Source: China Journal of Food and Drug Administration.
1. No medical device registration certificate
The customs has continuously found that imported oral scanners, X-ray tube assemblies, lower limb rehabilitation training machines, disposable sterile syringes, root canal preparation machines and other medical devices have no medical device registration certificates. According to the law, the customs determines that the above-mentioned goods are unqualified and returns them.
Imported medical devices should be registered or filed in accordance with the regulations on the supervision and administration of medical devices. The customs shall inspect the imported medical devices according to law; Those that fail to pass the inspection shall not be imported.
Two, the goods model, origin and other medical device registration/filing information does not match.
When the customs inspected the imported dental comprehensive treatment machine, it was found that the actual model of the goods did not match the model of the medical device registration certificate provided by the enterprise, and the enterprise could not provide the medical device registration certificate of the arrived dental comprehensive treatment machine; During the inspection of the imported special tool kit for titanium cage installation and special package for interbody fusion cage system, it was found that this batch of goods had no instructions and product labels, so it was impossible to confirm the information such as the place of origin and manufacturer. After checking the filing number of imported medical devices declared by official website, National Medical Products Administration, it showed that the place of filing was Hungarian, while the importer declared the place of origin of the goods as China. According to the law, the customs determines that the above-mentioned goods are unqualified and returns them.
Medical devices approved for registration refer to medical devices that are consistent with the contents defined in the medical device registration certificate and accessories and are produced within the validity period of the medical device registration certificate. In this case, the actual goods are inconsistent with the information listed in the medical device registration/filing certificate, and the "this" medical device is not the "other" medical device, which cannot escape the "eye-catching" of customs officers.
Three, prohibit the import of old medical devices "with the old top new"
During the inspection of the imported eustachian tube pressure tester, the customs found that the Chinese label of the goods did not meet the relevant provisions of the Regulations on the Supervision and Administration of Medical Devices, the power plug was not in China standard, the equipment was produced in 2015, and there were obvious scratches and wear marks on the appearance, which belonged to the old electromechanical products that were prohibited from being imported. According to the law, the customs determines that the above-mentioned goods are unqualified and returns them.
According to the Announcement on Relevant Matters Concerning the Adjustment of the Catalogue of Used Mechanical and Electrical Products Prohibited from Import (Announcement No.106 of the General Administration of Customs of the Ministry of Commerce in 2018), the import of used medical devices listed in the announcement catalogue is prohibited.
Four, Chinese labels do not meet the requirements, carrying goods that have not been certified by compulsory products.
When the customs inspected the imported oral X-ray digital tomography equipment, it was found that the Chinese label elements of the equipment were incomplete, and the equipment also included computer mainframe, keyboard, power cord and other equipment (referred to as computer equipment). The above computer equipment was not reflected in the medical device registration certificate, was not special for the medical device, had not been certified by compulsory products and the power plug did not meet the national standards. The customs shall return the computer equipment according to law, and at the same time supervise the enterprise to carry out technical treatment on the Chinese label of the medical device until it is qualified.
Imported medical devices shall have Chinese instructions and Chinese labels. Instructions and labels shall comply with the relevant provisions of the Regulations on the Supervision and Administration of Medical Devices. Non-medical equipment, that is, general electrical equipment, should meet the mandatory requirements of relevant national laws, regulations and technical specifications.
Five, the goods are affected by moisture, packaging is damaged by extrusion, etc.
During the inspection of imported medical devices such as guide catheter and detachable spring coil system, the customs found that some goods on the top and inside of the carton box were wet, and some packages were squeezed and damaged, which affected the use of the contents. The customs returned the goods according to law.
In this case, the internal goods were damaged due to moisture, damaged packaging, etc., which did not meet the relevant provisions of the People's Republic of China (PRC) Commodity Inspection Law and the implementation regulations. The customs handled it according to law to effectively protect the life, health and safety of Chinese consumers.