In order to standardize the application for classification and definition of medical devices in Beijing and improve the quality of the application data, according to the Regulations for the Supervision and Administration of Medical Devices (hereinafter referred to as the Regulations), Measures for the Administration of Registration and Filing of Medical Devices, Measures for the Administration of Registration and Filing of In-Vitro Diagnostic Reagents (hereinafter collectively referred to as the Measures), Rules for the Classification of Medical Devices, Rules for the Classification of In-Vitro Diagnostic Reagents (hereinafter collectively referred to as the Rules for Classification) , Classification Catalogue of Medical Devices, Product Catalog of Class I Medical Devices, Classification Catalogue of In Vitro Diagnostic Reagents (hereinafter collectively referred to as “Classification Catalogue”), as well as “Announcement of the State Drug Administration on the Standardization of Classification and Definition of Medical Devices Products” and other relevant requirements, this declaration requirement is hereby formulated.

I. Submit an application

The applicant logs in the “China Academy of Food and Drug Certification (State Drug Administration Medical Devices Standards Administration Center)” website (https://www.nifdc.org.cn), and enters the “Office Hall” --- “Medical Device Standards and Classification Management” --- “Medical Device Classification and Definition Information System” page in turn. “Medical Device Standards and Classification Management” - ‘Medical Device Classification and Definition Information System’ page, online submission of application information.

When logging into the system for the first time to apply for classification definition, you should register according to the system prompts, fill in relevant information and upload documents online according to the requirements.

II. Application materials

The list of application materials for classification definition is as follows:

1. Application form for classification definition of medical devices.

2. Product overview information. Active medical devices should describe the working principle, mechanism of action (if applicable), structure and composition, main functions and functions of its constituent parts (such as key components and software, etc.), product illustration (with details such as logo, interface, control panel, application part, etc.), and features distinguishing it from other similar products. Containing more than one component, should describe its connection or assembly relationship.

Passive medical devices should describe the principle of operation, mechanism of action (if applicable), structure and composition, raw materials (direct or indirect contact with the user and/or the patient's material components; if the device contains biological materials or derivatives, describe the source of the material and raw materials, the intended purpose of use, the main mode of action; if the device contains an active pharmaceutical ingredient or drug, describe the name of the drug, the intended purpose, the main mode of action, source), delivery status. (if the device contains active pharmaceutical ingredients or drugs, describe the name of the drug, the intended purpose of use, the main mode of action, source), the delivery status and sterilization (if applicable, describe the sterilization implementer, sterilization method, sterilization expiration date), the structural schematic diagrams and/or product illustrations, the use of the method and illustrations (if applicable), as well as the characteristics that distinguish the product from other similar products and other content.

In vitro diagnostic reagents should describe the working principle used by the product, product composition, source of raw materials and preparation methods, the main production process, test methods. Describe the clinical significance of the target to be detected, and provide references as support.

If the product has been applied for the definition of medical device classification, the applicant should explain the situation, and clarify the differences between the application information and the previous application information.

3. Product technical requirements. Product technical requirements in principle should be in accordance with the “Medical Device Product Technical Requirements Preparation Guidelines”, including product performance indicators and test methods.

4. Product photos or video. Product photos should be physical photos, including photos of the product in use, remove all the internal and external packaging samples after the physical photos and internal and external packaging photos. More than one model specifications, you can provide photos of typical products. Provide photos or videos of product use steps.

5. To be listed on the product specification. Application materials in the product specification, should be listed for use after the product specification, in principle, should be consistent with the “Medical Device Specifications and Labeling Regulations” and other relevant requirements. Has been listed outside the product, should provide the instructions listed outside.

6. Other technical information. For newly developed products not yet included in the “Classification Catalog”, or the expected use of the product is not included in the relevant classification to define the guiding principles, the “Classification Catalog” and other documents, should be submitted to the literature, clinical consensus, technical validation and other technical information, as well as clinical evaluation information (if any), to prove that the product has the claimed intended use. If the product as an accessory to the active product, should explain the host management category and the role played by the accessory.

7. Declaration of conformity. The applicant undertakes to submit the classification definition of the application information is legal, compliant, true, accurate, complete and traceable.

8. Supporting documents. Domestic applicants should provide a copy of the business license copy of the enterprise or institutional legal person certificate.

9. Authorized Power of Attorney. Application information, non-statutory representative or person in charge of the person himself, should be submitted to the “power of attorney”.

Third, the form of application information requirements

1. Application for classification and definition of complete and complete information, classification and definition of the application form is filled out.

2. Domestic product application information, such as no special instructions, should be signed by the applicant.

3. The application information should have a catalog, including the application information of the first and second level of the title, in the form of a table stating the page number of each item of information.

IV. Time limit for work

Since the receipt of the application for classification and definition of 20 working days to inform the classification and definition of the results, or to put forward the pre-categorization and definition of the views reported to the State Drug Administration Medical Devices Standards Administration Center. Expert consultation, communication and coordination of relevant departments and research advice, the applicant to supplement the information and other aspects of the time required is not calculated within the time limit for the definition of classification work.

Beijing Municipal Medical Device Review and Inspection Center (hereinafter referred to as the Municipal Device Review Center) since the receipt of the classification definition of the application information within 15 working days after the completion of the technical review work, issue a technical review opinion. If necessary, it can organize expert research. Need to correct the information, through the corrective information notification form to make corrective requirements, and once informed of the need to correct all the contents. The applicant shall, within 30 working days from the date of issuance of the notice of correction of classification definition, provide supplementary information in accordance with the requirements of the notice of correction at one time. If the applicant fails to submit the supplementary information after the deadline or the supplementary information does not meet the requirements, the application for classification and definition shall be returned in the classification and definition information system. The applicant may re-submit the application after completing the relevant application information.