Class II and Class III Medical Device Amendment for Change in Location?

B

bblbbblb

#1
We manufacture Class II and Class III devices. Two of our devices used to be manufactured by a contract manufacturer on our behalf, however, we are now eliminating the contract manufacturer and manufacturing in-house in the same location we manufacture our other licenced devices.

All our device licences only list us as the manufacturer, there is no mention of the contract manufacturer on any licence. Do we need to submit any amendments to Health Canada for this change of bringing the manufacturing in-house?

On the same token, does anyone know if there would be any need for an FDA submission for the same change for the same devices?

Thanks!
 
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somashekar

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#2
We manufacture Class II and Class III devices. Two of our devices used to be manufactured by a contract manufacturer on our behalf, however, we are now eliminating the contract manufacturer and manufacturing in-house in the same location we manufacture our other licenced devices.

All our device licences only list us as the manufacturer, there is no mention of the contract manufacturer on any licence. Do we need to submit any amendments to Health Canada for this change of bringing the manufacturing in-house?

On the same token, does anyone know if there would be any need for an FDA submission for the same change for the same devices?

Thanks!
Your CMDCAS ISO 13485 annual survelliance audit will address this. You will map your changes accordingly in your QMS. You outsourced process control changes will be identified in the QMS.
Were you the official agent and correspondant for your CM on the FDA site in his establishment registration?
You may want to ensure that you are no more on his device listing if he is no more manufacturer for you. Feel free to discuss with FDA
 
B

bblbbblb

#3
The outsourced vendor maintains there own FDA listing, so I will just contact them and remind them to remove our device from any of their listings.

We have our CMDCAS ISO Surveillance audit coming up, so I'll be sure to discuss it with the auditor. Thanks for the advice.
 
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