Imported devices packaging marking problems and what are the solution to the proposal--Taiyuan medical equipment which is good

Introduction: Medical device instructions, labels and packaging identification is to identify product characteristics, covering product safety information of important technical documents, not only is the correct use of medical institutions and patients to ensure the safe and effective use of the device is an important basis, but also the primary drug supervision department to determine whether the product is legally qualified an important basis. However, I found in the medical device production, operation, use of units in the inspection, a considerable portion of imported medical devices in the labeling, instructions and packaging marking on the existence of many problems, such as product packaging and labeling without Chinese marking; no Chinese instruction manuals; no no certificate of conformity or factory inspection report; business units did not ask for imported commodity inspection certificates; the Chinese marking errors, and product registration certificate does not match, and so on. Serious violations of the "supervision and management of medical devices regulations", "medical device instructions, labels and packaging marking regulations" and other laws and regulations, disrupting the normal order of the medical device market in China, the harm is mainly manifested in the following aspects: (a) the safe use of medical devices can not be guaranteed. Medical device labels, instructions, etc. is the clinical medical personnel safe and correct use of medical devices based on text materials, no Chinese instructions, no Chinese labeling product scope of application, precautions and contraindications and other important content, depending on the clinical experience of medical personnel to use, it is difficult to guarantee the correct use of the product, and even the doctor and the patient to cause unnecessary physiological damage. In addition, with the improvement of people's living standards, many consumers to buy health care medical devices for use, such as the lack of complete and standardized Chinese instructions for use, it is also very difficult to protect the safety and effectiveness of consumer devices. (ii) for the grassroots regulatory work set up obstacles. Medical device manuals, labels and packaging markings is an important basis for grassroots regulators to determine whether the product is legal. At present, the grass-roots drug control personnel's English level is generally not high, it is difficult to read and understand the instructions, labels and packaging markings without Chinese, especially large-scale equipment and specialized products, it is difficult to find out whether the scope of application of the product label, specifications, models, etc. is the same as the registration certificate limited to the contents of the product is registered by the state. All these have brought great inconvenience to our daily law enforcement work. (iii) Providing convenience and means for illegal production and operation. A small number of medical device operators in order to cater to the domestic many users blindly superstitious foreign brands of psychology, to obtain greater economic benefits, some domestic low-end product repackaging, the use of some foreign language manuals, masquerading as imported high-tech products, fake, high-priced sales, and the consumer by the product's exquisite packaging and the so-called "foreign words Consumers are confused by the beautiful packaging and the so-called "foreign text", it is difficult to find the authenticity of the product and the advantages and disadvantages, resulting in deception, a painful lesson. Reason analysis: First, imported medical devices import channels are not standardized. At present, China has a lot of medical equipment, especially high-end medical equipment products and large-scale instrumentation, such as pacemakers, superconducting magnetic **** vibration, etc. rely on imports, but there is due to a considerable portion of the imported products are not specifically for our country's production, but rather will be exported to Europe and the United States countries and regions of the product through the smuggling channel directly into our country, these products have not been through the approval and registration of the drug regulatory authorities are some of the These products have not been approved and registered by the drug administration department, and they are all "original products" without any Chinese marking at all. Second, the illegal operation of imported medical equipment agencies and agents. Some agencies and agents, although in the product into the Chinese market, submitted with Chinese product instructions, labels and packaging identification of the registration data, but also after the approval of the National Bureau of registration, but after obtaining the certificate of registration, the agency or agent taking into account the need to save costs, and did not fulfill the obligations set out in the laws and regulations, but directly in the import of devices outside the original packaging and paste the homemade Chinese labels Instead, they directly paste homemade Chinese labels on the original packaging of the imported devices and sell them in the domestic market, resulting in the strange phenomenon of "legal approval, illegal sales". Third, the medical device laws and regulations are not perfect. The current "supervision and management of medical devices regulations" and other relevant regulations, although such illegal behavior to make prohibitive provisions, but in terms of legal liability but no corresponding provisions. In addition, the current legal system of the domestic medical device import registered agencies and agents of the lack of effective regulatory measures, is also one of the important reasons that lead to the import of equipment instructions, labels and packaging marking management is difficult. Fourth, medical institutions to purchase imported equipment management measures are not perfect. For a long time, the medical institutions focus on the ideological concept of medicine over equipment is y rooted, the management of China's imported medical devices, mandatory standards, safety requirements, etc. do not know enough, the lack of due protection awareness, failed to strictly implement the rules and regulations of the management of medical devices in the purchase of imported medical devices, the lack of its packaging, labeling and instructions and other elements of the audit of the awareness and skills. Suggestions and countermeasures: In addition to the customs in the import of medical devices at the source of strict control, drug supervision and management departments should also increase the following aspects of the initiative: 1. Supervisors must strengthen their own business learning and training. Medical device supervision has always been the weak link in the supervision of the drug supervision department, and the supervision of imported medical devices is one of the "soft underbelly", therefore, the medical device related laws and regulations and all kinds of medical devices to learn the basics of the moment can not be relaxed, only their own quality of business over the top, in order to practice in law enforcement practice to train a pair of "Golden eyes", so that all kinds of illegal behavior nowhere to hide, in order to effectively fulfill the duties of medical device supervision. 2. Should strengthen the supervision and management of medical devices laws and regulations of publicity and education. Only let the administrative relative know the law, understand the law, let the people know more about the basic knowledge of medical devices, in order to mobilize the whole society to participate in a wide range of *** with the creation of a good law enforcement environment. At the same time, the regulatory authorities should supervise the operation, the use of units as soon as possible to improve the management system of medical devices, and strictly enforced, in particular, to keep the purchase and acceptance. 3. Strict law enforcement and correct application of the law. Such as product instructions, labels and packaging without any Chinese marking, and no indication of the product registration certificate number, a clear violation of the "supervision and management of medical devices regulations," Article 16, 17 of the provisions. Should be in accordance with the provisions of Article 48 of the "Regulations for the Administration of Medical Device Registration", as "no certificate of registration of medical devices" for serious treatment. For the agent without authorization in the packaging on the qualification labeling behavior, in the strict sense, should be part of the production process, there should be strict procedures to control and labeling management, to prevent errors in the labeling behavior, and the agent obviously does not have the qualifications and capabilities, the drug administration department should be stopped and ordered to correct this behavior, the recall of the products have been listed, the seriousness of the case should bear the necessary legal responsibility. Serious cases should bear the necessary legal responsibility, and even cancel its agent qualification. 4. Further revise and improve the laws and regulations related to medical devices. The current "Medical Device Specifications, Labeling and Packaging Labeling Regulations" lacks strong penalties, and it is difficult to form an efficient law enforcement deterrent, such as Article 20, there are "unauthorized changes in the content of the registration review and filing of the instruction manual; the labeling of the listed products, packaging and labeling and the registered review and filing of the instruction manual contradicts the content, or violate the provisions of the other requirements; the product of medical devices, the content of the product is not in line with the registration review and filing of the instruction manual, or violation of this provision Other requirements; medical device product name or trade name in violation of these provisions; listed products are not in accordance with the provisions of the attached instructions, labels and packaging identification "and other violations only by the county level or above (food) drug supervision and management department to give a warning, ordered to make corrections within a certain period of time, and recorded in the regulatory file of the production enterprise, the cost of enterprises in violation of the law is low, and the profitability of space is large, which is likely to cause The cost of violating the law is low, while the profit margin is large, which can easily lead to the repeated violation of the law. At the same time, the medical device instructions, labels and packaging markings do not meet the requirements of the imported products, there should be clear and specific measures to deal with. In addition, it should also introduce as soon as possible the management of medical device import registered agents and agents to regulate their behavior. Shanxi Double Win Weiye Co., Ltd. exclusively for you, the health of the guarantee! Win-win Weiye science and trade.