Preamble

The purpose of this guideline is to help and guide the registration applicant to prepare the registration declaration of single-use sterile side hole blunt needles (hereinafter referred to as side hole blunt needles), in order to meet the basic requirements of the technical review. At the same time, it helps the review organisation to conduct a scientific and standardised review of this type of product and improve the quality and efficiency of the review work.

This guideline is the general requirements for the registration of blunt side-hole 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 should also be based on the characteristics of the specific product to determine whether the specific content is applicable, if not applicable, should specify the reasons and the corresponding scientific basis.

Scope of application

This guideline applies to the preparation of registration data and product technical review of side hole blunt needle reference.

Side hole blunt needle tip blunt and open in the side of the special injection needle, the function is to inject the gel filler (such as injectable sodium hyaluronate gel, etc.) into the skin and soft tissues in specific areas. The composition of the side hole blunt needle is the same as the ordinary injection needle, divided into the seat, the needle tube and the sheath part; the difference is that its tip is designed as a blunt shape in order to avoid piercing the blood vessels when entering the needle, such as right-angle blunt shape, closed arc blunt shape. The product should be aseptic independent packaging, single-use. Side-hole blunt needles are often used to puncture the skin or mucous membranes with skin-breaking needles in clinical use.

Registration Review Key-Points

According to the Catalogue for the Classification of Medical Devices, Side Hole Blunt Needle is classified as Class III medical device, classification code 14-01-06.

Explain the model specification of the product and the basis of classification, and make clear the difference of each model specification. The structural composition, specifications, dimensions and performance indicators of different models and specifications can be described in a list, or a schematic diagram can be used to express. Differences between different models, such as the type of wall of blunt needles, the length of the needle tube, the tip form should be listed in the comparison table.

Non-clinical information

The research data of the product should discuss the design of the declared product from the technical level, technical characteristics, control of raw materials (including the main material and all auxiliary materials such as additives, lubricants, adhesives, etc.) control, control and verification of the production process, process nodes with the possibility of the introduction of foreign substances to illustrate the product's performance indicators and the basis for the development of the packaging validation, verification of the sterilisation, validation, and other verification of the expiry date.

Risk information of products

In accordance with the requirements of GB/T 42062 ‘Medical Device Risk Management for Medical Devices’ standard, risk management is implemented throughout the product life cycle.

The applicant for registration shall point out any additional risks specific to the product to be declared, describing the method of risk analysis. Identified risks shall include at least, but not limited to, the following. See Appendix 1 for details.

The applicant for registration shall propose specific risk reduction measures for the identified risks. Reduce the risk of the declared product should be based on GB/T 42062 requirements from the design method, protective measures, safety information and other considerations. The applicant for registration shall manage the risk in the whole life cycle of the product so that the residual risk is within the acceptable range.

Product Technical Requirements

The applicant shall determine the functionality and safety indexes of the finished product in accordance with the provisions in the ‘Guidelines for the Preparation of Technical Requirements for Medical Device Products’, taking into account the technical characteristics of the product and clinical use. Product technical requirements should be clear specifications and models and their division of the description, product performance indicators and test methods, etc. It is recommended to provide product schematic diagrams, enlarged cross-sectional view of the side holes (indicating the end of the blunt needle, the length of the side holes, the width of the side holes and the end of the spacing between the side holes and the outer diameter of the syringe and the outer diameter, the width of the graduated line (if any)). Citation of national standards, industry standards, should ensure its applicability, and indicate the standard number, year number.

Side hole blunt needle performance studies

The applicant for registration shall provide product performance research information. Including effectiveness, safety indicators and other indicators related to quality control to determine the basis for the standards or methods used, the reasons for adoption and the theoretical basis. The use of all components of the product performance should be studied and verified, the results should be able to prove that meet the requirements of clinical use. Describe the blunt end form and design principle. Common performance research indicators include but are not limited to the terms of the technical requirements, for the fracture force and other items should also be carried out special research. If there are special design, performance and structure, corresponding research and verification information should be provided.

Biocompatibility evaluation study

The applicant shall conduct biological evaluation according to Table 1 of GB/T 16886.1 ‘Biological Evaluation of Medical Devices Part 1: Evaluation and Tests in the Risk Management Process’, and select the evaluation test items according to the use of the declared product, the use part and the exposure time, including at least: material-mediated thermogenicity, cytotoxicity, sensitisation reaction, intradermal reaction, and acute systemic toxicity.

Clinical evaluation information 

The Side Hole Blunt Needle is listed in the Catalogue of Medical Devices Exempted from Clinical Evaluation (hereinafter referred to as the Catalogue) in the Catalogue of Medical Devices Exempted from Clinical Trials. For the Side Hole Blunt Needle that meets the classification code 14-01-06 in the Catalogue, the registration applicant shall submit information on the comparison between the relevant information of the declared product and the contents described in the Catalogue and the comparison between the declared product and the medical devices in the Catalogue that have been approved for domestic registration.