Nash27

Involved In Discussions
#1
We would like to change our current contract manufacturer for Class IIa medical devices on our TGA conformity assessment approved supplier list. Also, we would like to add secondary supplier/contract manufacturer as part of the risk management process (2 contract manufacturers that we would like to include on CA certificate approved supplier list are audited by us and are ISO 13485: 2003 certified).

I guess, in order to do it we need to request TGA for conformity assessment certificate change notification.

1. Someone can explain me the process of changing an approved supplier on TGA CA certificate
2. How long it generally takes for TGA to amend the change ( It?s a difficult question to answer!)

Your suggestions would be much appreciated.

Thanks,

Nash
 

Nash27

Involved In Discussions
#3
Dear Ronen,

Thanks for the information. I think best way for me to do this is to lodge the change of certification through TGA eBS and take it from there. I guess, we just been through the TGA surveillance audit and should have no problem for them to update our CA certificate and add new suppliers.

:bigwave:
 

Ronen E

Just a person
Super Moderator
#4
Dear Ronen,

Thanks for the information. I think best way for me to do this is to lodge the change of certification through TGA eBS and take it from there. I guess, we just been through the TGA surveillance audit and should have no problem for them to update our CA certificate and add new suppliers.

:bigwave:
Anytime, mate :)
 

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