Ministry of Health

Australian Government, Department of Health

Regulatory Authority

Australian Therapeutic Goods Administration (TGA)

Medical Device Regulation

Therapeutic Goods (Medical Device) Regulation 2002

Australian regulatory guidelines for medical devices (ARGMD)

Official Language

English

Classification

Medical Device – Class I, Is, Im, IIa, IIb, III

IVD – Class 1, 2, 3 and 4

Registration Process

• Determine classification of the medical device.
• Appoint an Australian TGA Sponsor (for non-Australian manufacturers)
• Prepare Technical File or Design Dossier and Australian Declaration of Conformity.
• Sponsor submits Manufacturer’s Evidence (CE Mark Certificate) in TGA Business Services System.
• Sponsor submits Medical Device Application in TBS System.
• Application fee to be paid.
• TGA will review the submitted Design Dossier as part of Level 2 Application Audit
• TGA grants approval or rejection for the application
• If approval is granted, the Manufacturer can market their product in Australia.

Documents Required

• Medical Device Application
• Technical File
• Australian Declaration of Conformity
• Manufacturer’s Evidence (CE Certificate)
• Appointment of Australian Sponsor 

Post-market Requirements

If serious threat to public health – 48hrs

If leads to death or serious deterioration in health – 10 days

If might lead to death or serious deterioration in health – 30 days

Legalized/Notarised Documents (if any)

Certificates of Free Sales

Applicable QMS

ISO 13485 + Requirements for products sold sterilized

Registration Timeline

Class I & II a – 4 weeks

Class II b – 6 weeks

Class III & Active Implantable Medical Device – 6 months including application audit

Authorized Representative

Yes. Australian Sponsor

License Validity

Annual fees to be paid

Special Notes

Labelling and IFU – English

Sponsor information to be included in the labelling.