I. Background of drafting
The classification for medical devices (including in vitro diagnostic reagents) in China implements the classification catalog system under the guidance of classification rules, and classification rules and classification catalogues coexist to give priority to classification catalogues.
Unlike Classification Rules for Medical Device, the Bureau did not publish Classification Rules for In vitro Diagnostic Reagent as a separate document, but rather included the relevant contents in the Notice on the Administration of registration for In vitro Diagnostic Reagents (Trial) (No. 229 State Drug Administration (2007)) and Measures to the Registration for In vitro Diagnostic Reagents (Decree No.5 State Drug Administration, hereinafter referred to as Decree No. 5).
In accordance with the deployment on regulatory document revision work supporting "Regulations on Supervision and Administration for Medical Devices", the contents of classification for in vitro diagnostic reagent in Decree No. 5 will be stripped, forming an independent document " Classification Rules for In vitro Diagnostic Reagent " (hereinafter referred to as the "Rules").
II. Main content
There are ten articles in the full text of the Rules.
Article 1 explains the purpose of the Rules. Article 2 and Article 3 identify the scope of products for in vitro diagnostic reagents and the application scope of the Rules respectively.
Article 4 refers to the classification principle of IMDRF, newly adding main factors affecting product risk level.
Article 5 identifies the general principle of category determination for in vitro diagnostic reagents, based on China's regulatory practice, with reference to the classification principle of IMDRF.
Article 6 and Article 7 identify specific rules and special provisions of classification determination for in vitro diagnostic reagents on the basis of classification rules in Decree No. 5, with reference to the classification principle of IMDRF, and in accordance with the practices of classification for in vitro diagnostic reagents in recent years. The main modifications include:
1. It is identified to be used only for cell proliferation culture, not having the function of cell selection, induction, differentiation, and the cultured cells being used as in vitro diagnostic cell medium, class I in vitro diagnostic reagents, according to the Notice of Office of State Food and Drug Administration on Matters Related to Implementation of the Filing for Class I Medical Devices (MMOFDA [2014] No. 174, hereinafter referred to as Document No. 174).
2. The examples of products used for sample processing have been modified, and nucleic acid extraction reagents have been added as class I in vitro diagnostic reagents according to Document No. 174 and the practices of classification for in vitro diagnostic reagents.
3. “General reagents of reaction system, such as buffer, substrate fluid, enhancer liquid” are identified as class I in vitro diagnostic reagents according to Announcement 226 and the practices of classification for in vitro diagnostic reagents.
4. "Cell medium for cell proliferation culture, which has the function of selecting, inducing and differentiating cells, and cultured cells for in vitro diagnosis" is added as class II in vitro diagnostic reagent according to the practices of classification for in vitro diagnostic reagents.
5. Reagents specifically used for the detection of allergens (allergens) are identified as class II in vitro diagnostic reagents according to Announcement 226.
6. In order to better guide the classification for new products such as accompanying diagnosis, accompanying diagnostic reagents are identified as class III in vitro diagnostic reagents, with reference to relevant documents of IMDRF, European Union and FDA, adding new description of accompanying diagnostic reagents.
7. "Reagents related to tumor marker detection" in Decree No.5 are modified to "reagents related to tumor screening, diagnosis, auxiliary diagnosis, staging, etc." according to the practices of classification for in vitro diagnostic reagents., with reference to classification principles of IMDRF and relevant documents of EU classification,
8. According to Announcement 226 and classification, it is identified that antibody reagent for flow cytometry, immunohistochemistry antibody reagent and probe reagent for in situ hybridization and lymphocyte subgroup analysis kit for flow cytometry with clear diagnostic value, in accordance with their clinical intended use, shall be managed according to class II or class III in vitro diagnostic reagents respectively per Article 6 in the Rules; Single antibody reagent for flow cytometry, single antibody reagent for immunohistochemistry, single probe reagent for in situ hybridization and homotypic control antibody reagent for flow cytometry, which only provide auxiliary diagnostic information for professional physicians, shall be managed according to class I in vitro diagnostic reagent.
9. According to the practices of classification for in vitro diagnostic reagents., "Sample treatment products in class I in vitro diagnostic reagents listed in Article 6, if non-generic products, or participating in the reaction and influencing test results, shall be consistent with management category of the corresponding test reagents" is added.
Article 8 and Article 9 identify the catalogue formulation, adjustment of in vitro diagnostic reagents classification and confirmation of newly developed products classification, according to new Regulations and Measures for Registration and Filing of In vitro Diagnostic Reagents, with reference to Decree No. 15.
Article 10 identifies the time and principle of implementation. In order to connect with the newly revised Measures to Registration and Filing for In vitro Diagnostic Reagents, the Rules have been put into effect since the date of publication. After the implementation of the Rules, if the principle of classification for in vitro diagnostic reagents in previously published documents is inconsistent with the Rules, the Rules shall prevail.
III. Others
Previously published catalogues related to classification for in vitro diagnostic reagent, such as 6840 In vitro Diagnostic Reagent Classification Subdirectory (version 2013) and Announcement on the Adjustment of the parts of < 6840 In vitro Diagnostic Reagent Classification Subdirector (version 2013) > (No. 112, Announcements of State Drug Administration in 2020) and Annex No. 226 to the List of Product Classifications for In vitro Diagnostic Reagents for Flow Cytometers, List of Product Classifications for In vitro Diagnostic Reagents for Immunohistochemistry and In situ Hybrids, List of Products not for Medical Device Management continue to be valid until the revision of classification catalog for in vitro diagnostic reagent is published.
Related links
Announcement of State Drug Administration on the Publication of the Rules for Classification for In vitro Diagnostic Reagents (No. 129 in 2021) 2021-10-29
Source: State Drug Administration
The classification for medical devices (including in vitro diagnostic reagents) in China implements the classification catalog system under the guidance of classification rules, and classification rules and classification catalogues coexist to give priority to classification catalogues.
Unlike Classification Rules for Medical Device, the Bureau did not publish Classification Rules for In vitro Diagnostic Reagent as a separate document, but rather included the relevant contents in the Notice on the Administration of registration for In vitro Diagnostic Reagents (Trial) (No. 229 State Drug Administration (2007)) and Measures to the Registration for In vitro Diagnostic Reagents (Decree No.5 State Drug Administration, hereinafter referred to as Decree No. 5).
In accordance with the deployment on regulatory document revision work supporting "Regulations on Supervision and Administration for Medical Devices", the contents of classification for in vitro diagnostic reagent in Decree No. 5 will be stripped, forming an independent document " Classification Rules for In vitro Diagnostic Reagent " (hereinafter referred to as the "Rules").
II. Main content
There are ten articles in the full text of the Rules.
Article 1 explains the purpose of the Rules. Article 2 and Article 3 identify the scope of products for in vitro diagnostic reagents and the application scope of the Rules respectively.
Article 4 refers to the classification principle of IMDRF, newly adding main factors affecting product risk level.
Article 5 identifies the general principle of category determination for in vitro diagnostic reagents, based on China's regulatory practice, with reference to the classification principle of IMDRF.
Article 6 and Article 7 identify specific rules and special provisions of classification determination for in vitro diagnostic reagents on the basis of classification rules in Decree No. 5, with reference to the classification principle of IMDRF, and in accordance with the practices of classification for in vitro diagnostic reagents in recent years. The main modifications include:
1. It is identified to be used only for cell proliferation culture, not having the function of cell selection, induction, differentiation, and the cultured cells being used as in vitro diagnostic cell medium, class I in vitro diagnostic reagents, according to the Notice of Office of State Food and Drug Administration on Matters Related to Implementation of the Filing for Class I Medical Devices (MMOFDA [2014] No. 174, hereinafter referred to as Document No. 174).
2. The examples of products used for sample processing have been modified, and nucleic acid extraction reagents have been added as class I in vitro diagnostic reagents according to Document No. 174 and the practices of classification for in vitro diagnostic reagents.
3. “General reagents of reaction system, such as buffer, substrate fluid, enhancer liquid” are identified as class I in vitro diagnostic reagents according to Announcement 226 and the practices of classification for in vitro diagnostic reagents.
4. "Cell medium for cell proliferation culture, which has the function of selecting, inducing and differentiating cells, and cultured cells for in vitro diagnosis" is added as class II in vitro diagnostic reagent according to the practices of classification for in vitro diagnostic reagents.
5. Reagents specifically used for the detection of allergens (allergens) are identified as class II in vitro diagnostic reagents according to Announcement 226.
6. In order to better guide the classification for new products such as accompanying diagnosis, accompanying diagnostic reagents are identified as class III in vitro diagnostic reagents, with reference to relevant documents of IMDRF, European Union and FDA, adding new description of accompanying diagnostic reagents.
7. "Reagents related to tumor marker detection" in Decree No.5 are modified to "reagents related to tumor screening, diagnosis, auxiliary diagnosis, staging, etc." according to the practices of classification for in vitro diagnostic reagents., with reference to classification principles of IMDRF and relevant documents of EU classification,
8. According to Announcement 226 and classification, it is identified that antibody reagent for flow cytometry, immunohistochemistry antibody reagent and probe reagent for in situ hybridization and lymphocyte subgroup analysis kit for flow cytometry with clear diagnostic value, in accordance with their clinical intended use, shall be managed according to class II or class III in vitro diagnostic reagents respectively per Article 6 in the Rules; Single antibody reagent for flow cytometry, single antibody reagent for immunohistochemistry, single probe reagent for in situ hybridization and homotypic control antibody reagent for flow cytometry, which only provide auxiliary diagnostic information for professional physicians, shall be managed according to class I in vitro diagnostic reagent.
9. According to the practices of classification for in vitro diagnostic reagents., "Sample treatment products in class I in vitro diagnostic reagents listed in Article 6, if non-generic products, or participating in the reaction and influencing test results, shall be consistent with management category of the corresponding test reagents" is added.
Article 8 and Article 9 identify the catalogue formulation, adjustment of in vitro diagnostic reagents classification and confirmation of newly developed products classification, according to new Regulations and Measures for Registration and Filing of In vitro Diagnostic Reagents, with reference to Decree No. 15.
Article 10 identifies the time and principle of implementation. In order to connect with the newly revised Measures to Registration and Filing for In vitro Diagnostic Reagents, the Rules have been put into effect since the date of publication. After the implementation of the Rules, if the principle of classification for in vitro diagnostic reagents in previously published documents is inconsistent with the Rules, the Rules shall prevail.
III. Others
Previously published catalogues related to classification for in vitro diagnostic reagent, such as 6840 In vitro Diagnostic Reagent Classification Subdirectory (version 2013) and Announcement on the Adjustment of the parts of < 6840 In vitro Diagnostic Reagent Classification Subdirector (version 2013) > (No. 112, Announcements of State Drug Administration in 2020) and Annex No. 226 to the List of Product Classifications for In vitro Diagnostic Reagents for Flow Cytometers, List of Product Classifications for In vitro Diagnostic Reagents for Immunohistochemistry and In situ Hybrids, List of Products not for Medical Device Management continue to be valid until the revision of classification catalog for in vitro diagnostic reagent is published.
Related links
Announcement of State Drug Administration on the Publication of the Rules for Classification for In vitro Diagnostic Reagents (No. 129 in 2021) 2021-10-29
Source: State Drug Administration