Japan, Updated guidance on biocompatibility testing of medical devices
Updated guidance relating to biocompatibility testing of medical devices was released by The Ministry of Health, Labour and Welfare of Japan in February 2020.
With reference to the updated guidance, all biocompatibility testing must be done in accordance with the requirements provided by standard JIS T 0993-1:2020 which actually constitutes an ISO 10993-1 standard in Japanese.
This new document mainly covers the standards when confirming compliance with biocompatibility requirements for the application of approval for manufacturing or marketing medical devices.
It also details the way biocompatibility testing should be done and the particular testing methods to be applied for the results to be reliable and acceptable for its intended purposes.
Partial implementation of the requirements set forth in ISO 14971, which describes the risk management in regards to medical devices was also done in this new update.
Essential definitions such as Raw materials, The final product, Hazard and Risk were specifically highlighted.
The Japanese authorities cautioned that national and international standards could be subjected to review due to the constant development of science and technologies.
Hence, manufacturers are strongly encouraged to stay updated with the latest standards to implement the most appropriate testing method themselves.