Q&A on Enforcement of Medical Device Production Address

Article 34 of the Measures for the Administration of Medical Device Registration stipulates: "If the following contents in the medical device registration certificate change, the production enterprise shall apply for a change and re registration within 30 days from the date of the change... (2) Production address
In practice, law enforcement personnel often encounter situations where the production address indicated on the medical device does not match the production address limited by the product registration certificate during inspections. Generally, medical devices without a product registration certificate are classified and punished, but there are some exceptions that require special attention.
What is the difference between the two addresses
Both the Medical Device Manufacturing Enterprise License and the Medical Device Product Registration Certificate have registered address and production address columns. What is the difference between two addresses?
Registered address refers to the registered office address that a medical device manufacturing enterprise intends to use during registration, which is reflected in its business license and is subject to the management of local drug regulatory, tax, industry and commerce management departments. There can only be one registered address.
The production address is the specific production address of the medical device. It can be multiple and should all be confirmed or certified by relevant management departments. In China, the production address and registration address of medical devices are often the same, but many imported medical devices have different registration addresses and production addresses, even distributed in two different countries.
In the registration management of medical devices, the production address is more important than the registered address. According to the relevant provisions of the Medical Device Registration Management Measures, even if there is a substantial change in the registered address, it only needs to be changed, but if there is a substantial change in the production address, it needs to be re registered. If the production address only changes verbally, it only needs to be changed.
[Case Review]
During an inspection by a local drug regulatory agency, it was found that the CT machine product registration certificate used by Hospital B in the jurisdiction was licensed to a company in the United States, but the production address indicated on the medical device label was in Israel. Is this behavior legal? Can it be classified as a medical device without a product registration certificate?
Since the product registration certificate is licensed to a company in the United States, the registered address should be in the United States, but the specific production address of medical devices depends on the limitations of the product registration certificate. If the production address specified in the product registration certificate is in Israel, such a device is clearly legal, but if the medical device is produced in the United States, it is not legal. If the limited production address is not in Israel, such products are unlicensed.
What are the restrictions on the production address
Medical device production should strictly follow the content specified in the product registration certificate. Similarly, medical device manufacturing enterprises that use components produced by themselves or other factories to assemble complete machines should conduct inspections according to the standards specified in the registration certificate. Only after passing the inspection can they be sold out of the factory. The registration certificate limits the production address to the entire machine, not to each component. That is, the production address column specifies the final assembly address of the entire machine.
[Case Review]
During an inspection by a local drug regulatory agency, it was found that the production address indicated on the label of a digital X-ray imaging system used by a hospital in its jurisdiction is consistent with the address specified in the product registration certificate. However, the label of the component wheeled mobile photography bed shows the production address in the United States, while the label of the detector shows the production address