Registration of disposable infusion devices in China shall refer to the newly revised technical review guidelines issued (No.15 of 2023) by the China Centre for Medical Devices Evaluation (CMDE) on April 28, 2023. These guidelines outline the general requirements for registration application materials, which should be tailored to the specific characteristics of the product.
Scope
The guidelines apply to certain categories of disposable infusion devices, such as those listed under the primary product categories 03-13, 10-02, 14-01, 14-02 of the medical device classification catalogue. The products are typically classified as Class II or III. Other related products may also refer to these guidelines.
Key point for registration review
- Registration Unit Division: Factors such as the working principle, structural composition, main component materials, performance indicators, and scope of application should be considered. Different registration units may be required for devices with different anti-needlestick structures, different materials for the main component “tubing,” or different structures for gravity infusion and non-gravity infusion products.
- Application Form: The application form should include a detailed description of the product’s structure, components, and material information. It should also specify the nominal pore size of the liquid filter, major additives (such as plasticizers), special performance components (e.g., self-destructive devices, anti-needlestick devices, liquid stoppers, air vents), attachments (such as infusion labels, which should be included in the primary packaging), single-use indication, sterilization method (specifying the type of radiation if applicable), and other relevant information.
Other important information
- Overview: Provide a comprehensive overview of the product, including its general name, determination basis, management category, applicable scope, delivery status, sterilization method, and background information. If applicable, provide an overview of the product’s background or specific details (e.g., history, previous submissions, relationships with approved products).
- Product Description: Include a detailed description of the product’s name, intended use, raw materials, working principle, structural composition (with corresponding illustrations), technical indicators, special features, division of model specifications, intended use, compliance with applicable mandatory standards, and performance modes.
- Packaging Information: Describe the packaging information for all products, including information about the sterile barrier system and/or packaging materials directly in contact with the product. Clarify how the integrity of the packaging is ensured, particularly if mandatory standards specify requirements for the primary packaging.
Further information
Read the original CMDE amended technical review guidelines for the registration of disposable infusion devices in China.
By adhering to the outlined requirements, manufacturers can ensure their products meet the necessary safety and performance standards. Also, Cisema can assist manufacturers in navigating the registration process effectively. Discover our services for medical device registration, renewals and NMPA Legal Agent.
