[The court]
A Bureau of the supervision and inspection of the registered agent for Company C, B-type ultrasonic diagnostic apparatus imported medical equipment used in hospital B label marked. Product registration certificate provided by the supplier of the B-type ultrasonic diagnostic apparatus Attachment medical devices registration table "marked the registered agent for D Company. After verification, the B-type ultrasonic diagnostic apparatus product registration card the limited registration agency does D Company.
[Differences]
The unauthorized alterations qualified registered agency for product registration card, so how the medical equipment qualitative differences inspectors:
The first opinion: should be characterized as the product registration certificate of medical devices. Medical Device Registration "(Board Order No. 16) and the provisions of Article 52:" medical devices registered products means be allowed to register their brochures, labels, packaging and labeling, and other relevant content is limited to the medical device registration certificate consistent product. "The B-the qualified D company in the product registration certificate becomes C Company, does not comply with the provisions of that section, that does not belong to a registered product, in other words the product registration certificate of medical devices.
The second opinion: can not be classified as medical devices product registration certificate. The registration of the product for the product, the registration agency, both D Company or C Company, does not bring substantive changes will give the medical equipment itself. Registration agency changes do not affect the safety and efficacy of the device itself, it can not be characterized as a product registration certificate of medical devices.
[D]
What is register the product?
Article VIII of the Medical Devices Regulations stipulates: "The State shall implement a product registration system of medical devices. "Measures for the Administration of Registration of Medical Devices" (the "Measures") provides: "sales in the People's Republic of China, the use of medical devices in accordance with the provisions of this approach should be applied for registration, and not be allowed to register medical devices may not be sold, and used. "Medical Device Registration" Article 53 stipulates: "The production of medical devices within the validity period of the certificate of registration of medical devices are deemed to have certified products. "
It can be concluded that the registered products should be produced within the validity period of the certificate of registration of medical devices, and qualified medical devices and packaging and labeling, labels and product registration certificate products.
The case of B-type ultrasonic diagnostic apparatus registered agency with limited registration certificate registered agent has changed. According to the provisions of Article 52 of the Measures, the B-type ultrasonic diagnostic apparatus in the present case is not a registered product.