Japan's Definition of Should and Shall

[jiligan]

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?

 

[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.