Japan's Definition of Should and Shall


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Does the definitions of should and shall mean the same for Japans MHLW and PMD Act requirements for medical devices as it does in ISO 13485:2016? Where can I find these definitions? :thanx:

Ajit Basrur

Since Japan's MHLW has aligned its QMS requirements to ISO 13485:2016, I believe the definitions shall remain the same. I did a quick search on MHLW website but could not find.
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