On March 17, the State Food and Drug Administration announced in a press conference that in order to solve the hotspots and difficult issues of medical devices that are highly socially concerned and the people have expressed strong feedback, further regulate the market order, and severely crack down on violations of laws and regulations. Beginning in the middle of the month, a five-month medical device "five rectification" special action was launched nationwide, focusing on rectifying five behaviors including false registration and declaration of medical devices, illegal production, illegal operation, exaggerated publicity, and use of unlicensed products.

In recent years, my country's medical device industry has developed rapidly. In general, the safety situation of medical devices has been steadily improving. However, due to the late development of the medical device industry in my country, the overall scale of the industry is relatively small, and the industrial foundation is relatively weak. Some companies violate laws and regulations from time to time, and some product quality and safety have hidden dangers, which bring the safety and effectiveness of the public’s use of medical devices. Hidden dangers and hazards.

In response to the prominent problems in the medical device industry, the main contents of this special action are: first, to rectify false registration declarations, focusing on rectifying the untrue behaviors of the second and third categories of medical devices in the first registration application, and to carry out submissions to manufacturers in accordance with regulations The second and third categories of medical device registration application materials (the focus is on clinical trial reports) and the authenticity of the sample production process are organized to verify the authenticity of the registration process. The second is to rectify illegal production behaviors, focusing on the rectification of disposable infusion devices, disposable urinary catheters (bags) that use non-compliant raw materials and are not sterilized as required, condoms are commissioned to be produced without filing, hemodialysis Concentrates do not comply with the standard factory inspection and other acts. The third is to rectify illegal business activities, focusing on rectifying the sales of second and third categories of medical devices without permission in an experiential manner, operating decorative color flat contact lenses and hearing aids without a license, and failing to store and transport in vitro diagnostic reagents as required. The fourth is to rectify exaggerated propaganda behaviors, focusing on the treatment of low back pain, myopia, diabetes and high blood pressure and other medical devices such as patch and physical therapy for illegal propaganda; unauthorized publication of illegal advertisements without approval or tampering with the approval content, exaggerating product efficacy and Scope of application; use of medical research institutes or use the names and images of experts and patients to prove efficacy, etc. for illegal advertising. The fifth is to rectify the use of unlicensed products, focusing on the use of unlicensed in vitro diagnostic reagents in medical institutions.

The special action will take the key products, key enterprises, and key case clues as breakthrough points. According to the work mode that combines investigation, rectification and standardization, the inspection method of unannounced investigation, centralized investigation and surprise inspection will be adopted, highlighting the point-by-point, full-process supervision and implementation. Equal emphasis on construction, rectification and standardization while restructuring, and focusing on the "four combinations": combining special actions with daily supervision, combining special actions with medical device quality travel activities, and combining special actions with medical device safety publicity month activities , Combine special actions with the creation of an atmosphere of social co-governance, and strive to form a new regulatory pattern in which all parties participate, the public benefits, and industry development. During the medical device quality journey, large-scale surveys, interviews and reporting activities were carried out to publicize typical enterprises, expose violations of laws and regulations, suppress evil and promote good, and popularize the knowledge of safe use of equipment.

The General Administration requires that in special actions, all localities must strictly implement the "Regulations on the Supervision and Administration of Medical Devices" and the "Special Provisions of the State Council on Strengthening the Supervision and Administration of Food and Other Products". Any violations of laws and regulations shall be dealt with promptly, strictly, and seriously. Penalties are imposed in accordance with the upper limit prescribed by laws and regulations; if the circumstances are serious, the licenses of the producers and operators and products shall be revoked; if a crime is suspected, all shall be transferred to the public security organs for criminal responsibility; all products with potential safety hazards shall be stopped from selling and using , Order the company to recall and supervise the destruction.

In special actions, the General Administration will supervise the implementation of the "five rectifications" of medical devices in various regions, supervise key cases, and actively strengthen communication and cooperation with public security, health and family planning, industry and commerce and other departments. At the same time, local food and drug regulatory agencies at all levels are required to implement territorial management responsibilities.

Tips:

1. Consumers should pay attention to the "three essentials" when purchasing medical devices:

One must understand the scope of application of the product. Consumers should carefully read the instructions when purchasing medical devices to understand the product's mechanism of action, scope of application, usage, precautions and contraindications, etc. Some of them should be purchased and used under the guidance of a doctor, and should not be credulously promoted.

Second, check the product license. Medical devices must obtain legal qualifications before they can be marketed, such as product registration number and production license number. The packaging and instructions of the medical device should be printed with the legal certification number of the product and the manufacturer. If there is no corresponding legal certificate number on the product packaging and manual, it is not a legal medical device. Consumers can log on to the website of the State Food and Drug Administration for inquiries.

Three, I want to ask for a ticket to purchase the product. The bill is the consumer's proof of purchase and plays an important role in product warranty and quality complaints. Consumers should purchase medical equipment in formal business premises and obtain relevant bills. They must not save trouble or be greedy, otherwise they will not be able to protect their rights.

2. What is a medical device, and how does my country implement medical device registration management?

Answer: Medical devices are instruments, equipment, appliances, materials, etc. that have medical purposes. They mainly use physical methods to prevent, diagnose, treat, monitor, and alleviate diseases, or diagnose, treat, monitor, and alleviate injuries or disabilities. Compensation, research, substitution, adjustment of anatomical or physiological processes, pregnancy control, etc. Medical devices are managed in accordance with the degree of risk. The first category is medical devices that are sufficient to ensure their safety and effectiveness through routine management, such as surgical instruments, bandages, cotton swabs, etc.; the second category refers to their safety and effectiveness Medical devices that should be controlled, such as sphygmomanometers, electrocardiographs, condoms, etc.; the third category refers to implanted in the human body, used to support, maintain life, or have potential risks to the human body, and its safety and effectiveness must be strictly controlled Medical devices, such as pacemakers, implantable devices, vascular stents, etc. According to different classifications, medical device registration is reviewed and approved by the municipal, provincial, and national food and drug regulatory authorities.