Physicochemical characterization of nanomaterials used in medical devices encompasses the evaluation of various properties such as chemical composition, size distribution, morphology, surface characteristics, and crystalline structure. The China Centre for Medical Devices Evaluation (CMDE) released (No.15 of 2023) the physicochemical characterization requirements for medical devices that incorporate or consist of nanomaterials on April 28, 2023.
Importance of physicochemical characterization
Physicochemical characterization plays a crucial role in assessing the safety and efficacy of medical devices using nanomaterials. It encompasses the evaluation of various properties such as chemical composition, size distribution, morphology, surface characteristics, and crystalline structure. The significance of physicochemical characterization is reflected in different aspects of the application and registration process, as outlined below.
Regulatory information and authorization
For medical devices that incorporate nanomaterials, applicants must provide comprehensive quality control documents, including physicochemical characterization of the nanomaterials used. If the nanomaterials are sourced from third-party manufacturers, the applicant should provide relevant qualification documents, contracts, and quality agreements.
Chemical and physical property studies
Applicants must conduct targeted studies to characterize the physicochemical properties of nanomaterials used in medical devices. These studies are essential for determining the suitability and performance of the nanomaterials, establishing scientific performance indicators, and developing appropriate testing methods.
Biological property studies
Physicochemical characterization is critical in assessing the biological compatibility and toxicity of medical devices using nanomaterials. It helps determine the potential risks associated with nanomaterials and their transformation products in biological tissues and fluids. Objective and reliable physicochemical characterization results are necessary for accurate risk assessments.
Cleaning, disinfection, and sterilization studies
Physicochemical characterization is also crucial in assessing the effects of manufacturing processes on the nanomaterials used in medical devices. It ensures the stability, uniformity, and integrity of the nanomaterials throughout the production process. Verification of the nanomaterials’ behavior under different sterilization methods and their distribution uniformity within the devices is also recommended.
Physicochemical characterization is important for determining the shelf-life and package validation of medical devices. For nanomaterials, specific considerations should be given to assess any physical or chemical changes during storage that may impact the device’s performance.
Related Chinese standards
In the field of nanomaterials and nanotechnology, China has nearly 200 standards, including national, industry, local, and group standards. Among these, approximately 100 standards are related to the characterization of nanomaterials and can be selectively used for the characterization of nanomaterials in medical devices. Additionally, several non-specific nanomaterial-related methods can also be applied to nanomaterial characterization in medical devices.
A table of the relevant Chinese standards applicable to nanomaterial characterization is included in the appendix of the guidelines. Contact us if you would like to learn more.
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.