Our Asia Pacific partner, Brandwood Biomedical, authored a fantastic report about last month’s China International Medical Device Regulatory Forum (CIMDR) held in Guangzhou, featuring a workshop on Biological Evaluation of Medical Devices. Twelve senior experts from ISO Technical Committee 194 attended. The workshop pertained to risk management models, importance of chemical characterization, tissue engineering, and multiple aspects of ISO 10993, including blood compatibility testing.
There are varying interpretations of ISO 10993, and different opinions on the extent of testing and specific methods used. Because of these differences, the ISO committee is working hard to establish updated standards and clarification in order to be more consistent globally. The workshop showed a strong indication of a need for changes, and efforts are being made to promote that.
China’s biological evaluation has continued to cause problems with consistency, development and growth, however the workshop displayed engagement and commitment to updating their practices. China is working hard to modernize their practices by aligning them with international standards for device regulation.
To read more about Arthur Brandwood’s opinion on the event, or for more information about the changes to ISO 10993, click here.