NMPA classifies medical devices into three levels (Class Ⅰ, Class Ⅱ, and Class Ⅲ) based on their risk. Determining the classification of a medical device is an important step before the start of a registration process. Because product classification is related to various aspects such as the follow-up of document preparation, testing projects, and clinical evaluation pathways. If the product registration was rejected by NMPA due to the manufacturer’s initial misjudgment of product classification, it will eventually lead to the whole registration failure. If such, the manufacturer has to re-make registration document, re-obtain the test report, and submit it again, which will waste a lot of time, expense, and labor costs, and even lead to lose valuable opportunities to compete with competitors in the market.
Therefore, precisely determining the classification of a product and making an appropriate registration strategy before its registration is crucial.
Required Documents and Time for Product Classification Delimitation
Application for medical product classification requires the submission of product master documents to NMPA (National Medical Products Administration, formerly CFDA), along with an application form.
After the application is submitted, the NMPA may provide additional documentation based on product requirements. It is also not excluded that there will be several communications with NMPA in order for NMPA to make a final decision. For products that are relatively easy to classified, the review time is usually around four months (not including the time required to prepare submission materials).
Regulatory Basis
The classification of medical devices refers to the “Rules for the Classification of Medical Devices (Order No. 15 of the China Food and Drug Administration)”, the “Classification Catalogue of Medical Devices (No. 104 of 2017)” and the relevant regulatory documents of classification issued later. For example, the “Announcement of the National Medical Products Administration on the Adjustment of the Medical Device Classification Catalogue (No. 25 in 2022)”, the “Announcement of the National Medical Products Administration on the Management Category of Medical Sodium Hyaluronate Products (No. 103 in 2022)”, the “Announcement of the National Medical Products Administration on the Release of the Class Ⅰ Medical Device Product Catalogue (No. 158 in 2021)”, etc.
The classification of in vitro diagnostic reagents is based on the “Announcement of the Classification Rules for in vitro diagnostic Reagents (No. 129, 2021)” issued by National Medical Products Administration. Previously published related catalogs to in-vitro diagnostic reagent classification, such as “6840 In-vitro Diagnostic Reagent Classification Sub-catalog (2013 edition)”, “Announcement About Adjusting Part of the <6840 In-vitro Diagnostic Reagent Classification Sub-catalog (2013 edition)> (Announcement No. 112 of 2020 by the National Medical Products Administration)”, “Announcement of NMPA on the Adjustment of Product Attributes and Categories of In-vitro Diagnostic Reagents for Allergens, Flow Cytometry, Immunohistochemistry and in situ Hybridization (No.226 of 2017)”, appendix “In-vitro Diagnostic Reagent Product Classification List for Flow Cytometry”, “In-vitro Diagnostic Reagent Product Classification List for Immunohistochemistry and in situ Hybridization”, “Not as a Medical Device Management Product List”, are still effective before the release of the revised in-vitro diagnostic reagent classification catalogue.
You can go to the official website of the “Medical Device Standard Management Center of National Medical Products Administration—Office Hall—Medical Device Standards and Classification Management—Information Disclosure” to search current effective classification definition results, and determine the classification of new products not included in the classification catalog. You can refer to the category of the predicate device of the new product if the new one is not classified. If there are no predicate devices with defined results, you can apply for classification and definition according to the detailed working process of the “Notice of the General Office of the General Administration of the State Council on Regulating the Work Related to the Classification of Medical Device Products (Food and Drug Administration (2017) No. 127)”. If the new product is initially judged as Class Ⅲ according to the classification standards, you can directly apply for the registration of Class III medical devices, and check the option of “equivalent to Class Ⅲ” in the registration application form. If you directly apply for the registration of Class III medical devices, NMPA will then determine corresponding category of your product according to its risk degree. If the domestic medical device is determined to be Category II or Category I, the NMPA will inform the applicant to apply for registration or filing with the corresponding medical products administration.
