Medical Device Import and Export It is directly related to the lives and health of the people. Recently, customs across the country have investigated many cases of substandard imported medical devices, and have taken measures such as technical disposal, return, and destruction in accordance with the law, effectively safeguarding safety and protecting the legitimate rights and interests of domestic consumers. So, let's learn about the common problems in customs inspection of medical device import and export!

　　I. No Medical Device Import and Export Registration Certificate

　　Customs continuously discovered that imported dental scanners, X-ray tube components, lower limb rehabilitation machines, disposable sterile syringes, and root canal preparation machines did not have medical device registration certificates. The customs deemed the above goods unqualified and implemented return processing.

　　 Medical Device Import and Export It must be a medical device registered or filed in accordance with the "Regulations on the Supervision and Administration of Medical Devices". Customs shall conduct inspections of imported medical devices in accordance with the law; unqualified inspections shall not be imported.

　　II. Inconsistency between product model, place of origin, etc., and medical device registration/filing information

　　When inspecting imported dental comprehensive treatment machines, the customs 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 for the dental comprehensive treatment machine. When testing the imported titanium cage installation special accessories and intervertebral fusion system special package, it was found that the batch of goods did not have instructions and product labels, and it was impossible to confirm the place of origin and manufacturer information. Medical device import and export

　　The approved registered medical devices refer to medical devices that are consistent with the content specified in the medical device registration certificate and its attachments, and are produced within the validity period of the medical device registration certificate. In this case, the actual goods are inconsistent with the information on the medical device registration/filing certificate. "This" medical device is not "that" medical device, and it cannot escape the "sharp eyes" of customs officers.

　　III. Prohibition of importing "old-to-new" used medical devices

　　After inspecting the imported Eustachian tube pressure detector, the customs found that the Chinese label of the goods did not comply with the relevant provisions of the "Regulations on the Supervision and Administration of Medical Devices", the power plug was not in the Chinese style, the equipment was put into production in 2015, and the appearance had obvious scratches and wear marks, which is an old electrical appliance prohibited from import. Customs deemed the above goods unqualified and implemented return processing. Medical device import and export

　　IV. Goods with non-compliant Chinese labels and those that have not passed mandatory product certification

　　Customs inspection of imported oral X-ray digital tomography equipment found that the Chinese label elements were incomplete. The equipment includes computer host, keyboard, power cord, etc. (referred to as computer equipment). These computer equipment appeared in the medical equipment registration certificate. While the customs returned and disposed of the computer equipment in accordance with the law, the enterprise supervised the technical processing and qualification of the Chinese label of the medical device. Imported medical devices must have Chinese instructions and Chinese labels. The instructions and labels must comply with the relevant provisions of the "Regulations on the Supervision and Administration of Medical Devices". Non-medical device special equipment, i.e., general electrical equipment, shall meet the mandatory requirements of relevant national laws, regulations and technical specifications. Medical device import and export

　　V. Goods are damp, packaging is damaged under pressure, etc., affecting the use of the contents

　　When inspecting imported endotracheal tubes, separable coil systems and other medical devices, the customs found that some cartons were damp on the top and inside, and some packaging was damaged under pressure, affecting the use of the contents. The customs returned the goods according to law.

　　In this case, the internal goods were damaged due to dampness, packaging damage, etc., which does not comply with the relevant provisions of the "Commodity Inspection Law of the People's Republic of China" and its implementing rules. The customs will handle it in accordance with the law to effectively protect the life and health safety of Chinese consumers.

　　The above is an introduction to the common problems in customs inspection of medical device import and export. If you need to learn more, please feel free to contact us!