1. Drafting background
The classification of medical devices (including in vitro diagnostic reagents) in my country implements the classification catalog system under the guidance of classification rules. Classification rules and classification catalogs coexist, and the classification catalog takes precedence.
Different from the “Medical Device Classification Rules”, the Bureau did not issue the classification rules of in vitro diagnostic reagents as a separate document before, but wrote the relevant content in the “Notice on Printing and Distributing the Administrative Measures for the Registration of In Vitro Diagnostic Reagents (Trial)” (National Food and Drug Administration [2007] No. 229) and the Measures for the Administration of 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 No. 5 was stripped to form an independent “Rules for the Classification of In Vitro Diagnostic Reagents” (hereinafter referred to as the “Rules”) document.
2. Main content
The full text of the “Rules” consists of ten articles.
Article 1 explains the purpose of the “Rules”. Articles 2 and 3 respectively define the product scope of in vitro diagnostic reagents and the scope of application of the Rules.
The fourth article refers to the IMDRF classification principles and adds the main factors affecting the degree of product risk.
Article 5 clarifies the overall principles for the category determination of in vitro diagnostic reagents based on my country’s regulatory practice and referring to the IMDRF classification principles.
Articles 6 and 7 are based on the classification rules in Order No. 5, referring to the IMDRF classification principles, and according to the actual classification of in-vitro diagnostic reagents in recent years, the specific rules and special regulations for the classification and determination of in-vitro diagnostic reagents are clarified. Compared with the classification rules in Order No. 5, the main revisions include:
（1）. According to the “Notice of the General Office of the State Food and Drug Administration on the Implementation of the First Class Medical Device Filing Matters” (Food and Drug Administration [2014] No. 174, hereinafter referred to as No. 174), it is only used for cell proliferation culture , does not have the functions of selection, induction and differentiation of cells, and the cultured cells are used for in vitro diagnostic cell culture medium as the first type of in vitro diagnostic reagents.
（2）. According to Document No. 174 and the actual classification of in vitro diagnostic reagents, the examples of sample processing products have been revised, and nucleic acid extraction reagents have been added as the first category of in vitro diagnostic reagents.
（3）. According to Circular No. 226 and the actual classification of in vitro diagnostic reagents, “general reagents for the reaction system, such as buffer solution, substrate solution, enhancement solution, etc.” are defined as 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, which has the functions of selection, induction and differentiation of cells, and the cultured cells are used for in vitro diagnostics” is added as the second category of in vitro diagnostic reagents.
（5）. According to Circular No. 226, the reagents used for allergy (allergen) detection are specified as the second category of in vitro diagnostic reagents.
（6）. In order to better guide the classification of new products such as companion diagnostics, the reagents for companion diagnostics are defined as the third category of in vitro diagnostic reagents, and the description of reagents for companion diagnostics is added with reference to relevant documents of IMDRF, EU and FDA.
（7）. According to the actual classification of in vitro diagnostic reagents, referring to the IMDRF classification principles and EU classification related documents, the “reagents related to tumor marker detection” in Order No. 5 was changed to “reagents related to tumor screening, diagnosis, auxiliary diagnosis, staging, etc. reagents”.
（8）. According to Circular No. 226 and the actual classification of in vitro diagnostic reagents, it is clear that antibody reagents for flow cytometry, antibody reagents for immunohistochemistry and probe reagents for in situ hybridization, and lymphoid reagents for flow cytometry have definite diagnostic value. Cell subgroup analysis kits shall be managed as Class II or Class III in vitro diagnostic reagents in accordance with Article 6 of the “Rules” according to their intended clinical use; Antibody reagents, single antibody reagents for immunohistochemistry, single probe reagents for in situ hybridization, and isotype control antibody reagents for flow cytometry are managed as Class I in vitro diagnostic reagents.
（9）. According to the actual classification of in-vitro diagnostic reagents, the newly added “products for sample processing in the first category of in-vitro diagnostic reagents listed in Article 6, if they are non-general-purpose products, or participate in the reaction and affect the test results, should be related to the corresponding test reagents. The management category is the same.”
Articles 8 and 9, in accordance with the new “Regulations” and “Measures for the Administration of Registration and Filing of In Vitro Diagnostic Reagents”, with reference to Order No. 15, clarified the formulation and adjustment of the classification catalog of in vitro diagnostic reagents, and the confirmation of newly developed product categories.
Article 10 stipulates the implementation time and principles. In order to link up with the newly revised “Regulations for the Registration and Filing of In Vitro Diagnostic Reagents” and other supporting links, the “Rules” will be officially implemented from the date of issuance. After the implementation of the “Rules”, if the classification principles of in vitro diagnostic reagents in the previously issued documents are inconsistent with the “Rules”, the “Rules” shall prevail.
3. Others
Previously released catalogs related to the classification of in vitro diagnostic reagents, such as “6840 In Vitro Diagnostic Reagent Classification Subcatalogue (2013 Edition)” “Announcement on Adjusting Part of the <6840 In Vitro Diagnostic Reagent Classification Subcatalog (2013 Edition)” (National Drug Administration Bureau Announcement No. 112 of 2020) and the attachments of Announcement No. 226 “Product Classification List of In Vitro Diagnostic Reagents for Flow Cytometry”, “Classification List of In Vitro Diagnostic Reagent Products for Immunohistochemistry and In Situ Hybridization” and “Products Not Managed as Medical Devices” “List” will continue to be effective until the revision of the classification catalog of in vitro diagnostic reagents is issued.