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ISO 9001, FDA QSR GMP Cross Reference Matrix

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duinyk

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#14
#14
Hello,

I have a US company trying to import medical devices from an OEM in china which is iso 9001 certified but not ISO 13485 which is more medical device related. My question is does my client (initial importer in US) or the OEM necessarily need to be ISO 13485 certified or do I just need to put a QMS in place which will be FDA 21 CFR compliant? And of so, does anyone have a checklist I can use to adapt the ISO 9001 quality system for FDA?

Thanks
 
Ajit Basrur

Ajit Basrur

Staff member
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#15
#15
duinyk said:
Hello,

I have a US company trying to import medical devices from an OEM in china which is iso 9001 certified but not ISO 13485 which is more medical device related. My question is does my client (initial importer in US) or the OEM necessarily need to be ISO 13485 certified or do I just need to put a QMS in place which will be FDA 21 CFR compliant? And of so, does anyone have a checklist I can use to adapt the ISO 9001 quality system for FDA?

Thanks
Click to expand...
If your question is only pertaining to US market, ISO 13485 is not a requirements and that a quality system in accordance with 21 CFR Part 820 should be in place.
 
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