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New format for adverse events reporting in Japan

This article was originally published in Clinica

Executive Summary

Reporting of medical device adverse incidents in Japan looks set to become a more straightforward and relevant event now that the format of the forms is to be tailored to take into account better the specific characteristics of medical devices. The current format, similar to the pharmaceutical industry version, has been in use since 1997, reports Pharma Japan. The new format was approved at the end of March by the Council on Drugs and of Food Sanitation's medical devices safety commission. It is due to come into force this month (May).

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