Registration of Blood Dialysis Concentrates 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 aim to provide regulatory guidance for applicants preparing and writing registration application materials for blood dialysis concentrates and serve as a reference for technical evaluation departments.
The guidelines apply to blood dialysis concentrates that comply with the industry standard YY 0598 “Blood Dialysis and Related Treatment Concentrates.” They outline the general requirements for registration application materials, which should be tailored based on the specific characteristics of the product. The guidelines are not legally binding and should be used in compliance with relevant regulations. If alternative methods meet regulatory requirements, detailed research and validation data must be provided. The content of the guidelines may be adjusted as regulations, standards, and scientific knowledge evolve.
Key points for registration review
- Regulatory Information:
- Product names should adhere to the naming rules for medical devices and guidance principles for naming transfusion, dialysis, and extracorporeal circulation devices.
- Describe the general name of the declared product and its determination basis.
- Provide documents such as product lists, previous communication records, authorization letters (if applicable), and compliance statements.
- Describe the product’s working principle, mechanism of action (if applicable), chemical materials, and supply status, highlighting unique features distinguishing it from similar products.
- Specify model specifications, including composition, functions, product features, and technical parameters.
- Provide packaging information, including details of containers directly in contact with the concentrate.
- Present the research background, purpose, and references to similar or predecessor products if applicable.
- Non-clinical Data:
- Provide product risk management documents, considering components, clinical usage methods, and potential clinical risks.
- Include a list of potential hazards such as non-compliant chemical materials, ion concentration, insoluble particles, inappropriate shelf life, adverse reactions between chemicals and packaging, and microbial or chemical contamination.
- Conduct risk analysis, evaluation, control, acceptability assessment, and overall risk assessment in relation to the benefits of the product.
- Present the medical device safety and performance principles checklist, explaining how the concentrate meets the applicable requirements and providing supporting documentation.
- Comply with the product technical requirements specified in relevant guidelines and standards.
- Study Data:
- Provide non-clinical research summaries, detailing the conducted studies, methods, and conclusions. Emphasize research on design validation, process validation, technical features, and production processes.
- Describe research on product performance, including determination of performance indicators and the selected standards or methods.
- Provide stability and packaging studies to demonstrate the product’s shelf life and suitability for storage and transportation conditions.
- Submit any additional studies necessary to prove safety and efficacy.
- Clinical Evaluation Data:
- Although blood dialysis concentrates are not included in the exempted medical devices list, provide clinical evaluation data following the guidelines for clinical evaluation of medical devices.
- Comply with the required format and content specified in relevant documents.
- Product Information and Labeling:
- Ensure compliance with regulations such as the management rules for medical device instructions and labels and YY 0598.
- The product’s scope of use should be clearly stated, along with the composition of different models, A/B agent combinations, dosage, final dialysis fluid ion concentration, shelf life, pH value, volume of water required for powder dissolution (if applicable), and clinical application parameters for online use of B powder.
- Clarify the pairing relationship between A and B agents and specify their use in conjunction with specific products.
- Provide quality management system documents, including a brief overview of the product’s working principle, overall production process, and quality control standards.
Read the original CMDE amended technical review guidelines for the registration of blood dialysis concentrates 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.