Forms for manufacturers

These forms are for manufacturers of therapeutic goods. For a complete list of forms, see: Forms

A D G I M R T

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

D

• 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

G

• 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

I

• Inspection feedback forms
  Feedback in relation to the conduct of our inspections of manufacturers is welcomed

M

• 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