Notice of the State Food and Drug Administration on Matters Concerning the Implementation of the Classification Catalogue of In Vitro Diagnostic Reagents (No. 17 [2024])
In order to implement the requirements of the Regulations on the Supervision and Administration of Medical Devices (Order No. 739 of the State Council) and better guide the classification of in vitro diagnostic reagents, in accordance with the Administrative Measures for the Registration and Filing of In Vitro Diagnostic Reagents (Order No. 48 of the State Administration for Market Regulation) and the Announcement on the Issuance of the Classification Rules for In Vitro Diagnostic Reagents (Announcement No. 129 of 2021 of the State Drug Administration, hereinafter referred to as the "Classification Rules") and other relevant regulations, the State Food and Drug Administration organized the revision and release of the Classification Catalogue of In Vitro Diagnostic Reagents (hereinafter referred to as the "Taxonomy"). In order to do a good job in the implementation of the "Classification Catalog", the relevant matters are hereby notified as follows:
1. General Description
(1) The in vitro diagnostic reagents included in the Classification Catalogue refer to the in vitro diagnostic reagents managed according to medical devices, excluding the in vitro diagnostic reagents used for blood screening and in vitro diagnostic reagents labeled with radionuclides.
(2) The "Classification Catalogue" is based on the "Classification Rules" and compiled according to the characteristics of in vitro diagnostic reagents, and the structure of the "Classification Catalogue" 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", of which "first-level product category" is mainly established in accordance with the "Classification Rules", a total of 25; The "secondary product category" is a further refinement under the primary product category, which is mainly based on the detection target setting, and does not include methods or principles in principle, with a total of 1852; "Intended use" refers to the analyte and the main clinical use, etc., and its purpose is mainly to determine the management category of the product, and does not represent a complete description of the relevant product registration content. When applying for registration or filing, the name and intended use of the relevant product shall be implemented in accordance with the Administrative Measures for the Registration and Filing of In Vitro Diagnostic Reagents and related requirements.
The classification code continues to use 6840.
(3) Products with the same analyte but used in different intended uses in clinical practice and belonging to different management categories according to the Classification Rules, if they have a wide range of applications in different management categories, they shall be included in the corresponding management categories respectively in accordance with the Classification Rules, and the intended use description of the lower category items shall clearly not include the intended use managed by the higher category.
For products with multiple intended uses, but with the same management category according to the Classification Rules, when classifying the "first-class product category", priority will be given to the classification according to the clinical main use and specific use.
(4) According to Article 6 of the "Classification Rules", the medium used for microbial identification or drug susceptibility testing, as well as the cell culture medium used for cell proliferation culture, which has the functions of selecting, inducing and differentiating cells, and the cultured cells are used for in vitro diagnosis, shall be managed in accordance with the second category. Microbial culture medium that conforms to the "Classification Rules" and has a low risk and is only used for selective culture, and does not have the function of microbial identification and drug sensitivity, shall be managed according to the first category.
(5) In accordance with the cell culture medium managed in the first category, only basal medium products, such as RPMI-1640 medium, are retained, and the use restrictions are clarified according to the "Classification Rules" (not used for cell therapy, cell reinfusion, assisted reproduction and other non-in vitro diagnostic purposes).
(6) According to Articles 6 and 7 of the Classification Rules, the products used for sample processing managed in accordance with the first category mainly refer to the general products used in the sample pretreatment stage before the detection reaction occurs, and do not participate in the reaction. In principle, such products only include reagents for sample processing that are common to instrument platforms or methodologies, and do not include reagents for sample processing for specific testing items.
(7) The general reagents of the reaction system managed in accordance with the first category mainly refer to the general reagents that maintain the environment of the reaction system during the detection reaction stage. Only reagents with common instrument platforms or methodologies are included, and are not specific to specific test items. It is not possible to separate the complete product for registration/filing.
(8) The dyeing solution managed in accordance with the first category mainly refers to the general product, which does not contain specific proteins, antigens, antibodies, enzymes and other substances, and is named according to the main chemical composition or common name of the dyeing solution.
(9) According to the "Classification Rules", the antibodies or probes involved in flow cytometry, immunohistochemistry and in situ hybridization products managed in accordance with the first category are "single antibodies" or "single probes". Break gene probes and fusion gene probes for the detection of a single gene in in-situ hybridization products are regarded as "single probes" because of the characteristics of the product, which require two probes to complete the detection of a certain gene. In situ hybridization products for the detection of a single gene, in addition to the main specific probe, the composition of the product contains a probe that plays an "auxiliary positioning" role, which is regarded as a "single probe".
According to the Classification Rules, the combination of "single antibody" or "single probe" managed according to the first category described above is managed as the second or third category.
(10) In the "Classification Rules", "single antibody for flow cytometry that only provides auxiliary diagnostic information for professional doctors" refers to a single antibody and isotype control antibody that analyzes cells suspended in body fluids and provides auxiliary information. In vitro diagnostic reagents that form bioparticles by capturing other components in body fluids and then detect them by flow cytometry do not meet the relevant requirements of "single antibody for flow cytometry" in the "Classification Rules", such as reagents for the detection and analysis of interleukin, interferon, tumor necrosis factor and other substances based on antigen-antibody reactions on the flow cytometry platform, using specific "beads" or "microspheres" as carriers.
(11) Except for the circumstances listed in paragraph 2 of Article (9), if the intended use of a combination product not included in the Classification Catalogue is only a combination of the intended use of a single product, the management category shall be determined according to the highest management category of the individual product included. If there is a new intended use, it shall be classified and defined in accordance with the relevant requirements.
(12) The "Classification Catalogue" does not include calibrators and quality control products. According to the Classification Rules, the management categories of calibrators and quality controls used with Class II and Class III in vitro diagnostic reagents are the same as those of reagents. Calibrators and quality controls used with Class I in vitro diagnostic reagents are managed as Class II. Non-defined controls are not managed as medical devices.
(13) In accordance with the provisions of Articles 6 and 7 of the "Classification Rules", in vitro diagnostic reagents related to the detection of narcotic drugs, psychotropic drugs, and toxic drugs for medical use, and used in clinical institutions shall be managed according to Category III. The scope of narcotic drugs, psychotropic substances or toxic drugs for medical use shall be determined in accordance with the varieties of toxic drugs listed in the Catalogue of Narcotic Drugs and Psychotropic Substances and the Measures for the Administration of Toxic Drugs for Medical Use jointly issued by the State Food and Drug Administration, the Ministry of Public Security and the National Health Commission, as well as the varieties added in subsequent supplementary documents.
(14) According to the production, operation, and use of medical devices, based on the risk analysis and evaluation of medical devices, and in accordance with the "Working Procedures for Dynamic Adjustment of the Classification Catalogue of Medical Devices", update and adjust the "Classification Catalogue" in a timely manner.
(15) From January 1, 2025, the Notice of the Food and Drug Administration on Printing and Distributing the Classification Sub-Catalogue of In Vitro Diagnostic Reagents (Food and Drug Administration [2013] No. 242), the Notice on the Adjustment of Product Attributes and Categories of Allergens, Flow Cytometry, Immunohistochemistry and in Situ Hybridization in Vitro Diagnostic Reagents (Announcement No. 226 of 2017 of the State Food and Drug Administration) and the Adjustment of the Classification Sub-Catalogue of 6840 In Vitro Diagnostic Reagents (2013 Edition) The announcement of part of the content (Announcement No. 112 of 2020 of the State Drug Administration) (collectively referred to as the "original "Classification Catalogue") is repealed.
2. Relevant policies for the management of medical device registration and filing
(16) For in vitro diagnostic reagent registration certificates that have been approved and taken effect before January 1, 2025, they will continue to be valid within the validity period of approval.
(17) From January 1, 2025, for in vitro diagnostic reagents that apply for registration for the first time, the product registration application shall be accepted in accordance with the Classification Catalog.
For those who have accepted the first registration application before January 1, 2025 but have not yet made an approval decision, the drug regulatory department may continue to review and approve in accordance with the original Classification Catalog; If the registration is approved, if the adjustment of product management categories is not involved in accordance with the "Classification Catalog", the medical device registration certificate will be issued in accordance with the "Classification Catalog"; If the adjustment of product management categories is involved in the "Classification Catalog", the medical device registration certificate will continue to be issued in accordance with the original "Classification Catalog", and the product management category of the "Classification Catalog" shall be indicated in the remarks column of the registration certificate, and the validity period of the medical device registration certificate shall not exceed January 1, 2027.
(18) For the renewal of registration applications that have been accepted before January 1, 2025 but have not yet made an approval decision, the drug regulatory department shall continue to review and approve them in accordance with the original Classification Catalog; If the renewal of registration is approved, if the adjustment of product management categories is not involved in accordance with the "Classification Catalog", the medical device registration certificate will be issued in accordance with the "Classification Catalog"; If the adjustment of product management categories is involved in accordance with the "Classification Catalog", the medical device registration certificate will continue to be issued in accordance with the original "Classification Catalog", and the product management category of the "Classification Catalog" shall be indicated in the remarks column of the registration certificate, and the validity period of the medical device registration certificate shall not exceed January 1, 2027.
For medical device registration certificates that have been approved and taken effect before January 1, 2025, if the product management category is adjusted from a high category to a low category, the registrant shall apply to the corresponding drug regulatory department for renewal of registration or filing according to the changed category. If the drug regulatory department approves the renewal of registration, it shall issue a medical device registration certificate in accordance with the "Classification Catalog"; If the filing materials meet the requirements, the filing shall be handled; And indicate the number of the original medical device registration certificate in the remarks column of the registration certificate or the remarks column of the filing information form.
For medical device registration certificates that have been approved and have taken effect before January 1, 2025, if the product management category is adjusted from a low category to a high category, the registrant shall apply to the corresponding drug regulatory department for registration according to the changed category. If the registration application is submitted within the validity period of the original medical device registration certificate, if the registration certificate expires during the conversion of product categories, on the premise that the product is safe and effective and no serious adverse events or quality accidents occur after marketing, the registrant may apply to the original registration department for the extension of the original medical device registration certificate according to the original management category, and if it is extended, in principle, the validity period of the original medical device registration certificate shall not exceed January 1, 2027.
(19) For the application for change of registration that has been accepted before January 1, 2025 but has not yet made an approval decision, the drug regulatory department shall continue to review and approve it in accordance with the original Classification Catalog; If the change of registration is approved, if the adjustment of the product management category is not involved in accordance with the "Classification Catalog", the medical device change registration document will be issued in accordance with the "Classification Catalog"; If the adjustment of product management categories is involved in accordance with the "Classification Catalog", the medical device change registration documents will continue to be issued in accordance with the original "Classification Catalog", and the product management category of the "Classification Catalog" shall be indicated in the remarks column.
For medical device registration certificates that have been approved and have taken effect before January 1, 2025, if the management category adjustment is involved, if the registration change occurs during the validity period of the registration certificate, the registrant can apply to the original registration department for a change of registration. If the drug regulatory department approves the change of registration, it shall issue the registration document for the change of medical devices, and indicate the product management category of the "Classification Catalog" in the remarks column. The registrant shall apply for registration or filing with the corresponding drug regulatory department in accordance with the product management category of the Classification Catalogue. If the registration application is submitted within the validity period of the original medical device registration certificate, if the registration certificate expires during the conversion of product categories, on the premise that the product is safe and effective and no serious adverse events or quality accidents occur after marketing, the registrant may apply to the original registration department for the extension of the original medical device registration certificate according to the original management category, and if it is extended, in principle, the validity period of the original medical device registration certificate shall not exceed January 1, 2027.
(20) From the date of issuance of the Classification Catalogue to June 30, 2024, the filing of Class I in vitro diagnostic reagents may be handled in accordance with the original Classification Catalogue; Encourage the filing of Class I in vitro diagnostic reagents in accordance with the "Classification Catalog".
From July 1, 2024, the filing of Class I in vitro diagnostic reagents shall be handled in accordance with the Classification Catalog. For Class I in vitro diagnostic reagent products that have been filed before July 1, 2024, the filing person shall conduct a self-examination of the filing information and filing materials against the Classification Catalog. If it involves the change of filing or cancellation of filing, the filing person shall handle it in accordance with the Announcement on Matters Concerning the Filing of Class I Medical Devices (Announcement No. 62 of 2022 of the State Drug Administration). Among them, if the product category is adjusted from a low category to a high category in accordance with the Classification Catalog, the filing person shall apply to the corresponding drug regulatory department for registration in accordance with the provisions of the Administrative Measures for the Registration and Filing of In Vitro Diagnostic Reagents and the Classification Catalogue. From January 1, 2027, those who have not obtained a registration certificate in accordance with the law shall not be produced, imported and sold.
(21) If the products that have been registered or filed are not included in the "Classification Catalog", the applicant shall apply for classification and definition in accordance with the relevant requirements of the classification and definition of medical devices, and apply for registration or filing in accordance with the relevant provisions according to the classification and definition results.
(22) When handling the filing of Class I products, the specific composition of the product shall be clearly indicated, and alternative descriptions such as Component A, Component B, Component 1, Component 2 and so on shall not be used. For example, the dyeing solution products in the first product category 21 "products for sample processing".
3. Relevant policies for the filing of medical device production and operation licenses
(23) The medical device registrant and the entrusted manufacturer shall apply for a medical device production license or apply for a change in the production scope of the "Medical Device Production License" in accordance with the management category specified in the registration certificate of the in vitro diagnostic reagent product they produce, and the production scope of the "Medical Device Production License" shall be written in the form of "management category-6840 in vitro diagnostic reagents".
The medical device filing person and the entrusted manufacturing enterprise shall handle the production filing of the first class of medical devices in accordance with the filing information of the first class of in vitro diagnostic reagent products produced by the medical device for the record, and the production scope of the first class of medical device production record shall follow the writing method of "6840 in vitro diagnostic reagent".
(24) Medical device business enterprises shall, in accordance with the management category specified in the registration certificate of in vitro diagnostic reagent products, apply for a medical device business license or handle the second class of medical device business record, and the business scope of the medical device business license and the second class of medical device business record shall be written in the form of "6840 in vitro diagnostic reagent".
All provincial-level drug regulatory departments shall, in accordance with the unified deployment of the State Food and Drug Administration, organize and carry out the training, publicity and implementation of the "Classification Catalog" within the administrative area, supervise and guide the relevant units to implement the "Classification Catalog", and earnestly do a good job in the registration, filing, supervision and management of relevant products.
Notice is hereby given.
State Food and Drug Administration
May 10, 2024
Source: National Medical Products Administration
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