Class I Sterile Application-TGA - What application form do we need to fill in?

medwise

Involved In Discussions
#1
Hi Everyone,

We are a medical device manufacturer and are compliant with ISO 13485:2003. We are licensed to manufacture class 1 sterile and II A devices in Australia and have a conformity assessment certificate.

We want to manufacture a class I Sterile device which is a holder used in operation theaters to keep all the necessary procedural devices. Since we have already got the certificate of conformity we dont need to go through the whole process of registration. All we want to do is put up an application for this product as an existing manufacturer.

Can anyone help me to tell what application form do we need to fill in?


Any kind of help will be much appreciated.

Thank you

Kindest regards,
Romit Singh:)
 
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harry

Super Moderator
#3
Not meant to be a silly comment but since you are in Melbourne, Australia why not give them a tinkle? Their numbers are listed in their website and I am sure they welcome queries on issues not found in their FAQ.
 
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