Conformity Assessment Certificate - Australian Government

Description

You will require this certificate if you intend to manufacture certain kinds of medical devices. Once a certificate has been issued, you device may be entered onto the Australian register of medical devices.
Devices that must be approved under this certificate include:
  • devices that contain animal-originated tissue that has been made non-viable
  • devices that contain tissues, cells, microbial or recombinant substances and are intended for use in or on a human body
  • devices that incorporate (or are intended to incorporate) a substance that may be considered to assist the device
  • Class 4 in-vitro devices.

Please consult the Contact Officer for more information.

Service type

Licence

A licence defines the need to obtain recognition / certification and registration to undertake a certain business activity.

Eligibility requirements

Please consult with the Contact Officer for information on any eligibility requirements.

Fees

Fees Details for this service in table format.

Task Type Business Structure Description
Apply Application All

Please consult the Contact Officer for information on fees to be submitted.

Forms

Task Business Structure Resources
Apply All Conformity Assessment Certificate - Please consult the Contact Officer for information on forms to be submitted.

Act(s) name

Therapeutic Goods Act 1989 AG

Approval time

Maximum of 225 working days.

Administering agency

Department of Health

Therapeutic Goods Administration

Contact details

Contact Email, Phone and Address Details for this service in simple two column table format, header then data.

Enquiries

Therapeutic Goods Administration

Department of Health

Operating address: 136 Narrabundah Lane
Symonston
Australian Capital Territory 2609
Mailing address: TGA, PO Box 100
Woden
Australian Capital Territory 2606
Phone: 1800 020 653
Email: info@tga.gov.au