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Forms for manufacturers
These forms are for manufacturers of therapeutic goods. For a complete list of forms, see: Forms
A
- Application for conformity assessment certificates (medical devices)
Form and instructions for manufacturers to be supplied with the application for a conformity assessment certificate for medical devices
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- Declaration of conformity templates (IVDs)
Templates for manufacturers to make Declarations of Conformity for an in vitro diagnostic medical device - Declaration of conformity templates (medical devices)
Forms for manufacturers to make Declarations of Conformity for a medical device
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- GMP Clearance questionnaire
Complete this questionnaire prior to submitting your GMP clearance application and upload it as part of your evidence package on your TGA ebusiness services portal
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- Inspection feedback forms
Feedback in relation to the conduct of our inspections of manufacturers is welcomed
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- Manufacturer statutory declarations
Statutory declarations are required whenever certain situations or business operations change
R
- Request for certificates or notarised copies of TGA licences and certificates
Form for requesting: GMP Certificate of Compliance, Certified copy of GMP Certificate of Compliance, Quality Systems Certificate, Certified copy of Quality Systems Certificate, and Mutual Recognition Certificate
T
- TGA Business Services forms
Forms for sponsors, agents and manufacturers to apply for access to TGA Business Services