Do enterprises need to apply for medical device registration
or filing when importing X-ray tube components from abroad? You should know that there is a big difference between importing "medical devices" and "medical device components
". Let me explain it in detail.
1、 Medical devices
（1） What is a medical device?
According to Article 103 of the Regulations on the Supervision and Administration of Medical Devices (State Council Order No. 739), medical devices refer to instruments, equipment, instruments, in vitro diagnostic reagents and calibrators, materials, and other similar or related items directly or indirectly used in the human body, including necessary computer software. Its effectiveness is mainly obtained through physical and other means, not through pharmacology, immunology, or metabolism, or although these methods are involved, they only play an auxiliary role. Its purpose is to:
1. Diagnosis, prevention, monitoring, treatment or relief of diseases;
2. Diagnosis, monitoring, treatment, relief or functional compensation of injuries;
3. Testing, substitution, regulation, or support of physiological structures or processes;
4. Support or maintenance of life;
5. Pregnancy control;
6. Provide information for medical or diagnostic purposes by examining samples from the human body.
（2） How does the country manage medical devices?
According to the Regulations on the Supervision and Administration of Medical Devices, the state implements classified management of medical devices based on their degree of risk.
The first type is medical devices with a low level of risk, and implementing routine management can ensure their safety and effectiveness. Implement product filing management for this type of medical device.
The second type is a medical device with moderate risk that requires strict control and management to ensure its safety and effectiveness.
The third category is medical devices that have high risks and require special measures to strictly control and manage them to ensure their safety and effectiveness.
The state implements product registration management for Class II and Class III medical devices.
（3） How does the customs supervise imported medical devices?
1. Imported medical devices must obtain the filing or registration certificate from the food and drug regulatory department of the State Council (except for special circumstances such as scientific research and application for registration). When applying for import, the filing or registration certificate number should be filled out proactively. The customs conducts online verification on the electronic data of the import medical device record/registration certificate (including the medical device registration certificate
, the first class medical device record certificate) and the electronic data of the import medical device Customs declaration.
2. Imported medical devices should have Chinese instructions and labels, and comply with relevant regulations and mandatory standards. The instructions should also specify the origin of the medical device and the name, address, and contact information of the domestic enterprise legal person designated by the overseas medical device registrant and registrant in China. If there are Chinese instructions or labels, or if the instructions or labels do not comply with the provisions of this article, they shall not be imported.
3. Customs shall conduct inspections on imported medical devices in accordance with the law. Those that fail the inspection shall not be imported. At the same time, it is prohibited to import medical devices that have expired, expired, or become obsolete.
2、 Medical device components
Medical device components
（1） What are medical device components?
Medical device components, as the name suggests, are components that act on medical devices. At present, China's imported medical device related products are mainly high value consumables and large medical equipment, while some high-end medical device products
, core components
, and key raw materials still have a high import dependence.
（2） How does the customs supervise the import of medical device components?
For the parts and components provided to medical device manufacturers
to produce medical devices as Means of production, according to the definition of medical devices in Article 103 of the Regulations on the Supervision and Administration of Medical Devices, the State Food and Drug Administration believes that because they do not have the purpose described in Article 103 of the Regulations, they do not need to separately handle the medical device filing or registration, and they are declared as non-medical devices.