Medical Device "Five Rectification" Actions Launched

The State Food and Drug Administration issued a press briefing on March 17 to address the hot and difficult issues of medical devices with high social concerns and strong public opinions, further standardize the market order, and crack down on illegal and irregular activities. The General Administration of Administration decided to start mid-March. At the beginning, a five-month special campaign of "Five Remediation" for medical devices was launched throughout the country, focusing on five kinds of behaviors such as the false registration of medical devices, illegal production, illegal operations, exaggeration of publicity, and the use of unlicensed products.

In recent years, the rapid development of China's medical device industry, in general, the medical device security situation is stable and good. However, due to the late start of the development of China's medical device industry, the overall size of the industry is relatively small, the industrial foundation is relatively weak, some companies violate the law and conduct irregularities, and some product quality and safety have hidden dangers, which brings safety and effectiveness to the public use of medical devices. Hidden dangers and hazards.

In response to the outstanding problems in the medical device industry, the main contents of this special action are: First, rectify the false declaration of registration, focus on rectifying the untrue behavior of the second and third types of medical devices for the initial registration application, and carry out the submission of the production companies in accordance with the regulations. The first and third types of medical devices registered for the first time (focus on the clinical trial report) and the authenticity of the sample production process verification, the registration process has been due to report the key verification. The second is to rectify illegal production practices, focusing on remediation of one-time use of infusion devices, disposable use of catheters (bags) using raw materials that do not meet the standard production and not sterilized as required, condoms without authorization for unauthorized production, hemodialysis The use of concentrates does not follow the standard factory inspections. The third is to rectify illegal business practices, focus on remediation of the sale of second and third types of medical devices without authorization, experience of unlicensed operation of decorative colored plain contact lenses, hearing aids, and failure to store and transport in vitro diagnostic reagents as required. Fourth, rectify and exaggerate propaganda behavior, focus on remediation of low back pain, myopia, diabetes and high blood pressure and other types of medical equipment for physical therapy and other illegal propaganda; without approval or tamper with the contents of the unauthorized release of illegal advertising, exaggerating product efficacy and The scope of application; the use of medical research institutes or in the name of the experts, patients and images to prove the effectiveness of illegal advertising campaigns. The fifth is to rectify the use of unlicensed products, focusing on rectifying the behavior of medical institutions using undocumented in vitro diagnostic reagents.

The special operations will focus on key products, key enterprises, and key case clues. According to the work model of combining inspection, rectification, and standardization, the inspection methods combined with unannounced visits, centralized investigations, and surprise inspections will be adopted, and the supervision will be carried out with points, surfaces, and procedures. We must pay attention to the “four combinations”: the integration of special actions with daily supervision, the combination of special actions with the activities of medical device quality, and the combination of special actions with the promotion of medical device safety. The combination of special actions and the creation of an atmosphere of social co-governance has led to the formation of a new regulatory framework for participation by all parties, public benefit, and industry development. The quality of medical devices during the activities of thousands of miles, carry out large-scale investigation and reporting activities, publicity typical enterprises, expose violations of laws and regulations, suppress evils and promote good, universal knowledge of safe use of machinery.

The General Administration of State requires that, in special operations, all localities must strictly implement the “Regulations on the Supervision and Management of Medical Devices” and the “Special Provisions of the State Council on Strengthening the Supervision and Administration of the Safety of Food Products,” and all violations of laws and regulations shall be handled promptly, strictly, and severely. In addition, penalties shall be imposed according to the upper limits set by laws and regulations; if the circumstances are serious, licenses for production and business operators and products shall be revoked; all suspected of crimes shall be transferred to the public security organs for investigation of criminal responsibility according to law; sales and use of products with potential safety hazards shall cease. The company was ordered to recall and supervise the destruction.

The General Administration of China will supervise the "five rectifications" of medical devices in various localities during special operations, supervise and supervise key cases, and actively strengthen communication and cooperation with public security, family planning, and industry and commerce departments. At the same time, local food and drug supervision and administration departments at various levels are required to implement the responsibility for territorial management.

Tips:

1. Consumers must pay attention to "three things" when buying medical devices:

One must understand the scope of application of the product. When consumers purchase medical devices, they must carefully read the manuals to find out the mechanism of action, scope of application, usage, precautions, and contraindications of the products. Some of them must be purchased and used under the guidance of a doctor. Do not rely on promotion.

The second is to check the product license. Medical devices must be legally qualified before they can be listed and sold, such as product registration number and production license number. The legal certificates of products and production companies should be printed on the packaging and instructions of medical devices. If there is no corresponding legal identification number on the product packaging or the manual, it is not a legal medical device. Consumers can log on to the website of the State Food and Drug Administration to inquire.

Third, ask for a ticket to purchase the product. Bills are proof of purchase by consumers and play an important role in product warranty and quality complaints. Consumers should purchase medical equipment at their regular business premises and request relevant paperwork. Do not plan to save money or become obstinate. Otherwise, you cannot safeguard your rights and interests.

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

A: Medical devices are instruments, equipment, appliances, materials, etc. that are used for medical purposes. They mainly perform physical disease prevention, diagnosis, treatment, monitoring, remission, or diagnosis, treatment, monitoring, remission, and treatment of injuries and disability. Compensation, research, replacement, regulation of anatomical or physiological processes, pregnancy control, etc. Medical devices are managed in accordance with the degree of risk. The first type is medical equipment that can ensure the safety and effectiveness through routine management, such as surgical instruments, bandages, cotton swabs, etc.; the second type refers to its safety and effectiveness. Medical devices that should be controlled, such as sphygmomanometers, electrocardiographs, condoms, etc. The third category refers to the implantation of the human body, which is used to support, sustain life or pose a potential danger to the human body. Its safety and effectiveness must be strictly controlled. Medical devices such as pacemakers, implantable devices, and vascular stents. According to different categories, registration of medical devices shall be examined and approved by the municipal, provincial and national food and drug supervision and management departments of the district.