The new edition of Regulations on the Supervision and Administration of Medical Devices was promulgated by Decree No. 650 of the State Council of the People's Republic of China on March 7, 2014, and has been in effect since June 1, 2014. The new regulations aim to "establish the strictest regulatory system covering the whole process". The new Regulations specify the imported medical devices. If the inspection is not qualified and the import is not allowed, it puts forward higher requirements for the work of the inspection and quarantine department. It has been more than two years since the implementation of the New Regulations. However, the author found that many importing enterprises of medical devices still lack sufficient understanding of the Regulations. The requirements for instructions and labels are still on the basis of the original Decree No. 10, which directly leads to a large number of imports. Unqualified medical devices. In the first-line inspection work, the author summarizes the following problems in the current imported medical device instructions and labels.
There is no Chinese label on the outer packaging of medical devices.
Since most of the imported medical devices are produced abroad, they are often labeled only in English and not in Chinese.
According to Article 42 of the Regulations on the Supervision and Administration of Medical Devices, "Imported medical devices shall have Chinese instructions and labels. The instructions and labels shall meet the requirements of the Regulations and the relevant mandatory standards, and the instructions shall specify the origin of the medical devices and the names, addresses and contact methods of the agents. No import shall be allowed without Chinese instructions, Chinese labels or instructions or labels that do not conform to the provisions of this Article."
Therefore, medical devices without Chinese labels will be judged as substandard products when imported.
Therefore, it is suggested that importers strengthen communication with foreign production enterprises and attach Chinese labels to production links. In some special customs regulatory zones, importers can also make full use of the policy advantages of the regulatory zones to uniformly add Chinese labels before the products are reported for import.
The production date and service life are not marked in the Chinese label.
According to the provisions of Article 27 of the Regulations on the Supervision and Administration of Medical Devices, the instructions and labels of medical devices shall indicate the date of production and use, or the date of expiration. That is to say, in the Chinese label, not only the production date, but also the service life or expiration date need to be marked.
This is different from the requirement of the original Decree No. 10, which does not require the labeling of service life, which is also a major reason for the unqualified labeling of many imported medical devices.
For some kinds of medical devices, such as some equipment products, there is no expiration date or expiration date. If no expiration date or inapplicability is indicated in the registration test, it is not necessary to label them in the Chinese label.
The Circular of the General Administration of Food and Drug Administration on Implementing the Measures for the Registration of Medical Devices and the Measures for the Registration of Diagnostic Reagents in Vitro (Article 2 of the Food and Drug Administration  144) stipulates that the registration certificates of the second and third categories of medical devices which have been approved for registration before October 1, 2014 shall continue within the validity period. Effective. The instructions and original labels of the registered medical devices can continue to be used. This leads to the existence of new and old versions of label instructions in use, which is also an important reason for the unqualified label instructions of imported medical devices.
The name, domicile and production address of the production enterprise in the label do not conform to the information of filing or registration.
The residence of a medical device manufacturer generally refers to the registered address of the manufacturer, which is often different from the actual production address. When we judge the origin of the product, we mainly look at the actual production address of the product. Therefore, the production address in the Chinese label should be consistent with the actual production address, as well as with the record information or registration information.
Some medical device products have added new production address after obtaining the registration certificate, or the original production address has been changed but the original registration certificate production address has not been changed in time. This reflects that some medical device companies only pay attention to the acquisition of market access certificate (medical device registration certificate), and they do not understand the requirements of certificate change very well. As a result, the occurrence of the above-mentioned non-conformity, fundamentally speaking, is not enough attention to the strict management system of medical devices in our country.
In addition, some large medical device manufacturers may have multiple production addresses worldwide, all of which have been filed or registered. However, in the Chinese label of a single batch of products, the production address should only indicate the address of the actual production of the batch of products.
In order to make labels more convenient, some importers often print all the production addresses in the filing or registration information in the item of production address in the Chinese label, which is also unqualified.
For example, a medical device manufacturer produces puncture devices at many factories in the United States, Mexico and other countries. But it labels all the production addresses on the product, so it is impossible for consumers and regulators to tell which production address the batch of products originated from.
The product names of medical devices in Chinese instructions and labels are inconsistent with those in medical device registration certificate or record certificate.
According to Article 26 of the Regulations on the Supervision and Administration of Medical Devices, medical devices should use common names. The generic name shall conform to the naming rules for medical devices formulated by the food and drug supervision and Administration Department of the State Council.