The recall of unqualified medical equipment is unqualified

Business News Agency Aug. 17 News Recently, the head of a pharmaceutical company has posted on the Internet to inquire about penalties for operating unqualified medical devices. Originally, the local drug administration department sampled the sphygmomanometer operated by the company, and the inspection report issued by the inspection agency was unqualified for one of the indicators, thus the product was found to be unqualified. After receiving the non-conformity report, the pharmaceutical company recalled the 17 sphygmomanometers that had been sold. The person in charge of the company worried that it would be punished by the drug administration department. So, what should be done about this kind of operation of unqualified medical devices?

The so-called unqualified medical devices are medical device products that do not meet the standards of medical devices. There is a wide range of disputes in the administrative law enforcement circles of drug supervision and management as to how to deal with business links. The main reason is that there is no clear legal provision at present. The laws and regulations relating to medical devices include the Regulations on the Supervision and Administration of Medical Devices (the "Regulations") and the "Special Provisions of the State Council on Strengthening the Safety Supervision and Administration of Food Products" (the "Special Provisions") and the "Product Quality Law."

No relevant provisions of the Regulations

Some people think that Article 26 of the "Regulations on the Supervision and Administration of Medical Devices" should apply. "Medical device trading companies must not operate medical devices that have not been registered, have no certification, are expired, expired or have been phased out." Obviously, "no certification" and "nonconformity" are two different concepts, and "nonconformity" cannot be equated with "failure" or "disposal."

The "Regulations on the Supervision and Management of Medical Devices" does not mention how to deal with substandard products, so it cannot be dealt with in accordance with the Regulations.

Apply "special regulations"?

According to the relevant documents of the State Food and Drug Administration, medical devices are applicable to the "Special Provisions" and are better than the Regulations for the Supervision and Administration of Medical Devices. However, there are no provisions on how to deal with non-conforming products.

Similar to this is Article 3: "The production and business operators shall be responsible for the safety of the products they produce and sell. They may not produce or sell products that do not meet the statutory requirements." ... "If the value of goods is less than 5,000 yuan, it shall be subject to 5 A fine of 10,000 yuan; if the value of the goods is more than 5,000 yuan but less than 10,000 yuan, a fine of 100,000 yuan shall be imposed; if the value of the goods is more than 10,000 yuan, a fine of 10 to 20 times the value of the goods shall be imposed concurrently; causing serious consequences. If the original license issuing department revokes the license photo, the crime that constitutes the crime of illegal business or the crime of producing or selling shoddy goods, etc., the criminal responsibility shall be investigated according to law." The penalty measures are more severe.

Then, does the non-conforming product belong to a product that does not meet the statutory requirements? What are the statutory requirements? It is not clearly stated in the "special regulations." After the "Special Provisions" was promulgated, the state intensified the penalties and management of food safety in legislation in the food industry, and the "Food Safety Law" implemented afterwards is well reflected. According to Article 85, only 10 kinds of foods that seriously endanger food safety standards are “confiscated by illegal income, illegally produced foods, and tools, equipment, and raw materials used for illegal production and management; the value of food products for illegal production and management is insufficient. If the value of the goods is more than 10,000 yuan, a fine of five to ten times the value of the goods shall be imposed; if the circumstances are serious, the permit shall be revoked."

For unfair foods that generally violate the food safety standards, recall measures are taken. “Food production and marketing operators shall not be allowed to recall or stop operations after the relevant competent department has ordered them to recall or stop operating foods that do not meet food safety standards,” before giving the more stringent administrative penalties prescribed in Article 85.

According to the "Product Quality Law" sub-case processing

The drug regulatory department has the power to punish medical device illegal cases according to the "Product Quality Law." Article 70 of the "Product Quality Law" stipulates: "If the law or administrative regulations provide otherwise for the organs that exercise the power of administrative punishment, they shall be implemented in accordance with laws and administrative regulations." The State Council regulates the entire supervision of medical devices by the drug administration department. . At the same time, in accordance with the “Opinions on Several Issues Concerning the Implementation of the “Product Quality Law of the People's Republic of China” of the General Administration of Quality Supervision and Inspection, “the supervision and inspection of medical devices, feeds and feed additives, and other products, the State Council has formulated special administrative regulations for these products. Supervision and inspection shall apply the provisions of the administrative regulations; if there is no provision, the laws and regulations on quality and technology supervision shall apply. "There is no provision in the "Regulations on the Supervision and Administration of Medical Devices" for the treatment of unqualified medical devices, and there is no problem with the application of the "Product Quality Law." .

How to deal with unqualified medical devices according to the "Product Quality Law"? The second paragraph of Article 26 of the "Product Quality Law" stipulates: "The product quality shall meet the following requirements: (1) There are no unreasonable risks that endanger the safety of people and property, and there are national standards for the protection of human health and personal and property safety. Industry standards shall comply with this standard; (2) Have the use performance that the product should possess, except that the product has the performance of the product that is used to describe it; (3) It conforms to the product standard specified on the product or its packaging. , in line with the quality status indicated by product descriptions, physical samples, etc."

Unqualified medical devices must be in violation of one or more of the above provisions. The Product Quality Law stipulates different methods for handling products that violate the second paragraph of Article 26. In case of violation of the first item, the production and sales of products that do not meet the national standards and industry standards for the protection of human health and personal and property safety, as stipulated in Article 49, shall be ordered to stop production and sales, and to confiscate products that are illegally produced or sold. , Combine the illegal production and sale of goods with a value equal to or more than three times the value of the fine; if there is illegal income, the illegal income shall be confiscated; if the circumstances are serious, the business license shall be revoked; if the crime is constituted, criminal responsibility shall be investigated according to law.

For products that are generally unqualified, pursuant to Article 17 "If the quality of products subject to supervision and spot checks in accordance with the provisions of this Law is unqualified, the product quality supervision department that conducts supervision and spot checks shall order its producers and sellers to make corrections within a specified period of time. An announcement shall be made by the product quality supervision department of the people's government at or above the provincial level; after the announcement, if it fails to pass the review, it shall be ordered to suspend business and be ordered to rectify within a time limit; if the product quality is still unqualified after the rectification period expires, the business license shall be revoked. Where there is a serious quality problem, it shall be punished in accordance with the relevant provisions of Chapter 5 of this Law."

In summary, the treatment of unqualified medical devices should be specifically analyzed in accordance with the specific conditions of the Product Quality Law: there is a danger that endangers the safety of people and property, and does not meet the national standards and industry standards for the protection of human health and personal and property safety. If the infusion device's microbiological index exceeds the standard, it may endanger the health of the body and it will be treated according to Article 49. There are serious problems with the product's performance and labeling. If the product cannot be used normally, it shall be treated according to the relevant provisions of Chapter 5. For the general substandard products, such as medical rubber If the length of the paste does not match, the company will be ordered to make corrections, and unqualified medical devices will be recalled.