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Principle for dividing for the registered units of in vitro diagnostic reagent
1 Basic principle
1.1 The registered units of in vitro diagnostic reagent shall be a single reagent or a single reagents kit, and one unit can include the different kinds of packing specification of one product.
1.2 Calibrator and control material which are used in concert with the in vitro diagnostic reagent can be registered with the reagent, they also can be registered separately.
2 Specific conditions
2.1 Single reagents kit is the existence form which includes all or partial reagents that can be used to complete one test or one type test. Single reagent refers to all independent reagents in the kit. As required, the single reagents kit and single reagent can be one registered unit for registering. The class of the single reagents kit can be sure according with the highest usage of its intend use. The class of the single reagent can be sure according with its intend use.
2.2 These are many different kinds of packing specification for one detection kit. The difference between the different packing specifications of detection kit is just a discrepancy for packing amount or test amount. Such as: micro-albumiuria diagnostic kit (immuno-scatter turbidmetry) has two kinds packing specifications: 30T and 50T.
2.3 These are many different kinds of packing specification for one detection kit. In addition to difference of packing amount or test amount of packing specifications, the detection kit in different forms for different type of instrument or product form. Difference in type of instrument: such as micro-albumiuria diagnostic kit (immuno-scatter turbidmetry) has two kinds packing specifications: 30T and 50T, and the different packing specifications for different type of instrument respectively. Difference in form of product: such as morphine diagnostic kit (colloidal gold), includes two kind forms, bar type and card type.
2.4 The product which is named after the indications name that refers to the product or the other replacement name, is used for specific indications or application, and exists as a group which includes multiple kits for different substances. Then the product can be a registered unit. Such as: the combined test kit for HBsAg, Anti-HBs, HBeAg, Anti-HBe and Anti-HBc(Colloidal Gold), is used for detecting the HBsAg, Anti-HBs, HBeAg, Anti-HBe and Anti-HBc in human serum and human plasma. Substances in the polynomial detection kit shall be limited to the substances which have diagnostic significance of aided diagnosis for specific indications.
2.5 The polynomial detection kit which is made up of a different combination can be a registered unit. The combination is restricted to the reaction system is independent and immiscible of items. Such as morphine gold conjugate test strip, include five single diagnosis strip and three or five single diagnosis of joint inspection card. For the product itself, no matter joint inspection or separation, the reaction system of each test is relative independent and non-interfering, and these is no difference in performance of test. If the product is registered as a unit, the registration applicant shall submit all the technical data of five single diagnosis strip which can cover all the products. For the joint inspection kit with different combinations, the product can be name after the indication name which refers to the product. For example, if the joint inspection cards which include five and three single diagnosis respectively are registered as a unit the product can be named multiple joint inspections diagnostic kit for narcotics (colloidal gold). As another example, multiple inspections diagnostic kit (chip hybridization) is used for detecting the objects by PCR methods. If the name of the single diagnostic kit cannot consistent with the name of multiple inspections diagnostic kit, it suggests that they do not be registered as a unit.
2.6 Calibrator and control material can be registered with the corresponding reagent as a unit. For example, C-reactive protein detection kit (transmission turbidimentry), the kit not only includes detection reagents but also the corresponding calibrator. Calibrator and control material can be registered a separate unit, such as control material of C-reactive protein. In the same unit, the calibrator and control material can be at different level. The same unit can include the kits, that one includes calibrator and control material and one does not.
3 The other problems of the dividing
3.1 There are unified product name and label in the same unit.
3.2 If the registered product applies to change of registration, the content is limited to the relative content which is got in the registration unit of medical device registration certificate, cannot exceed the items of the registration unit or change registration unit. For example, the multiple inspections diagnostic kit with a different combination, cannot increase usage by applying change of registration. The content of change is limited to the relevant content which is approved in the registration. If the registration unit does not include calibrator and control material, the calibrator and control material cannot be added by applying to change of registration.
3.3 The in vitro diagnostic reagent and in vitro diagnostic devices cannot be registered as a unit.
Principle for dividing for the registered units of in vitro diagnostic devices
1 Basic principle
According to article 74 of Administrative Measures for Medical Device Registration, the products can be registered as a unit, if the product name and technique principle are same, structures are different, and application and performance are similar.
2 Fulfill any of the following conditions, they cannot be registered as a unit
2.1 The product name is same, but the technique principle is different.
For example: the automated chemiluminescence immunoassay analyzer. The products with different technique principle, one uses direct chemiluminescence assay principle, another one uses indirect chemiluminescence assay principle, so they cannot be registered as a unit.
2.2 The product name, technique principle and application are same, but the electric safety performance is different, which is caused by different internal circuit design.
For example: automated culturing system. In order to meet the demands of cultivating different number of bacteria, it needs to design different internal circuit. And the different electric safety performance is caused by different internal circuit design. Therefore the medical devices cannot be cannot be registered as a unit under this condition.
2.3 The product name, technique principle and application are same, but the index performance is different, which is caused by different structures.
For example: automatic medical PCR analysis system. The product has two types, the single and the double colored real-time fluorescence PCR analysis system, respectively. They cannot be registered as a unit because the index performance is different.
2.4 Modular automatic biochemical-immune analyzer. The product has two types, the single and the whole function modular automatic biochemical-immune analyzer. They cannot be registered as a unit.
For example: Modular automatic biochemical-immune analyzer. If the analyzer misses biochemical or immune module, then the product has only single functional module, shall be named “automatic biochemical analyzer” or “automatic immune analyzer”. Because the names are different, so single and the whole function modular automatic biochemical-immune analyzer cannot be registered as a unit.
In addition, if one product just adds the number of the biochemical or immune module with the same model to increase detection throughput, and the product name, technique principle and application are consistence with the whole function modular automatic biochemical-immune analyzer, so they can be registered as a unit in this condition.
2.5 If one or more items of the technique principle, structures, application and performance have changed of the registered product, then the product is not in the same unit before and after changed. So the product must be registered as a new product, and cannot be changed according with licensing items alteration.
