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TGA CA Certificate approved suppliers
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TGA CA Certificate approved suppliers
TGA CA Certificate approved suppliers
TGA CA Certificate approved suppliers
TGA CA Certificate approved suppliers
TGA CA Certificate approved suppliers
TGA CA Certificate approved suppliers
TGA CA Certificate approved suppliers
TGA CA Certificate approved suppliers
TGA CA Certificate approved suppliers
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Some Related Topic Tags
approved suppliers, class ii medical device, contract manufacturing, tga (therapeutic goods administration)
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  Post Number #1  
Old 19th June 2013, 12:05 AM
Nash27

 
 
Total Posts: 63
Please Help! TGA CA Certificate approved suppliers

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

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  Post Number #2  
Old 19th June 2013, 04:00 AM
Ronen E

 
 
Total Posts: 3,736
Re: TGA CA Certificate approved suppliers

http://www.tga.gov.au/pdf/devices-argmd-01.pdf

Go to section 6 and scroll down to "Changes to current certificates".

Cheers,
Ronen.
Attached Files: 1. Scan for viruses before opening, 2. Please report any 'bad' files by Reporting this post, 3. Use at your Own Risk.
File Type: pdf Australian regulatory guidelines for medical devices.pdf (2.51 MB, 56 views)
Thank You to Ronen E for your informative Post and/or Attachment!
  Post Number #3  
Old 19th June 2013, 06:49 PM
Nash27

 
 
Total Posts: 63
Re: TGA CA Certificate approved suppliers

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.

  Post Number #4  
Old 19th June 2013, 07:07 PM
Ronen E

 
 
Total Posts: 3,736
Re: TGA CA Certificate approved suppliers

Quote:
In Reply to Parent Post by Nash27 View Post

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.

Anytime, mate
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