According to the notice “Reporting Adverse Events”, some specific items when reporting adverse events are required to use the “Adverse Event Glossary” which is defined by the Japanese Ministry of Health, Labor and Welfare (MHLW).
On November 12th, MDHLW has announced in a notice, that the Japan Federation of Medical Devices Association (JFMDA) has curated the Japanese “Adverse Event Glossary” and created a mapping chart that matches with IMDRF’s Adverse Event Terminology.
The terms listed in the mapping chart is divided into two: special terms and common terms. The special terms are revised terms that were based on the Japanese “Adverse Event Glossary” and each of them is linked with the Japanese Medical Device Nomenclature. The common terms are rearranged version of the “Japanese Translation of IMDRF Adverse Event Terminology”.
The MHLW notice issued instructs to use the special terms when reported medical device has a generic name according to the JMDN. When reported medical device does not have JMDN, the notice instructs to use the common terms.
For further instruction and the mapping chart, please consult the link in the reference.
References:
MHLW Notice on February 1st, 2020 (Reporting Adverse Event)
MHLW Notice on November 20th, 2020 (Translation of IMDRF Adverse Event Terminology into Japanese)