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[Summary Description] In medical device registration management, the production address is more important than the registration address. According to the relevant provisions of the Medical Device Registration Management Measures, the registered address only needs to be changed even if there is a substantial change, but the production address needs to be re-registered if there is a substantial change. If the production address is only changed in a literal way, you only need to change it.

Article 34 of the Measures for the Administration of Medical Device Registration stipulates: "If the following contents of the medical device registration certificate change, the manufacturer shall apply for re-registration of the change within 30 days from the date of the change... (2) The address of production..."

In practice, law enforcement officers often encounter in the inspection of medical devices marked production address and product registration certificate limited production address does not match the situation, generally in accordance with the product registration certificate of medical devices for qualitative and punishment, but there are some exceptions need special attention.

What's the difference between the two addresses

"Medical Device Manufacturer License" and "Medical Device Product Registration Certificate" have registered address and production address bar. What's the difference between the two addresses?

The registered address refers to the record office address that the medical device manufacturer is prepared to use when registering, which is reflected in the business license and is subject to the management of the territorial drug administration, taxation, industry and commerce and other administrative departments. There can only be one registered address.

The production address is the specific production address of the medical device. It can be more than one, and all should be confirmed or certified by the relevant management. In China, the medical device production address and registration address are often the same, but many imported medical device registration address and production address are not the same, and even distributed in two different countries.

In the medical device registration management, the production address is more important than the registration address. According to the relevant provisions of the Medical Device Registration Management Measures, the registered address only needs to be changed even if there is a substantial change, but the production address needs to be re-registered if there is a substantial change. If the production address is only changed in a literal way, you only need to change it.

[Case Review]

A local drug administration found in an inspection that the CT machine product registration certificate used in District B hospital was licensed to a company in the United States, but the production address marked on the medical device label was in Israel. Is it legal? Can it be classified as a medical device without 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 limits of the product registration certificate. If the product registration certificate specifies the manufacturing address in Israel, such a device is obviously legal, but if the medical device is manufactured in the United States, it is not legal. If the specified manufacturing location is not in Israel, such products are unlicensed.

What content is restricted by the production address

The production of medical devices should be produced in strict accordance with the limited content of the product registration certificate. Similarly, medical device manufacturers using their own production or other factory parts assembly machine, should be in accordance with the registration certificate limited standards for inspection, inspection can be factory sales. The registration certificate limits the production address to the whole machine, not to each component. That is, the production address bar limits the address where the final assembly of the whole machine is completed.

[Case Review]

A local food and drug administration found in the inspection that the production address marked by the label of a digital X-ray imaging system used by a hospital in the jurisdiction is consistent with the address limited by the product registration certificate, but the production address of its component parts is displayed in the United States, the detector label shows the production address in Germany, and the high-frequency high-voltage generator label shows the production address is China. Can such a medical device be characterized as a medical device without a product registration certificate?

The limitation of the production address of the product registration certificate is for the address of the final assembly into the whole machine, and is not the limitation of the production address of each component. It is lawful to purchase parts from other factories or other countries for the production of medical devices, except for parts managed as medical devices, such parts should be licensed by the licensing authority at the time of registration, or obtain a separate product registration certificate. Therefore, the medical device in this case cannot be characterized as a medical device without a product registration certificate.

Import equipment production address identification

Article 6 of the Regulations on the Management of Medical Device Instructions, Labels and Packaging Marks stipulates that the text content of overseas medical device instructions, labels and packaging marks must be in Chinese, and other languages can be added. Article 5, Article 15 of the Provisions on the Management of Medical Device Instructions, Labels and Packaging Labels and Article 48 of the Measures for the Management of Medical Device Registration stipulate that its content should be consistent with the relevant contents of the medical device registration certificate and instructions reviewed by the State Food and Drug Administration. The production address is one of the limited contents of the product registration certificate. If the production address marked on the medical device label or manual is inconsistent with the product registration certificate address, the medical device without product registration certificate can be punished.

In November 2008, the State Food and Drug Administration issued the "Notice on Overseas Medical Device Labels and packaging Labeling Issues", clearly: "Overseas medical device manufacturers in accordance with international trade rules, in some of their imported medical device labels and packaging marks marked in the country of origin, such as' Madeinxx (country) 'and similar expressions, may be inconsistent with the Chinese label and packaging marks in the' production site address/production address 'marked by the country, This situation does not violate the relevant provisions of Order No. 16 and Order No. 10 of the Bureau."

It can be seen that medical devices can be manufactured by outsourcing parts, and the country or production address marked by the parts can be inconsistent with the address specified in the product registration certificate. Only when the production address of the complete medical device is changed, it can be characterized as a violation of Article 48 of the Measures for the Registration and Administration of Medical Devices.

[Case Review]

An imported medical device label marked "madeinGermany", product registration certificate limited production address in the United States, the address marked on the Chinese label and product registration certificate limited production address consistent. Is such a device an unlicensed medical device?

As mentioned earlier, in accordance with the notice of the State Food and Drug Administration, the "madeinxx (country)" that is inconsistent with the product registration certificate is legal when it refers to the production country of the part. If the whole machine is indeed "madeinxx (country)" marked on the label, such medical devices should be characterized as medical devices without product registration certificate. In order to further prove that "madeinxx (country)" refers to the production address of the whole machine or the production address of the parts, the inspectors can ask for the qualification certificate of imported medical devices, packing list, invoice and customs clearance, commodity inspection report to confirm.

Consignment production address identification

Article 34 of the Measures for the Supervision and Administration of Medical Device Production stipulates that: "For medical devices commissioned for production, their instructions, labels and packaging labels shall indicate the name of the entrusting party, the name of the entrusted party and the production address." At this time, the medical device is marked with the production address of the trustee, which is inconsistent with the production address specified in the product registration certificate held by the client.

This behavior does not violate the provisions of Articles 34 and 38 of the Measures for the Registration and Administration of Medical Devices, and in accordance with the principle of "special is superior to general", commissioned production applies to the Measures for the Supervision and Administration of Medical Device Production, rather than the Measures for the Registration and Administration of Medical Devices.

[Case Review]

A local food and drug administration found in the inspection that the B glucose meter manufacturer marked the production address of the C factory in the production address column of the product registration certificate. After investigation, it was found that the enterprise where the address was located was the partner of the manufacturer of the B blood glucose meter. C manufacturer accepts the commissioning of B manufacturer to produce blood glucose meter. At the time of registration, the provincial food and Drug Administration where the manufacturer is located will also include the address of the entrusted manufacturer in the product registration certificate. If Factory B entrusts other manufacturers to produce blood glucose meters, is such a blood glucose meter a change of production address and can it be characterized as a medical device without product registration certificate?

Some products are prepared for registration before the registration of commissioned production, at this time the product registration certificate cannot include the address of the trustee into the production address column of the product registration certificate. The commissioned production of medical devices does not fall under the circumstances provided for in Article 12 of the Administrative Licensing Law, but meets the provisions of Article 13 of the Administrative Licensing Law: "Where the matters listed in Article 12 of this Law can be regulated by the following means, no administrative license may be established: (1) Where citizens, legal persons or other organizations can independently decide... (4) The situation can be solved by the administrative organ using other administrative management methods such as post-supervision."

Commissioned production is a matter independently decided by the enterprise, and the administrative organ can adopt post-supervision and other methods to ensure the safety and effectiveness of medical devices. Commissioned production of medical devices does not require administrative approval, only registration and filing. Changes in commissioned production only need to be reported, without administrative approval. Since there is no need for administrative approval, the address of the trustee should not be included in the address bar of the production site in the product registration certificate.

In the above case, which enterprise is commissioned by Factory B to produce the blood glucose meter is the independent choice of the enterprise and does not need the permission of the regulatory authorities. If enterprise B entrusts manufacturers other than Factory C (in accordance with the relevant laws and regulations of commissioned production) to produce blood glucose meters, it only needs to do a good job of filing, which is a legal behavior.