Don't confuse the management ideas of gunpowder an

2022-07-30
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Don't confuse the idea of drug and equipment management follow the legal norms

there are a wide variety of medical devices, the legal norms are relatively lacking, and the ability requirements for supervisors are also high. However, in the grass-roots law enforcement team, the number of medical device supervisors is obviously insufficient, and the degree of specialization is not high. Sometimes they will use the idea of drug supervision to manage devices, resulting in wrong cases in law enforcement

who is the subject of obligation

h during the inspection, the law enforcement officers of the food and Drug Administration found that the scope of application of a medical device product produced by W enterprise in other provinces sold by X medical device operating enterprise, the performance structure and composition of B medical device product were inconsistent with the registration certificate. The law enforcement officers believed that the two products were in line with the provisions of Article 48 of the administrative measures for the registration of medical devices, and advocated that they should be recognized as having no registration certificate, The operating enterprise of X medical devices shall be punished in accordance with Article 39 of the regulations on the supervision and administration of medical devices. However, in the process of handling the case, X medical device operating enterprise raised doubts and believed that article 48 of the measures for the administration of medical device registration punished the obligatory subjects who violated Article 33, 34 or 35 of the measures, and the obligatory subjects of these three articles were all production enterprises. Moreover, the operating enterprise has verified the product qualification certificate when purchasing two kinds of medical devices and fulfilled the review obligation. Therefore, the enterprise has not violated relevant laws and regulations and should not be punished. In the case discussion stage, most law enforcement officers believed that for drugs, if the indicated indications or functional indications exceeded the specified range, they would be punished as fake drugs. Changes in the specifications and other contents of drugs need to be approved. Those that must be approved but have not been approved for production, such as 11V to 32V, shall be treated as counterfeit drugs. Article 48 of the drug administration law stipulates that the production (including preparation, the same below) and sale of counterfeit drugs are prohibited, and any act of selling counterfeit drugs shall be punished. These law enforcement officers believe that the sale of medical devices without registration certificates is similar to the sale of counterfeit drugs and should also be punished. Article 48 of the measures for the administration of registration of medical devices stipulates that the medical devices sold without re registration of medical devices according to law, or the medical devices sold are different from the contents specified in the registration certificate, or the contents of product specifications, labels, packaging marks and other contents are different from the contents specified in the registration certificate of medical devices are parallel, and the subject of obligations shall include not only the manufacturer, but also the seller. If the medical device business enterprise and user operate and use the medical devices with different product labels, packaging marks and the contents specified in the registration certificate, what should be done? The reply of the former State Food and Drug Administration on issues related to the instructions, labels and packaging marks of medical devices (gsyjsh [2006] No. 35) clearly stipulates that the contents of product instructions, labels and packaging marks are different from those specified in the medical device registration certificate, The manufacturer shall be treated in accordance with the relevant provisions of the regulations on the administration of instructions, labels and packaging marks of medical devices and the measures for the administration of medical device registration; The operating and using units shall be instructed to timely contact the manufacturer of the product, make corrections within a time limit, and notify the local drug regulatory department where the manufacturer is located if necessary. At the same time, the publicity and education on the regulations on the supervision and administration of medical devices shall be strengthened, and the operating and using units shall be urged to improve the system and control the purchase acceptance. It can be seen that the practice of directly punishing the operating and using units is incorrect. Article 16 of the regulations on the administration of instructions, labels and packaging labels of medical devices stipulates that the manufacturer shall be responsible for the authenticity and integrity of the instructions of medical devices. Article 18 stipulates that if the contents of the manual change involve the situation that the power battery enterprise must reduce the cost of the power battery and handle the re registration of the medical device as stipulated in the administrative measures for the registration of medical devices, it shall not be handled according to the manual change. Article 21 stipulates that if a medical device manufacturer increases the scope of application or indications of the product in the manual of the medical device without authorization, the (food) drug regulatory department at or above the county level shall punish it in accordance with Article 35 of the regulations on the supervision and administration of medical devices for failing to obtain the registration certificate of the medical device. It can be seen that in view of the situation that the manufacturer increases the scope of application or indications of the product in the manual of medical devices without authorization, it only stipulates that the manufacturer shall be punished according to the regulations, and it does not stipulate that the operating and using units shall be punished. Article 145 of the criminal law stipulates that: the production of medical devices and medical hygiene materials that do not meet the national and industrial standards to protect human health, or the sale of medical devices and medical hygiene materials that knowingly do not meet the national and industrial standards to protect human health, it can be seen that medical devices are different from drugs, and there is no distinction between fake and inferior medical devices. In the regulations on the supervision and administration of medical devices, only those without product registration certificate, expired As for the theory of invalid and obsolete medical devices, the criminal law uniformly identifies them as not meeting the national and industrial standards to protect human health. The production of medical devices that do not meet the national and industrial standards to protect human health does not emphasize subjective intent, but the sale of medical devices that do not meet the national and industrial standards to protect human health clearly constitutes a crime in the research report. It is required to have subjective intent. Following the legal norms, what legal obligations should medical device operating enterprises and users fulfill when purchasing medical devices? According to Article 26 of the regulations on the supervision and administration of medical devices, the verification obligations of medical device operating enterprises and medical institutions mainly have two points: first, whether the supplier is a manufacturing enterprise that has obtained the medical device manufacturing enterprise license or an operating enterprise that has obtained the medical device operating enterprise license; The second is to verify the conformity certificate of the product. In addition, there are many kinds of medical devices, which can be divided into class I, class II and class III in the regulatory category. The products are approved at the prefecture, provincial and national levels according to the classification. Due to the inconsistent standards of approval authorities at all levels and regions, the classification of product categories in the market is chaotic, and there are phenomena such as high classification and low classification and high classification. In addition, class I medical devices and some class II medical devices can be operated without a license. It is difficult for operating enterprises and users to distinguish the authenticity of products. It can be seen that the laws and regulations on the supervision of medical devices are not perfect at present, and there are few obligatory constraints on the operating and using units. The focus of the supervision of medical devices is still the medical device manufacturers. At present, there are still some cases of unauthorized processing of counterfeit medical products from regular manufacturers in the market. The drug regulatory department must strengthen the supervision of the operating and using units of medical devices. However, we should not use the idea of supervising drugs to manage the devices in the supervision. We should follow the laws and regulations, strengthen the understanding of laws and regulations, and avoid handling wrong cases in the actual law enforcement. There should be a law to follow for the punishment of medical device operators and users, and the punishment should be combined with education

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