Medical Device Operations Quality Management Standards

mickob21

Registered
Hi there,

Our China Agent sent us this regulation and advised we need to be compliant to it. However, my understanding is this regulation states that the "Enterprise" (meaning the China Agent) is responsible for complying with the vast majority of the Articles. Am I correct in assuming this? The reason i ask this, is I have been tasked with completing a Gap Assessment to show if our QMS complies with this regulation. However, if the vast majority of this regulation is only applicable to an "Enterprise" then I don't want to waste time and resources on this if it's not applicable.

Thanks,
Michael.
 
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