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, your 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.

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 Amount Description
Apply Application All $1077.00

Fees for 2022-23

Apply Application All $10568.00

Priority applicant. Fees for 2022-23

Apply Application All - Other fees may apply depending on your circumstances. Details can be found in the attached fee resource.

Forms

Act(s) name

Therapeutic Goods Act 1989 Australian Government

Regulation(s) name

Therapeutic Goods (Medical Devices) Regulations 2002 Australian Government

Approval time

Maximum of 225 working days

Administering agency

Department of Health and Aged Care

Therapeutic Goods Administration

Contact details

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