Japan Revises Electrical Safety Standard for Medical Devices

The Japanese Ministry of Health, Labour and Welfare has set a May 2017 compliance date for a revised version of the Japanese Industrial Standard for medical device electrical safety.

The new version, JIS T 0601-1:2012 (IEC 60601-1:2005 modified), replaces JIS T 0601-1:2009 (IEC 60601-1:1998+A1:1993+A2:1995 identical).

For new medical device registration applications submitted to the Pharmaceutical and Medical Devices Agency (PMDA), registrants may add a declaration of compliance with the new electrical safety standard provided their devices were examined in testing labs that conform to the new standard.

For medical devices that already have PMDA approval for sale in Japan, there are two ways to come into compliance with JIS T 0601-1:2012. First, manufacturers of devices that do not require design or structural changes in order to achieve JIS T 0601-1:2012 compliance may amend their registrations the next time they need to submit partial change applications or minor change submissions.

Manufacturers whose devices must undergo design or structural changes for JIS T 0601-1:2012 compliance will need to submit partial change applications to the PMDA.

Stewart Eisenhart

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