關(guān)閉
Recently, NMPA has been undergoing a major overhaul. The "Classification Catalog of In Vitro Diagnostic Reagents" was released. (Click to view details: Registration is affected, IVD reagent classification rules have changed) This is also a traditional performance of NMPA. Regulations are always issued before get off work on weekends, so that everyone can use weekend time to study and think seriously without delaying work. Therefore, don’t let NMPA’s good intentions go to waste. Today I will talk to you about what has been changed in the classification catalog this time, and how to spend this time of regulatory changes.
This change in the classification catalog is based on the "In Vitro Diagnostic Reagents Classification Rules", and the classification rules were actually released at the end of October 21, which is nearly two and a half years ago. During this period, the classification catalog still used the "6840 In Vitro Diagnostic Reagents Classification Sub-Catalogue (2013 Edition)", which had many conflicts with the "Classification Rules". For example, there is a big gap in structure. The structure of the "Classification Sub-Catalogue" is composed of five parts: serial number, product category, product classification name, intended use and management category, which is inconsistent with the current medical device classification catalog. The structure of the "Classification Catalog" is composed of six parts: first-level serial number, first-level product category, second-level serial number, second-level product category, intended use, and management category. The structure is in line with the medical device classification catalog. Among the first-level product categories, there are a total of 25 categories, which is 3 more than the product categories in the "Classification Sub-Catalog". I made a comparison between the two, as shown in the table below.
| 6840 In vitro diagnostic reagent classification subcatalog (2013 version) In vitro diagnostic reagent classification catalog | |
| III-1 Reagents related to the detection of pathogenic pathogen antigens, antibodies and nucleic acids | Reagents related to the detection of pathogenic pathogen antigens, antibodies and nucleic acids Test-related reagents (Class I) |
| III-2 Reagents related to blood group and tissue matching | Reagents related to blood group and tissue matching (Category III) |
| III-3 Reagents related to human genetic testing | Reagents related to human genetic testing (Class III) |
| III-4 Reagents related to genetic diseases | Reagents related to genetic diseases (Class III) |
| III-5 Reagents related to testing of narcotic drugs, psychotropic drugs, medical toxic drugs and narcotic drugs | Reagents related to testing of narcotic drugs, psychotropic drugs, medical toxic drugs and narcotic drugs (Class III) |
| III-6 Reagents related to therapeutic drug target detection | Reagents related to therapeutic drug target detection (Class III) |
| III-7 Reagents related to tumor marker detection | Reagents related to tumor marker detection (Class III) |
| II-1 Reagents for protein detection | Reagents for protein detection (Class II) |
| II-2 Reagents for carbohydrate detection | Reagents for sugar detection (Class II) |
| II-3 Reagents for hormone detection | Reagents for hormone detection (Class II) |
| II-4 Reagents for enzyme detection | Reagents for enzyme detection(Class II) |
| II-5Reagents for ester detection | Reagents for ester detection(Class II) |
| II-6Reagents for vitamin testing | Reagents for vitamin testing(Class II) |
| II-7Reagents for inorganic ion detection | Reagents for inorganic ion detection(Class II) |
| II-8Reagents for detection of drugs and drug metabolites | Reagents for detection of drugs and drug metabolites(Class II) |
| II-9Reagents for autoantibody detection | Reagents for autoantibody detection(Class II) |
| II-10Reagents for microbial identification or drug susceptibility testing | Reagents for microbial identification or drug susceptibility testing and cell culture media for cell selection, induction, and differentiation(Class II) |
| III-8Reagents related to allergies (allergens) | Reagents related to allergies (allergens)(Class II) |
| II-11Reagents for testing other physiological, biochemical or immune function indicators | Reagents for testing other physiological, biochemical or immune function indicators(Class III) |
| I-1Microbial culture medium (not used for microbial identification and drug susceptibility testing) | Microbial culture medium without microbial identification and drug susceptibility identification and cell culture medium used only for proliferation(Class I) |
| I-2Products for sample processing | Products for sample processing(Class I) |
| General reagents for reaction systems(Class I) | |
| III-9 Reagents related to flow cytometry | Single antibody reagents and isotype control antibodies for flow cytometry that provide only auxiliary diagnostic information |
| Single antibody reagents for immunohistochemistry that provide only auxiliary diagnostic information | |
| Single probe reagents for in situ hybridization that provide only auxiliary diagnostic information | |
From the table, we can see that the changes in most categories are very small. The biggest changes are reagents related to flow cytometry technology, which have been directly changed from three categories to one category. But there is also a gap here. Single antibody reagents and isotype control antibodies are managed as a category. If they are to be used in combination with antibodies, they are still managed as a second or third category. This time, the "Classification Definition" not only adjusted the writing method and classification level, but also revised the intended use. Therefore, registrants still need to conduct a detailed comparative analysis based on their own product lists and categories to avoid huge losses caused by omissions.
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