NMPA published the “Evaluation of the Safety and Effectiveness of Medical Devices Containing Nanomaterials Part I: Framework” on August 30, 2021, directing manufacturers on key issues of nanomaterials’ registration.
The concept of the nanomaterials is based on the national standard GB/T 30544.1. Nanomaterials refer to materials with any external dimension, internal or surface structure in the nanoscale, and nanoscale refers to the material between 1nm and 100 nm.
Companies active in the medical nanotechnology space include the following:
- Agilent
- Thermo Scientific
- Oxford Instruments
- Bruker
- Nanoscience Instruments
- Novascan
- Cambridge NanoTech
- Elmarco
- Heidelberg Instruments
Highlights of the Nanomaterial Device Guideline
Risk evaluation
Medical devices using nanomaterials must comply with the risk factors specified in documents including “GB/T 16886.1”, “YY/T 0316” and “Medical Device Product Benefits-Risk Assessment Registration Guideline”. The risk factors include the possibility of nanomaterials being released from the device which is the most important, exposure dose, exposure route, contact location and exposure time. Risk assessment should be carried out in stages and steps, considering exposure assessment (nanomaterial release), nanomaterial distribution and continuous retention, environmental transformation, hazard identification, and product’s benefits to the patients.
Safety evaluation
Due to factors such as the surface area, nanomaterials exhibit different physical and chemical properties. Therefore, organisms may exhibit different biological reactions from conventional materials. The applicant should design a series of tests to confirm the applicability of the test system according to the structural characteristics of the medical device, the intended use, the way of contact with the human body, the type and form of the nanomaterial contained, to establish a set of biological evaluation test. At present, the biological evaluation system of GB/T 16886 (ISO 10993) is generally applicable to nanomaterials, but specific to a medical device that uses nanomaterials, its test methods, sample preparation, cell line/animal strain selection, and endpoints of observation may be different from conventional materials.
Physical and chemical characterization
ISO/TR 13014 provides detailed information on biological evaluation parameters related to nanomaterials and methods for quantitative and/or qualitative analysis of each parameter. However, it should be noted that for a certain nanomaterial, the results obtained by using different methods for a specific property cannot be directly compared, and there is almost no unified method for physical and chemical evaluation of nanomaterials to assist in forming a reliable test plan. Applicants should choose the method of characterization on the basis of the type and form of nanomaterials in the medical device and the intended use of the medical device. The physical and chemical characterization of nanomaterials place high requirements on the R&D capabilities of medical device applicants and laboratory quality assurance systems.
The guideline also addresses the issues such as the biological evaluation of nanomaterials. For an English copy of the “Evaluation of the Safety and Effectiveness of Medical Devices Using Nanomaterials Part I: Framework”, please contact us at info@ChinaMedDevice.com.
