Article 34 of the Measures for the Administration of Medical Device Registration stipulates: “If any of the following items specified in the medical device registration certificate undergoes a change, the manufacturing enterprise shall, within 30 days from the date of such change, apply for an amendment and re‑registration… (2) The production address…”

　　In practice, during inspections, law enforcement officers frequently encounter situations where the manufacturing address indicated on a medical device does not match the manufacturing address specified in its product registration certificate. Such cases are typically classified and penalized as violations involving medical devices lacking a valid product registration certificate; however, certain exceptions warrant particular attention.

　　What is the difference between the two addresses?

　　Both the “Medical Device Manufacturing Enterprise License” and the “Medical Device Product Registration Certificate” include fields for the registered address and the manufacturing address. What is the difference between these two addresses?

　　The registered address refers to the office address that a medical device manufacturer intends to use when registering, as indicated on its business license, and serves as the official address for oversight by local drug regulatory, tax, and industrial and commercial authorities. Only one registered address is permitted.

　　The manufacturing address is the specific location where medical devices are produced. It may consist of multiple sites, all of which must be approved or certified by the relevant regulatory authorities. In China, the manufacturing and registration addresses for medical devices are often the same; however, for many imported medical devices, the registration address differs from the manufacturing address, and in some cases, the two are located in different countries.

　　In medical device registration management, the manufacturing address is more critical than the registered address. According to the relevant provisions of the Measures for the Administration of Medical Device Registration, if the registered address undergoes a substantive change, only an amendment is required; however, a substantive change to the manufacturing address necessitates re‑registration. If the manufacturing address changes only in terms of wording, no further action is required—only an amendment is needed.

　　[Case Commentary]

　　During an inspection, the local drug administration found that the CT scanner used by Hospital B in its jurisdiction had a product registration certificate issued to a U.S. company; however, the manufacturing address indicated on the medical device’s label was located in Israel. Is such conduct lawful? Can it be classified as a medical device lacking a valid product registration certificate?

　　Since the product registration certificate is licensed to a U.S. company, the registered address must be in the United States; however, the specific manufacturing location of the medical device depends on the limitations stated in the product registration certificate. If the certificate specifies a manufacturing site in Israel, such a device is clearly lawful; by contrast, if the medical device is manufactured in the United States, it would be unlawful. Moreover, if the designated manufacturing location is not in Israel, the product would be considered unlicensed.

　　What are the restrictions on production addresses?

　　Medical device manufacturing shall be conducted strictly in accordance with the scope specified in the product registration certificate. Similarly, when a medical device manufacturer assembles complete devices using either its own components or components produced by other manufacturers, it must perform inspections in compliance with the standards set forth in the registration certificate; only products that pass such inspections may be released for sale. The registration certificate’s restriction on the manufacturing address applies to the finished device as a whole, not to individual components. In other words, the manufacturing address field specifies the location where the final assembly of the complete device is carried out.

　　[Case Commentary]

　　During an inspection, the local drug administration found that, for a hospital within its jurisdiction, the production address indicated on the label of the digital X-ray imaging system matched the address specified in the product registration certificate. However, the labels on its component parts—namely, the wheeled mobile radiography table, the detector, and the high-frequency X-ray generator—indicated different production addresses: the table’s label listed the U.S., the detector’s label listed Germany, and the generator’s label listed China. Can such a medical device be classified as a medical device without a valid product registration certificate?

　　The product registration certificate imposes restrictions on the manufacturing address only with respect to the final assembly of the complete device, and does not extend to the manufacturing locations of individual components. Procuring components from other manufacturers or countries for the production of medical devices is lawful; however, this excludes components that are subject to medical device regulation. Such components must obtain approval from the competent regulatory authority at the time of registration or secure a separate product registration certificate. Accordingly, the medical device in question cannot be classified as a medical device lacking a product registration certificate.

　　Designation of the Manufacturing Address for Imported Medical Devices

　　Article 6 of the Regulations on the Management of Medical Device Instructions, Labels, and Packaging Markings stipulates that the text on instructions, labels, and packaging markings for medical devices manufactured outside China must be in Chinese, with the option to include additional languages. Articles 5 and 15 of the same Regulations, together with Article 48 of the Measures for the Administration of Medical Device Registration, provide that such content shall be consistent with the relevant information set forth in the medical device registration certificate and the approved instructions as reviewed by the National Medical Products Administration. The manufacturing address is one of the mandatory items specified in the product registration certificate; if the manufacturing address indicated on the medical device label or in the instructions differs from that stated in the registration certificate, the device may be subject to penalties as though it lacked a valid registration certificate.

　　In November 2008, the State Food and Drug Administration issued the “Notice on Relevant Issues Concerning Labels and Packaging Markings of Medical Devices Imported from Abroad,” which clarified: “Under international trade practices, overseas medical device manufacturers may indicate the country of origin on certain imported medical device labels and packaging—such as ‘Made in XX (Country)’ or similar expressions—which may differ from the country specified in the ‘Place of Manufacture/Manufacturing Address’ listed on the Chinese-language label and packaging. Such circumstances do not constitute a violation of the relevant provisions set forth in the Administration’s Order No. 16 and Order No. 10.”

　　It is evident that medical devices may be manufactured using externally sourced components, and the country of manufacture or manufacturing address indicated on those components need not correspond to the address specified in the product registration certificate. Only when the manufacturing address of the complete medical device changes would such a situation constitute a violation of Article 48 of the Measures for the Administration of Medical Device Registration.