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2023
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Enforcement Q&A on Medical Device Manufacturing Addresses
In the registration management of medical devices, the manufacturing address is more critical than the registration address. According to the relevant provisions of the "Measures for the Registration and Administration of Medical Devices"
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Article 34 of the "Administrative Measures for Medical Device Registration" stipulates: “If any of the following items in the medical device registration certificate undergoes a change, the manufacturer shall apply for an amendment and re-registration within 30 days from the date of the change... (2) Production address...”
In practice, law enforcement officers frequently encounter situations during inspections in which the stated manufacturing address on medical devices does not match the manufacturing address specified in the product registration certificate. Typically, such cases are classified and penalized as if the device lacked a valid product registration certificate. However, there are certain exceptional circumstances that require special attention.
What’s the difference between the two addresses?
Both the “Medical Device Manufacturing Enterprise License” and the “Medical Device Product Registration Certificate” have fields for both the registered address and the production 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. This address serves as the official point of reference for oversight and management by local drug regulatory, tax, and industrial and commercial authorities. Only one registered address is permitted.
The production address is the specific location where medical devices are manufactured. There may be multiple production addresses, all of which must be confirmed or certified by the relevant regulatory authorities. In China, the production address and the registration address for medical devices often coincide. However, for many imported medical devices, the registration address differs from the production address—and in some cases, the two addresses are located in entirely different countries.
In the registration management of medical devices, the manufacturing address is more critical than the registration address. According to the relevant provisions of the "Measures for the Registration and Administration of Medical Devices," if the registration address undergoes a substantial change, only a modification is required; however, if the manufacturing address undergoes a substantial change, re-registration is necessary. If the manufacturing address undergoes only a textual change, only a modification is sufficient.
[Case Commentary]
During an inspection, the local drug regulatory authority discovered that the CT scanner used by Hospital B in its jurisdiction had a product registration certificate licensed to a U.S. company; however, the manufacturing address indicated on the medical device label was located in Israel. Is this practice legal? Can it be classified as a medical device without a valid product registration certificate?
Since the product registration certificate authorizes a U.S. company, the registered address should be in the United States. However, the specific manufacturing address of the medical device depends on the limitations stated in the product registration certificate. If the manufacturing address specified in the product registration certificate is located in Israel, such a device is clearly legal; conversely, if the medical device is manufactured in the United States, it would be illegal. On the other hand, if the specified manufacturing address is not in Israel, then the product would be considered an unregistered product.
What content is restricted by the production address?
Medical device manufacturers shall strictly adhere to the specifications outlined in the product registration certificate during production. Similarly, whether medical device manufacturers use components they produce themselves or components sourced from other manufacturers for assembling complete devices, they must conduct inspections according to the standards specified in the registration certificate. Only after passing these inspections can the devices be released for sale. The address restriction specified in the registration certificate applies to the complete device as a whole, not to individual components. In other words, the address indicated in the production address field refers to the location where the final assembled complete device is completed.
[Case Commentary]
During an inspection, the drug regulatory authority in a certain area found that the digital X-ray imaging system used by a local hospital had product labels indicating a manufacturing address that matched the address specified on its product registration certificate. However, the labels on its component parts—specifically, the wheeled mobile radiography bed—showed a manufacturing address in the United States; the detector labels indicated a manufacturing address in Germany; and the high-frequency high-voltage generator labels showed a manufacturing address in China. Can such medical devices be classified as medical devices lacking a valid product registration certificate?
The product registration certificate’s limitation on the manufacturing address applies to the location where the final assembly of the complete device takes place, rather than to the manufacturing addresses of individual components. It is lawful to procure components from other factories or other countries for the production of medical devices; however, this does not apply to components that are regulated as medical devices themselves. Such components must obtain approval from the licensing authority at the time of registration or acquire a separate product registration certificate. Therefore, the medical device in the case 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 Instructions, Labels, and Packaging Markings for Medical Devices" stipulates that the text content of instructions, labels, and packaging markings for medical devices manufactured overseas must be in Chinese, with other languages permitted as supplementary. Articles 5 and 15 of the "Regulations on the Management of Instructions, Labels, and Packaging Markings for Medical Devices," as well as Article 48 of the "Administrative Measures for Medical Device Registration," specify that the content thereof must be consistent with the relevant information contained in the medical device registration certificate and instructions reviewed by the National Medical Products Administration. The production address is one of the items specified in the product registration certificate. If the production address indicated on the medical device label or instruction differs from the address stated in the product registration certificate, the device may be penalized as if it lacked a valid product registration certificate.
In November 2008, the State Food and Drug Administration issued the “Notice on Issues Relating to Labels and Packaging Markings of Medical Devices from Abroad,” which clarified: “According to international trade rules, overseas medical device manufacturers may indicate the country of origin—such as ‘Made in xx (country)’ or similar wording—on the labels and packaging markings of certain imported medical devices. This indication may differ from the country specified in the ‘Place of Manufacture/Production Address’ indicated on the Chinese labels and packaging markings. Such a situation does not violate the relevant provisions of the Administration’s No. 16 Order and No. 10 Order.”
It is evident that medical devices can be manufactured by procuring components from external suppliers, and the country of manufacture or manufacturing address indicated on these components may differ from the address specified in the product registration certificate. Only when the manufacturing address of the entire medical device itself changes can it be considered a violation of Article 48 of the “Measures for the Administration of Medical Device Registration.”
[Case Commentary]
The label of an imported medical device indicates “Made in Germany,” while the production address specified on its product registration certificate is located in the United States. The address indicated on the Chinese label is consistent with the production address specified on the product registration certificate. Is this device considered an unlicensed medical device?
As previously mentioned, according to the notice from the National Medical Products Administration, the designation “made in xx (country)” that is inconsistent with the product registration certificate is legally valid only when it refers to the country of component manufacture. If the finished device is indeed labeled “made in xx (country)” as indicated on the label, such medical device should be classified as a medical device lacking a valid product registration certificate. To further verify whether “made in xx (country)” refers to the place of final assembly or the country of component manufacture, inspection personnel may request and examine supporting documents such as the Certificate of Conformity for Imported Medical Devices, packing lists, shipping manifests, customs clearance documents, and commercial inspection reports for corroboration.
Designation of Contract Manufacturing Address
Article 34 of the "Administrative Measures for the Supervision and Management of Medical Device Production" stipulates: “For medical devices manufactured under contract, the instructions, labels, and packaging markings shall clearly indicate the name of the commissioning party, the name of the contract manufacturer, and the manufacturer’s address.” In this case, the medical device bears the production address of the contract manufacturer, which does not match the production address specified in the product registration certificate held by the commissioning party.
This behavior does not violate the provisions of Article 34 and Article 38 of the “Administrative Measures for Medical Device Registration.” In accordance with the principle that “special provisions take precedence over general ones,” commissioned manufacturing is governed by the “Administrative Measures for the Supervision and Administration of Medical Device Production” rather than the “Administrative Measures for Medical Device Registration.”
[Case Commentary]
During an inspection, the drug regulatory authority in a certain region discovered that the manufacturer of Device B had indicated the production address of Factory C in the “Production Address” field of the product registration certificate. Upon investigation, it was determined that the enterprise located at that address was a partner of the manufacturer of Device B. Factory C had been commissioned by Factory B to produce glucose meters. At the time of registration, the provincial drug regulatory authority where Factory B is located had included the address of the commissioned manufacturer in the product registration certificate as well. If Factory B were to commission another manufacturer to produce glucose meters, would such glucose meters be considered to have a changed production address, and could they be classified as medical devices lacking a valid product registration certificate?
Some products are prepared for registration even before they are officially registered, and in such cases, the product registration certificate cannot include the address of the contract manufacturer in the “production address” field. Contract manufacturing of medical devices does not fall under the circumstances specified in Article 12 of the Administrative Licensing Law; however, it does meet the conditions set forth in Article 13 of the same law, which states: “For matters listed in Article 12 of this Law that can be regulated through the following means, administrative licensing may not be required: (1) where citizens, legal persons, or other organizations can make autonomous decisions...; (4) where administrative agencies can address the issue through post-event supervision and other administrative management methods.”
Contract manufacturing is a matter for enterprises to decide autonomously. Administrative authorities may adopt post-event supervision measures to ensure the safety and effectiveness of medical devices. Contract manufacturing of medical devices does not require administrative approval; all that is needed is registration and filing. Any changes to the contract manufacturing arrangement only need to be reported, without requiring additional administrative approval. Since no administrative approval is required, the address of the contractor should not be included in the "production site address" field of the product registration certificate.
In the above case, which company B Factory commissions to manufacture blood glucose meters is at the enterprise’s own discretion and does not require approval from regulatory authorities. If Company B commissions a manufacturer other than Factory C—provided that the manufacturer complies with relevant laws and regulations governing contract manufacturing—then all that is required is to file the necessary (record-filing) procedures, and such activity would be entirely lawful.
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