Medical Device Registration in
Ministry of Health
Medical Device Regulation
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.