be effectively implemented. The system is in name only. Medical equipment also has these problems. The quality management system cannot be established according to the actual situation of the company. The documents are copied and copied. Some quality system documents established by the company are used to install the facades. When the equipment is installed and checked, it cannot be effectively implemented, including certifications. Many of the institutions that demonstrate organizations have also received certification for their money. Effective supervision is not just a matter of certification. It has never considered the efficiency of supervision, the cost of administration and the long-term mechanism of dynamic supervision after evidence, as well as the exploration of market competition mechanisms, corporate credibility mechanisms, or the promotion of corporate self-discipline, and strengthening the Self-regulating self-regulation and other mechanisms, as well as rich social resources and strengths worthy of support - the establishment of an effective social supervision mechanism for third-party participation and so on.

Fourth, lack of market integrity.

Since the market players are not clear, many companies will not be concerned about the clinical problems after the products have been approved for listing or market transactions. They are not concerned with their own affairs, any adverse events, and the recall system. Some products have serious hidden dangers in safety and quality, and serious accidents have occurred in clinical practice. The first reaction of companies is not to effectively control the market risk of products, analyze product safety risks, but to how to balance them, and serious lack of integrity. However, we have not established that the company is the main responsibility of the market in the design of the system. Instead, government regulators are busy in the market to save fire.

V. Inadequate capacity of the supervisory team When a policy or system is established, whether or not the essence of the policy and the correct thinking of the leader can be truly implemented, the key is whether the specific implementer can be reflected in practical work. This is the ruling. ability. Regulatory medical device supervision also requires a high-quality supervision team. The medical device set up in the discipline is an interdisciplinary subject. It covers a wide range of subject areas and uses a large number of new technologies and materials. It involves cross-convergence of optics, electronics, ultrasound, magnetism, isotopes, and computers, including artificial materials and artificial organs. , biomechanics, monitoring instruments, diagnostic equipment, imaging technology, information processing, image reconstruction and other technologies are applied in medical device products; it is one of the symbols of a country's manufacturing and high-tech level. There are many types of medical device products and they are more complicated than drug technologies. In fact, companies are experts. To develop, design, and produce products, companies have the most say in product technology and quality. And our examination and approval examiner always asks the enterprise how to do what the manager poses when the business is not perfect and the professional level is not high, often making the enterprise at a loss. Because of the defects of the system, the position is not clear, the thinking is not clear, what is the key, what the core supervision should manage, and what kind of person to manage. In this way, the urgency, importance, and long-term effectiveness of supervision are neglected for a long time.