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.

Impact on medical device manufacturers

Manufacturers of medical devices who are applying for either PMA or PMC may submit biocompatibility results based on JIS T 0993-1:2020 (equivalent to ISO 10993-1:2018). However, it should be noted that both PMA and PMC require testing to each endpoint listed in JIS T 0993-1:2020 Annex A.1. The testing must be conducted in compliance with Good Laboratory Practice (GLP), and compliance with ISO 17025 will not suffice.

More information about Japanese medical device regulations:

• Japan PMDA medical device registration and approval consulting
• Foreign manufacturer registration in Japan
• Japan MHLW Ordinance 169 quality system compliance
• Regulatory process chart: Japanese medical device registration