CFDA sought advice on the classification and adjustment of three types of in-body diagnostic reagents, such as allergens

Food and Drug Administration of provinces, autonomous regions and municipalities directly under the Central Government, relevant units:
In order to implement the Work requirements of the State Council on the Reform of the Drug Medical Device Review and Approval System (Guofa (2015) No. 44), further do a good job in the classification management of in-body diagnostic reagents, scientifically and reasonably determine and divide some in-body diagnostic reagent properties and categories, the General Administration of Food and Drug Administration has drafted allergens The principles of classification of in-body diagnostic reagents with flow cytometers and immunogasics, and the specific product classifications that have been mastered are put forward for specific classification and attribute definition opinions: I. Allergen inostroviral diagnostic reagents
and reagents related to perverted reactions (allergens), including general IgE test reagents, specific IgE anti-medical reagents, as a third type of medical device management.II, flow cytometer supporting in-body diagnostic reagents(i) as a third type of in-body diagnostic reagent management products, including:
1. reagents for leukemia and lymphoma diagnosis;
2. for multicolor lymphocyte sub-group analysis reagents;
3. Reagents related to genetic disease detection;
4. Reagents related to tumor marker detection;
5. Reagents related to tissue matching testing;
6. Reagents related to therapeutic drug target testing; (ii) as the first class of in-body diagnostic reagents management products, including:
1. Flow cytometer supporting sample processing reagents;
2.flow cytometer supporting the operation of reagents;
3. Flow cytometer supporting calibration reagents.(iii) In addition to the in-body diagnostic reagents that have been clearly identified as the first and third categories, other flow cytometers are used as in-body diagnostic reagents for the second type of in-body diagnostic reagent management, including:
1. Soluble cytokine detection reagents;
2. Reagents for cytokine detection;
3. Reagents for autoantibodies detection;
4. Reagents for testing other physiological, biophysic or immune function indicators.(iv) Flow cytometer companion products not managed as in-body diagnostic reagents, including:
1. Single antibody reagents with no clear clinical intended use;
2. Reagents for blood plasma or component blood quality control;
3. Reagents for cell therapy-related testing only and no other clinically intended use;
Note: For enterprise production, it is expected that multiple single antibody reagents will be tested jointly, and if there is a clear clinical intended use, registration shall be reported as a medical device as a registration unit. Specific classification refers to Articles 1, 2 and 3 of these Terms.III. Immune histogeneic diagnostic reagents(i) as a third type of in-body diagnostic reagent management products, including:
1. Expected use contains drug guidance reagents;
2. The intended use is to identify reagents for the diagnosis of tumors or genetic diseases;(ii) to be managed as a second type of in-body diagnostic reagent, including:
in addition to other immunogasmed in-body diagnostic reagents managed as a third type of introphy diagnostic reagent. Such as:
1. Immunosty staining on the basis of conventional dyeing, reagents to provide cell differentiation information for pathologist diagnosis,
2. Reagents for complementary immune diseases auxiliary diagnosis.(iii) Products not managed as in-body diagnostic reagents, including:
have no clear intended use, clinicians in clinical diagnosis according to the actual needs of the selection, combination and testing, not directly issued diagnostic results of reagents.
: For such reagents, if they are declared to have a clear intended use, they shall be declared and registered as medical devices, with reference to Articles 1 and 2 of these Terms.
list of specific products can be found in annexes 1 to 3.
now request your unit to organize a study on the above classification and attribute definition principles, product list, put forward specific amendments, and by October 31, 2016 will be feedback to the Food and Drug Administration
General Administration of Equipment Registration Division. At the same time, the above classification and attribute definition principles, product lists are also open to other relevant units of society for comments.
email:
ylqxzc@sina.cn
. When sending a message, please indicate "Partial reagent classification and attribute adjustment" at the subject of the message.
: Beijing Xicheng Xuanwumenxi Street, 26th Floor, Food and Drug Administration Equipment Registration Division, zip code: 100053. (State Administration of Food and Drug Administration)