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
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
