Packaging marks of the most popular imported medic

  • Detail

Recently, during the inspection of the production, operation and use units of medical devices, the regulatory department of the author found that many foreign imported medical devices have many problems in labels. Some artists have long been tired of traditional means, instructions and packaging labels, which are mainly manifested in the following situations: first, there is no Chinese logo, such as some medical photosensitive materials There is no Chinese on the package of blood glucose meter and its reagent; Second, there is no Chinese instruction manual; Third, there is no certificate or the standard requirements of product inspection and testing machine are relatively strict; Fourth, the business unit cannot provide the import commodity inspection certificate; Fifthly, there are many errors in Chinese identification. Generally, the verification level of the laboratory machine manufacturer is excellent and in line with the national standard, which is inconsistent with the product registration certificate. For example, for a porcelain tooth casting alloy, the manufacturing country of the registration certificate is the United States, while the small label pasted on the package is Germany; One of the widely used testing machines for lower limb bone fixation is the well cover pressure testing machine fixed plate system, but the product label is pasted as an L-shaped support steel plate, which is actually a specification name in the lower limb bone fixation plate system, and the label does not have the generally required product registration number

the above problems obviously violate the regulations on the management of instructions, labels and packaging of medical devices, and also do not comply with the product quality law, which brings inconvenience and hidden dangers to manufacturers, medical institutions and consumers, difficulties to daily supervision, and convenience to illegal operators. Moreover, we also found in the inspection that the above problems are not just individual cases, but have reached the point of non governance, which must arouse our great attention

the author believes that in order to solve the problem of nonstandard packaging labels of imported medical devices, we must strengthen control and supervision from the following links:

first, we must solve the problem from the source. In the process of importing medical devices, the customs should not allow those without Chinese marks, instructions or unclear marks to pass the customs. Otherwise, once they enter the circulation process, it will be more difficult to recall them. Some products have no substitute products in the market for the time being. Even if they are found to be inconsistent with the regulations and consumers really need them, they may not be able to recall them

the second is to further standardize the laws and regulations in this regard. Article 6 of the current regulations on the administration of instructions, labels and packaging labels of medical devices stipulates that the text content of instructions, labels and packaging labels must be in Chinese. However, in terms of law, the requirements for manufacturers only stop at the county-level drug administration department where they are located giving a warning, ordering them to make corrections within a time limit, and recording them in the regulatory archives of the production enterprises. If the enterprise refuses to correct, there will be no further treatment according to the regulations. For sellers and users, if they find that they do not use Chinese signs and other non-standard medical devices, how to deal with them is completely blank, even there are no regulations ordering dealers to stop selling and users to stop using

medical device products are special commodities, which are easy to cause damage to the products themselves and may even endanger personal and property safety, which is related to the lives and health of the masses. While the non-standard instructions, labels and packaging of imported products have buried potential safety hazards for consumers. Therefore, it is necessary to strengthen the supervision of this kind of behavior by improving laws and regulations, strengthening management and other means to prevent the recurrence of similar phenomena

Copyright © 2011 JIN SHI