On March 17, the State Food and Drug Administration announced at a press conference that in order to solve the hot and difficult problems of medical devices with high social concern and strong public reaction, further standardize the market order and severely crack down on violations of laws and regulations, the General Administration decided to carry out a five-month "five rectification" special action of medical devices nationwide from the middle of March, focus on the rectification of medical devices false registration declaration, illegal production, illegal operation, exaggerated publicity, the use of unlicensed products and other five acts.

In recent years, China's medical device industry has developed rapidly, and on the whole, the safety situation of medical devices is stable and good. However, due to the late development of my country's medical device industry, the overall scale of the industry is small, and the industrial foundation is relatively weak. Some companies' violations of laws and regulations occur from time to time, and some product quality and safety have hidden dangers, which brings safety and effectiveness to the public's use of medical devices. Hidden dangers and hazards.

In view of the outstanding problems existing in the medical device industry, the main contents of this special action are as follows: first, to rectify the false registration declaration behavior, focusing on the untrue behavior of the first registration application of the second and third types of medical devices, and to carry out the organizational verification of the authenticity of the first registration application materials (focusing on clinical trial reports) and sample production process of the second and third types of medical devices submitted by the manufacturing enterprises in accordance with the regulations, focus on the verification of the registration process due to reporting. The second is to rectify illegal production behaviors, focusing on the production of disposable infusion equipment, disposable catheters (bags) using raw materials that do not meet the standards, and failure to sterilize as required, condoms are commissioned for production without filing, and hemodialysis Concentrates are not subject to factory inspection according to standards. The third is to rectify illegal business activities, focusing on the unauthorized sale of second and third types of medical devices in an experiential manner, the unlicensed operation of decorative color flat contact lenses and hearing aids, and the failure to store and transport in vitro diagnostic reagents as required. The fourth is to rectify exaggerated publicity, focusing on illegal publicity of medical devices such as low back and leg pain, myopia, diabetes and hypertension, and physical therapy for illegal publicity; publishing illegal advertisements without approval or tampering with the approved content, exaggerating the efficacy and scope of application of products; Using medical research institutes or using experts, patients as proof of efficacy and image, etc. to carry out illegal advertising. The fifth is to rectify the use of unlicensed products, focusing on the use of unlicensed in vitro diagnostic reagents by medical institutions.

The special action will take the clues of key products, key enterprises and key cases as the breakthrough point. According to the working mode of combining investigation, rectification and standardization, the special action will adopt the inspection method of combining secret investigation, centralized investigation and surprise inspection, highlight the point to the surface and the whole process supervision, implement the side rectification construction, rectification and standardization, and pay attention to the "four combinations": that is, the combination of special action and daily supervision, the special action is combined with the medical device quality travel activities, the special action is combined with the medical device safety publicity month activities, and the special action is combined with the creation of a social co-governance atmosphere, and strive to form a new regulatory pattern of participation of all parties, public benefit, and industry development. During the activity of medical device quality travel, large-scale research, interview and report activities were carried out to publicize typical enterprises, expose illegal behaviors, suppress evil and promote good, and popularize the knowledge of safe use of equipment.

The General Administration requires that in special operations, 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 the Safety of Food and Other Products. If violations of laws and regulations are found, they will be dealt with promptly, strictly, and severely. And impose penalties in accordance with the upper limit prescribed by laws and regulations; if the circumstances are serious, the licenses of producers, operators and products shall be revoked; suspected of crimes, all products shall be transferred to the public security organs for criminal responsibility in accordance with the law; all products with potential safety hazards shall be stopped from sale and use, and enterprises shall be ordered to recall and supervise their destruction.

In the special action, the General Administration will supervise the "five rectification" of medical devices in various regions, supervise the handling of 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 supervision and administration departments at all levels are required to implement territorial management responsibilities.

Tips:

Consumers should pay attention to the "three important" when purchasing medical devices ":

To understand the scope of application of the product. Consumers should carefully read the instructions when purchasing medical devices, clarify the mechanism of action, scope of application, usage, precautions and contraindications of the product, and some should be purchased and used under the guidance of a doctor, and do not believe in sales.

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

Third, ask for a bill 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 buy medical devices in formal business places and ask for relevant bills. Don't try to save trouble and be greedy for cheap, otherwise they will not be able to protect their own rights and interests.

2. What is a medical device and how does China implement medical device registration management?

Answer: Medical devices are instruments, equipment, appliances, materials, etc. with medical purposes. They mainly use physical methods to prevent, diagnose, treat, monitor, and relieve diseases, or diagnose, treat, monitor, relieve, and compensate for injuries and disabilities., Research, replace, adjust, and control pregnancy in anatomical or physiological processes. Medical devices are managed according to the degree of risk. The first category refers to medical devices that can ensure their safety and effectiveness through regular management, such as surgical instruments, bandages, cotton swabs, etc.; the second category refers to medical devices that should be controlled for their safety and effectiveness, such as sphygmomanometers, ECG machines, condoms, etc.; the third category refers to implantation into the human body, used to support, maintain life or have potential danger to the human body, medical devices whose safety and effectiveness must be strictly controlled, such as cardiac pacemakers, implanted devices, vascular stents, etc. According to different classifications, medical device registration is reviewed and approved by the districted municipal, provincial and national food and drug regulatory authorities.