Medical Device Registration in
Ministry of Health
Australian Government, Department of Health
Australian Therapeutic Goods Administration (TGA)
Medical Device Regulation
Therapeutic Goods (Medical Device) Regulation 2002
Australian regulatory guidelines for medical devices (ARGMD)
Medical Device – Class I, Is, Im, IIa, IIb, III
IVD – Class 1, 2, 3 and 4
- 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.
- Medical Device Application
- Technical File
- Australian Declaration of Conformity
- Manufacturer’s Evidence (CE Certificate)
- Appointment of Australian Sponsor
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
ISO 13485 + Requirements for products sold sterilized
Class I & II a – 4 weeks
Class II b – 6 weeks
Class III & Active Implantable Medical Device – 6 months including application audit
Yes. Australian Sponsor
Annual fees to be paid
Labelling and IFU – English
Sponsor information to be included in the labelling.