1. Purpose
In order to implement the relevant requirements of the State Food and Drug Administration for the management of medical device classification, guide the applicants for the classification and definition of medical devices to fill in the application materials and supplementary materials (hereinafter referred to as the application materials), according to the “General Office of the General Administration of Medical Devices “Notice on Relevant Work” (Food and Drug Administration Office [2017] No. 127) and other relevant regulations, compiling this reporting guide.
2. Scope of application
Applicants for the classification and definition of domestic and foreign medical device products fill in the application materials online.
3. Fill in pathway
The applicant logs on to the website of “National Institute for Food and Drug Control (National Food and Drug Administration Medical Device Standard Management Center)” (https://www.nifdc.org.cn), and enters the “Office Hall” — “Medical Classification Management”–“Medical Device Classification and Definition Information System” page, submit application materials online.
When logging into the system for the first time to apply for classification and definition, you must first register according to the system prompts, fill in relevant information and upload files online according to the prompts and requirements.
4.Data requirement
Classification definition application materials should be filled in according to the actual product to ensure that the application materials are legal, authentic, accurate, complete and traceable. When filling out the information, pay attention to the following aspects:
Data completeness
(1).Submit materials in accordance with the “Notice of the General Office of the General Administration on Standardizing the Work Related to the Classification of Medical Device Products” (Food and Drug Administration [2017] No. 127), and the content can be added if necessary. See Annex 1 for a list of submissions.
(2). Fill in the list of documents and materials in the order of the list of materials, please refer to Appendix 2.
(3). When uploading the first application materials and supplementary materials in the information system, upload the scanned copy of the signed document and the corresponding Word version file at the same time.
(4). The relevant materials such as marketing certificates and manuals of overseas products have original texts and Chinese translations.
Data standardization
The content in the application registration form can reflect the complete situation of the product, and other information is the refinement and supplement of the application registration form.
(1). Classification definition application registration form. The content of the form should be clear and complete, see Appendix 3 for details.
(2). Product manual. It should be the product instructions to be marketed, and the main content should in principle meet the requirements of the “Regulations on the Administration of Medical Device Instructions and Labels” (China Food and Drug Administration Order No. 6).
(3). Product photos (videos may be included). Product photos (including videos) are clear and complete, can fully express the internal and external components contained in the applied product, and can reflect the whole process of product use.
(4). Product technical requirements. It should be the product technical requirements of the products to be listed. In principle, the technical indicators in the application materials are the same as those of the later-listed products. Where the technical terms of the national standard or industry standard are adopted, the implementation date and standard number of the standard shall be indicated.
(5). Proof of overseas listing. For products whose application source is “overseas”, the overseas listing certificate of the product shall include key information such as the management category of the country of origin and the validity period of the document.
(6). Evidential materials. There are clear evidence materials for key contents such as working principle, mechanism of action and main risk points.
(7). All materials are signed and sealed, and paper documents are stamped with a seam seal.
Data consistency
The content of all materials should be consistent, and if there is any content conflict, the submitted data will be invalid.
(1). Key information such as product name, structural composition, function and use in each document should be consistent.
(2). For overseas products, the content of the marketing certificate, manual, technical requirements and other documents, the Chinese translation and the original text should be consistent.
(3). The functions, uses and other information of accessory products should be consistent with the corresponding content of the supporting host.
(4). The information in the paper version of the application materials and the electronic system should be consistent.
(5). The signature and seal of all materials should be consistent with the name of the applicant.