Sfyjxqbh [2016] No. 63
Issued on September 21, 2016
Food and drug administrations of all provinces, autonomous regions and municipalities directly under the central government and relevant units:
In order to implement the work requirements of the opinions of the State Council on reforming the review and approval system of drugs and medical devices (GF [2015] No. 44), further do a good job in the classified management of in vitro diagnostic reagents, and scientifically and reasonably determine and divide the attributes and categories of some in vitro diagnostic reagents, the food and drug administration has organized the drafting of allergens The classification principles of flow cytometry supporting and immunohistochemical in vitro diagnostic reagents, and put forward specific classification and attribute definition opinions for the mastered specific product classification:
1、 Allergen in vitro diagnostic reagents
Reagents related to allergy (allergen), including total IgE detection reagents and specific IgE antibody detection reagents, are managed as class III medical devices.
2、 In vitro diagnostic reagent for flow cytometry
（1） Products managed as the third category of in vitro diagnostic reagents include:
1. Reagents for the diagnosis of leukemia and lymphoma;
2. Reagents for polychromatic lymphocyte subsets analysis;
3. Reagents related to genetic disease detection;
4. Reagents related to the detection of tumor markers;
5. Reagents related to tissue matching test;
6. Reagents related to the detection of therapeutic drug action targets;
（2） Products managed as class I in vitro diagnostic reagents include:
1. Sample processing reagent for flow cytometry;
2. Running reagent for flow cytometry;
3. Calibration reagent for flow cytometry.
（3） In addition to being identified as class I and class III in vitro diagnostic reagents, other in vitro diagnostic reagents supporting flow cytometry are managed as class II in vitro diagnostic reagents, mainly including:
1. Reagent for soluble cytokine detection;
2. Reagent for intracellular cytokine detection;
3. Reagents for autoantibody detection;
4. Reagents for other physiological, biochemical or immune function indicators.
（4） Flow cytometry supporting products that are not managed as in vitro diagnostic reagents include:
1. There is no single antibody reagent with clear clinical intended use;
2. Reagents for quality control of plasma or blood components;
3. Reagents that are only used for cell therapy related tests and have no other intended clinical uses;
Note: for those produced by enterprises that are expected to be tested jointly by multiple single antibody reagents and have clear clinical intended use, they should be declared and registered as a registration unit according to medical devices. Refer to articles 1, 2 and 3 of this Clause for specific classification.
3、 Immunohistochemical in vitro diagnostic reagents
（1） Products managed as the third category of in vitro diagnostic reagents include:
1. Reagent with intended use including medication guidance;
2. Reagents intended for the diagnosis of tumors or genetic diseases;
（2） As the second type of in vitro diagnostic reagent management, it includes:
In addition to other immunohistochemical in vitro diagnostic reagents managed as the third type of in vitro diagnostic reagents. For example:
1. Reagent for immunological staining based on routine staining to provide cell differentiation information for pathologists' diagnosis;
2. Reagents for auxiliary diagnosis of complement related immune diseases.
（3） Products not managed as in vitro diagnostic reagents include:
Without clear intended use, clinicians select, combine and test reagents according to actual needs during clinical diagnosis, and do not directly issue diagnostic results.
Note: if such reagents are declared to have definite intended use, they shall be declared and registered as medical devices. Refer to articles 1 and 2 of this article for specific classification.
See Annexes 1 to 3 for the list of specific products.
Now please organize the research on the above classification and attribute definition principles and product list, put forward specific modification opinions, and feed back the opinions to the device registration department of the food and drug administration before October 31, 2016. At the same time, the above classification and attribute definition principles and product list are also open to other relevant units in the society for comments.
mail box: [email protected] 。 When sending an email, please indicate "classification and attribute adjustment of some reagents" in the subject of the email.
Letter: device registration department, food and drug administration, building 2, yard 26, Xuanwumen West Street, Xicheng District, Beijing 100053.
Annex: 1 Recommended adjustment table for product classification and attributes of allergen in vitro diagnostic reagents
2. Recommended adjustment table for product classification and attributes of in vitro diagnostic reagents for flow cytometry
3. Recommended adjustment table for product classification and attributes of immunohistochemical in vitro diagnostic reagents (please click "read the original text" in the lower left corner to view the attachment)
Device registration department of food and Drug Administration
September 19, 2016
