On June 24, the CMDE (Centre for Medical Device Evaluation) of NMPA (National Medical Products Administration) released the technical review guidelines (draft) addressing the evaluation and characterization methods for unknown leachables studies during the medical device registration process.
According to the draft guidance document, leachables are defined as the chemical substances released from the medical device and/or its materials of construction during the conditions of clinical use.
In many cases, the leachables studies are necessary to determine the safety use of medical devices in the market and avoid patients from being exposed to toxic substances.
Requirements for the evaluation report
- Device information in terms of structure and materials used for the future reference of compatibility studies
- Extraction profile including the choice of solvent, as well as the time, ratio and method of extraction used
- Qualitative analysis and results
- Quantitative analysis and results
- Conversion of the measured level of chemical substance to the level of clinical exposure
The public consultation ends on July 30, 2020.
Contact Cisema if you would like to learn more about the above news.
By Jacky Li.