Explore the medical device requirements currently available for Australia, organized by topic and linked to official sources.
Does the event require internal documentation, notice, prior approval, transfer, or a new application?
An ARTG variation is limited to the same kind of device.
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?
Sponsor Or Local Market Entry Owner
Australian sponsor
yes
Owns ARTG Inclusion And Market Entry Obligations
May Be Same But Each Sponsor Importer Needs Own Entry
Can Be Separate
allowed
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
Sponsor Transfer Or New ARTG
No If Valid Transfer Yes If No Transfer
New sponsor notifies TGA within 3 months; if sponsorship is not transferred the new sponsor obtains its own ARTG inclusion.
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
