Japan – Japanese regulatory ministry publishes guidance on biocompatibility testing to updated standard

Japan’s Ministry of Health, Labour and Welfare (MHLW) published Notification No. 0106-1 (Yakuseiki-shin-hatu #0106-1), which requires manufacturers to evaluate the biocompatibility of medical devices in accordance with JIS T 0993-1:2020. The JIS T 0993-1 standard is a translated Japanese version of ISO 10993-1 and is updated periodically to bring it in line with revisions to the parent document.  There are no differences in the technical requirements between the two standards.​

History of JIST T 0993-1 revisions and related guidance

The original edition of JIST T 0993-1 was released in 2005 based on ISO 10993-1:2003; it was revised in 2012 to align with ISO 10993-1:2007. JIS T 0993-1:2020 was issued on January 1, 2020 to align with ISO 10993-1:2018.

The MHLW previously released two guidance documents stipulating the biocompatibility data required for Pre-market Approval (PMA) and Pre-market Certification (PMC) under JIS T0993-1: Iyaku-shin-hatsu #0213001 and Yakushokuki-hatsu #0301-20…