——Thinking about the implementation of "Medical Device Manufacturing Quality Management Standards"
Food and Drug Administration of Xiamen City, Fujian Province He Qinghang Xu Huadong
　　 The "Medical Device Manufacturing Quality Management Code" (hereinafter referred to as the "Code") was released on December 16, 2009, and will be formally implemented on January 1, 2011. The promulgation and implementation of the "Specifications" laid a legal foundation for the transition from "managing the source and final products" to "overseeing the whole process". However, looking at the history and current situation of my country’s medical device supervision, the author believes that the implementation of the "Specifications" only guarantees that enterprises continue to produce medical devices under a production quality management system that complies with China’s current medical device management regulations. For the purpose of safety and effectiveness, effective measures must be taken to solve this problem so that the "Code" can truly play its due role.
　　 Problems in the implementation of the "Code"
　　 my country introduced the concept of quality management system from the "Measures for Quality System Assessment of Medical Device Manufacturers" formulated in 2000, and the "Specifications" were only promulgated on December 16, 2009, which can be described as "a sword of ten years." However, the implementation of the "Regulations" still faces some problems. Here, the author will discuss my own views based on the current situation of medical device supervision in my country.
　　 One is that the regulatory loopholes in the development process are difficult to ensure the effect of the implementation of the "Specification".
　　 At present, the registration test samples of medical devices are sent to the testing organization by the enterprises themselves. This brings regulatory loopholes to medical device management. Especially for products registered for the first time, since the testing is done on samples that are not randomly sampled, the resulting testing data can hardly represent the technical performance of the company’s normal continuous mass production of products, nor can it represent the uniform level of product quality, especially if The enterprise fraudulently purchases the same products produced by other manufacturers that have been approved for listing on the market and puts their own labels on them for inspection, and the authenticity of product development and production cannot be inspected. Under this circumstance, the implementation of the "Specification" inspection on the production enterprise will not achieve the desired effect and cannot guarantee the product quality. In addition, in the newly revised "Administrative Measures for the Registration of Medical Devices" issued in 2004, the pre-recheck procedure for registered product standards was cancelled. Each testing agency only evaluates whether the samples submitted by the company meet their product standards, losing the original It is the best opportunity to review the scientificity, rationality, applicability, feasibility of registration standards and the implementation of mandatory national standards and industry standards. Therefore, when the regulatory authority conducts the "Code" inspection on the company, since the time of the "Code" inspection is after the product registration and inspection, it is uncertain whether the products submitted for inspection by the company are produced under the requirements of the quality management system specified in the "Code" At the same time, there is no sampling after the inspection, and there is no guarantee that the performance of the product that has passed the "Code" inspection is consistent with the performance of the registered product.
　　 The second is that the preparations for the implementation of the "Code" need to be further strengthened.
The National Bureau has issued the "Standard" inspection management measures and the implementation rules for sterile and implantable medical devices and other supporting documents. The Medical Device Supervision Department has conducted a large number of inspectors training for the national medical device supervision system. The National Bureau Training Center Special training courses have been held for enterprises, and various provincial bureaus have also invited experts to publicize and implement the "Code" within their jurisdiction. However, from the current point of view, there are still insufficient preparations for the implementation of the Code, which will affect the effectiveness of the implementation of the Code. For example, the relevant systems stipulated in the "Specifications" are not sound enough. Chapter 2 of the "Measures for the Inspection and Management of Medical Device Production Quality Management Standards" stipulates the application materials and review procedures of enterprises. The application materials only stipulate the basic conditions of the enterprise and involve production There are very few technical data on quality management standards; the inspection tasks and the arrangement of manpower and material resources determined by the "standards" are unscientific. The National Bureau is responsible for pacemakers, artificial heart valves, endovascular stents and catheters, disposable plastic blood bags, A small number of inspection tasks for the six medical devices of animal-derived medical devices and allogeneic medical devices. Other tasks are undertaken by the provincial bureaus. As a result, most of the inspection tasks fall to the provincial bureaus. Some major medical device production provinces will soon Facing a huge workload. In the current situation where there are few medical device supervisors and heavy supervisory tasks, the contradiction is very prominent (the ratio of the total number of supervisors and manufacturers in the country is 1:70), especially the proportion of supervisors with medical equipment and related majors in the total number of supervisors In very small cases (according to statistics, only 7.2%), coupled with the inconsistency of the work level and grasping standards of the supervisory personnel in various provinces, it is indeed difficult to ensure the quality of the inspection work of the "Code".
　　 Suggestions on the implementation of the "Code"
　　To ensure the effectiveness of the implementation of the "Specifications", it is necessary to fully understand and effectively solve the problems facing the implementation of the "Specifications" in order to achieve the goal of ensuring the safety and effectiveness of marketed medical device products. In response to the above problems, the author makes the following suggestions:
　　 First, strengthen the supervision of medical device development. It is recommended to amend the "Medical Device Registration Management Measures" to stipulate the procedures for the drug regulatory department to randomly sample and seal samples for registration inspection and product standards review.
　　Second, fully prepare for the implementation of the "Code". The implementation of the "Regulations" is a systematic work. It is necessary to make careful preparations for all links from enterprise declaration, document review to on-site inspections to ensure the smooth implementation of the "Regulations". The implementation of the "Regulations" review and inspection is a highly professional work. Under the current circumstances, it is necessary to recruit medical device-related professionals, especially biomedical engineering talents, into the medical device supervision team, and gradually establish a team of full-time inspectors .
　　Good methods should have good results. Therefore, we need to do a good job in the implementation of the "Code", establish and improve the relevant systems of the "Code" and the implementation details of various medical devices, so that the "Code" has stronger operability.
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　——China Medical News