Registration of blood dialyzers 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 blood dialyzer products that comply with the industry standard YY 0053, which covers blood dialyzers, blood dialysis filters, blood filters, and blood concentrators used for blood dialysis and related treatments.
Key points for registration review
Clinical evaluation data for blood dialyzers should be provided in accordance with the format and content specified in the “Technical Guidelines for Clinical Evaluation of Medical Devices” and other relevant documents. Although blood dialyzers are not currently exempted from clinical evaluation, companies should follow the guidelines to submit the required clinical evaluation data.
Product labeling, instructions, and packaging should comply with the YY 0053 regulatory standard for medical device instructions and labeling management, as well as other applicable standards. The product instructions should clearly state the scope of application, maximum transmembrane pressure, contraindications, precautions, sterilization methods, performance parameters, and expiration date. The scope of application should align with the conclusions of the clinical evaluation and national regulatory requirements. It is recommended to include a statement specifying that the product should be used in accordance with relevant operational guidelines and regulations and is restricted to trained medical personnel.
Quality management system documentation should provide a brief overview of the working principles and overall production processes of the blood dialyzer. It should include information on the product design process and production procedures, which can be presented in the form of flowcharts. Additionally, the documentation should include the addresses and contact information of all manufacturers of the device or its components. If applicable, it should also provide the names and addresses of important suppliers involved in outsourced production, critical components or materials production (such as animal tissues and drugs), key process procedures, and sterilization.
Further information
Read the original CMDE amended technical review guidelines for the registration of blood dialyzers 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.
