Interpretation of "In Vitro Diagnostic Reagent Classification Rules"

1.
Drafting background

The classification of medical devices (including in vitro diagnostic reagents) in China implements a classification catalog system under the guidance of classification rules.
Classification rules and classification catalogs coexist, and classification catalogs are preferred
.

Unlike the "Medical Device Classification Rules", our bureau did not publish the in vitro diagnostic reagent classification rules as a separate document.
Instead, the relevant content was written into the "Notice on Issuing the Registration Management Measures for In Vitro Diagnostic Reagents (Trial)".
(State Food and Drug Administration [2007] No.
229) and "Administrative Measures for the Registration of In Vitro Diagnostic Reagents" (State Food and Drug Administration Order No.
5, hereinafter referred to as Order No.
5)
.

In accordance with the deployment of the revision of the supporting regulations and normative documents of the "Regulations on the Supervision and Administration of Medical Devices", the content related to the classification of in vitro diagnostic reagents in Order 5 was stripped to form an independent "In Vitro Diagnostic Reagent Classification Rules" (hereinafter referred to as the "Rules") document
.

2.
Main content

There are ten articles in the full text of the "Rules"
.

The first article explains the purpose of the "Rules"
.

The fourth article refers to the IMDRF classification principle, and adds the main factors affecting the degree of product risk
.

Article 5 is based on China’s regulatory practice and with reference to the IMDRF classification principles to clarify the general principles for the classification of in vitro diagnostic reagents
.

Articles 6 and 7 are based on the classification rules in Order 5, referring to the IMDRF classification principles, and based on the actual work of in vitro diagnostic reagent classification in recent years, to clarify the specific rules and special regulations for the classification and determination of in vitro diagnostic reagents
.

1.
According to the "Notice of the General Office of the State Food and Drug Administration on Matters Concerning the Implementation of the Filing of Class I Medical Devices" (Food and Drug Administration Office No.
[2014] No.
174, hereinafter referred to as No.
174), it is clearly only used for cell proliferation and culture , Does not have the function of cell selection, induction, and differentiation, and the cell culture medium used for in vitro diagnosis of cultured cells is used as the first type of in vitro diagnosis reagent
.

2.
According to Circular 174 and the actual classification of in vitro diagnostic reagents, the examples of products used for sample processing have been modified, and nucleic acid extraction reagents have been added as the first type of in vitro diagnostic reagents
.

3.
According to the No.
226 Announcement and the actual classification of in-vitro diagnostic reagents, it is clear that "general reagents for the reaction system, such as buffers, substrate solutions, enhancement solutions, etc.
" are the first category of in-vitro diagnostic reagents
.

4.
According to the actual classification of in vitro diagnostic reagents, "cell culture medium used for cell proliferation and culture, selection, induction, and differentiation of cells, and cultured cells used for in vitro diagnosis" is newly added as the second category of in vitro diagnostic reagents
.

5.
According to Circular 226, the reagents used for allergy (allergen) detection are specified as the second type of in vitro diagnostic reagents
.

6.
In order to better guide the classification of new products such as companion diagnostics, clarify that companion diagnostic reagents are used as the third type of in vitro diagnostic reagents, and refer to relevant IMDRF, EU and FDA documents, and add descriptions of companion diagnostic reagents
.

7.
According to the actual classification of in vitro diagnostic reagents, referring to IMDRF classification principles and relevant European Union classification documents, the "reagents related to tumor marker detection" in Order 5 is revised to "related to tumor screening, diagnosis, auxiliary diagnosis, staging, etc.
"Reagents"
.

8.
According to the 226th Announcement and the actual classification of in vitro diagnostic reagents, it is clear that antibody reagents for flow cytometry, antibody reagents for immunohistochemistry, probe reagents for in situ hybridization, and lymphocytes for flow cytometry have a clear diagnostic value.
Cell subpopulation analysis kits are managed in accordance with the second or third type of in vitro diagnostic reagents in accordance with the provisions of Article 6 of the "Rules" according to their clinical intended use; a single flow cytometer that only provides auxiliary diagnostic information for professional doctors Antibody reagents, single antibody reagents for immunohistochemistry, single probe reagents for in situ hybridization, and isotype control antibody reagents for flow cytometry are managed in accordance with the first category of in vitro diagnostic reagents
.

9.
According to the actual situation of the classification of in vitro diagnostic reagents, a new "product for sample processing in the first category of in vitro diagnostic reagents listed in Article 6, if it is a non-universal product, or participates in the reaction and affects the test result, should be combined with the corresponding test reagent Management categories are the same
.

Articles 8 and 9 are based on the new "Regulations" and "In Vitro Diagnostic Reagent Registration and Filing Management Measures", with reference to Order 15, clarifying the formulation and adjustment of the in vitro diagnostic reagent classification catalog and the confirmation of newly developed product categories
.

Article 10 stipulates the implementation time and principles
.

Three, other

Previously released catalogs related to the classification of in-vitro diagnostic reagents, such as the "6840 in-vitro diagnostic reagent classification sub-catalog (2013 edition)" "Announcement on the adjustment of some contents of the <6840 in-vitro diagnostic reagent classification sub-catalog (2013 edition)>" (National Drug Administration Bureau Announcement No.