Registration of disposable blood separation 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 scope of the guidelines applies to the registration of disposable blood separation devices used for separating blood components and includes devices such as arterial and venous puncture sets, blood component separation tubing, plasma separators, blood cell separators, and plasma separation cups. However, it does not apply to blood component storage devices, pathogen inactivation filters, membrane plasma separators, or autologous blood transfusion devices.
Key points for registration review
- According to the medical device classification catalogue, disposable blood separation devices fall under as Class III devices. The management category, classification code, and basis for product determination should be clearly identified and conformed to the blood separation, processing, and storage apparatus section (catalog item 02 for centrifugal blood component separators, item 03 for arterial and venous puncture devices used with blood component collection machines, and item 06 for plasma circuits).
- An accurate and complete product description should be provided including the product name, component names, materials used (with standardized chemical names), structure (with corresponding illustrations), intended use (clearly stating the intended blood component types and quantities for collection, separation, and processing), intended users (plasma stations, blood stations, or other facilities), intended scope of application (healthy donors, treatment patients), and active devices used in conjunction.
- Product’s model specifications and the basis for differentiation should be explained using a list format to describe the structure composition and performance indicators of different models, providing necessary illustrations for the differing parts.
Further information
Read the original CMDE amended technical review guidelines for the registration of disposable blood separation 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.
