Preamble

The purpose of this guideline is to help and guide the registration applicant to prepare the registration declaration of single-use intravenous needle (hereinafter referred to as intravenous needle), and also to provide reference for the technical review department.

This guideline is the general requirements for the registration of intravenous needles, the applicant should be based on the characteristics of specific products to enrich and refine the content of the registration information. The applicant for registration may also be based on the characteristics of the specific product to determine whether the specific content is applicable, and if not applicable, need to specify the reasons and the corresponding scientific basis.

Scope of application

This guideline applies to the insertion of the human peripheral vascular venous system, with the appropriate infusion apparatus for use, for infusion/infusion of fluids, blood collection of indwelling needles, the product can be left in the venous vasculature for a period of time. This guideline does not apply to arterial indwelling needles and dialysis indwelling needles.

Key points for registration review

The application form for the declared product, the list of products, records of previous communications, master file authorisation letter (if applicable) and other regulatory information should be accurately completed.

The structure and composition of the application form should list the structural components of the product as well as the raw material information of the main components (e.g. catheter components, etc.) (plasticisers and/or light-absorbing agents contained in the raw materials should also be specified), special performance components (e.g. anti-needle-stick devices), single-use, and sterilisation methods (radiation sterilisation should be used, and the type of radiation should also be clarified).

Product list should list the product model, specifications, structure and composition, accessories, as well as the identification of each model specification (such as model or part number, unique identification of the device, etc.) and description of the description (such as size, material, etc.). It is recommended to list the above contents in the form of a table.

This guideline applies to endovascular intravenous indwelling needles under the classification code 14-02-07 in the Catalogue of Medical Devices Classification, and the management category is Class III.

The product name should be in line with the requirements of the ‘Naming Rules for Common Names of Medical Devices’, while referring to the ‘Guidelines for Naming Common Names of Injection, Nursing and Protective Devices’, national standards, industry standards, etc. The product name should be in Chinese. The product name should be in Chinese, not a mixture of English and Chinese.

Declaration of product registration unit division needs to be based on the ‘Medical Device Registration and Record Management Measures’, ‘Medical Device Registration Unit Division Guiding Principles’ requirements, focusing on the consideration of the product's principle of operation, structural composition, raw materials of the main components and other factors, such as:

(1) The raw materials (including plasticisers) of the main components of catheters and extension tubes of the products need to be divided into different registration units.

(2) Indwelling needles claiming to be light-safe and non-light-safe needles need to be divided into different registration units.

Product Technical Requirements

The product should comply with the applicable mandatory national/industry standards currently in force, while the applicant for registration is also required to develop product technical requirements in accordance with the ‘Guiding Principles for the Preparation of Technical Requirements for Medical Devices’ and other relevant regulations, combined with product design features and clinical applications.

(1) Product model / specification and its division description

Clearly define the product model / specification, clarification of the model / specification of the division between the description of the model / specification expression needs to be consistent with the other registration declaration information. Declare the product model, specification division as far as possible using national standards, industry standards for the identification of methods, should be able to cover all the components of the product, the material, the corresponding relationship is clear, do not use ‘series’, ‘etc.’ ambiguous terms. Recommend the use of diagrams and/or tables.

List the structure of the product, such as the inclusion of special performance devices should also be listed in the structure of the diagram, if necessary, also need to list the sectional drawings.

Information on the raw materials used for the components of the product, including the medical material standards or grades for components that come into direct or indirect contact with blood.

List the sterilisation method and shelf life of the product. (Can also be placed in the appendix)

(2) Performance indicators

The applicant for registration may refer to YY/T 1282 ‘Disposable Intravenous Needles’ to develop product performance indicators and test methods. If the indexes and test methods of the above standards are not adopted, it is recommended to provide detailed reasons for not adopting them and validated supporting information, including source basis and/or methodological validation information.

For products with other special properties or special structure, in addition to the above performance also need to formulate the corresponding performance requirements based on product characteristics. For example, the performance indicators of the infusion interface can refer to the YY/T 0581 series of standards to develop the corresponding performance indicators, claiming that the performance of light-sheltered intravenous needles can refer to YY 0286.3 ‘special infusion set Part 3: single-use light-sheltered infusion set’ to develop the relevant performance indicators and so on.

(3) Test methods

The test methods of the products shall be set according to the technical performance indexes, and the test methods shall give priority to the methods in the national standards/industry standards. For products applicable to the national standards / industry standards do not apply to the provisions, need to explain the reasons for inapplicability. All references to the standard specify its number or year. Self-defined test methods need to provide the appropriate methodological basis and theoretical basis, while ensuring that the test method is operable and reproducible, if necessary, need to provide methodological verification information.

Clinical evaluation

If the product does not meet the requirements of the Catalogue, or can not prove the basic equivalence with the product has been approved for domestic registration, it is necessary to submit clinical evaluation information in accordance with the requirements of the ‘Technical Guidelines for Clinical Evaluation of Medical Devices’.