Under the Therapeutic Goods Act 1989, an Australian Sponsor must be nominated to import, supply or export therapeutic goods in or from Australia. The Sponsor holds the ARTG entry and is legally responsible for the device in the Australian market.
Amstermed’s Brisbane office holds Sponsor entries in the ARTG and coordinates the full lifecycle: conformity assessment evidence, application, post-market monitoring and adverse event reporting.
Our Sponsor mandate is coordinated with your EU, UK and Swiss representation so a single global regulatory dossier drives all five markets.
Overseas manufacturers of medical devices intended for the Australian market.
IVD manufacturers subject to classification rules under Schedule 2A of the Therapeutic Goods (Medical Devices) Regulations 2002.
Manufacturers requiring conformity assessment evidence acceptance by the TGA (including EU CE, US FDA and MDSAP routes).
Preparation and submission of applications for inclusion in the Australian Register of Therapeutic Goods.
Acting as the single point of contact with the TGA for the manufacturer's devices.
Monitoring device performance and complaint trends within the Australian market.
Notification of adverse events, near-adverse events and recalls in accordance with TGA timelines.
Compilation and maintenance of conformity assessment evidence acceptable to the TGA.
Managing variations, cancellations and change notifications on ARTG entries.
General medical devices
In-vitro diagnostic medical devices
Active implantable devices
Software as a Medical Device
Dental devices
Ophthalmic devices
Amstermed applies the same standard process to every representation and consulting engagement, adapted to the requirements of the specific jurisdiction.
The process is designed to make regulatory obligations legible, auditable, and durable. Each stage produces documentation that becomes part of the permanent mandate record.
Written inquiry received via encrypted email or Threema. Scope and jurisdictions are outlined. A mutual non-disclosure agreement is executed.
Existing regulatory documentation is reviewed: Declaration of Conformity, certificates, quality management evidence, labelling, and technical file summary.
Amstermed regulatory reviewers assess device classification, applicable regulation, and any gaps against the requirements of the target jurisdiction.
A written mandate is drafted defining scope, term, retention obligations, termination and successor provisions, in accordance with the applicable regulation.
The mandate is executed by both parties. Amstermed formally accepts the appointment and coordinates the manufacturer's regulatory particulars.
Notification is made to the competent authority: EUDAMED, MHRA DORS, Swissmedic, TGA ARTG, or FDA registration and listing as applicable.
Full regulation in force for new devices placed on the market.
Legacy devices subject to conditional continued placement, subject to specified conditions.
All devices in scope must comply with the current framework.
Partner with Amstermed for trusted Australian Sponsor representation. Our regulatory specialists will guide you through ARTG registration, TGA communication, and ongoing compliance, helping you bring your medical devices to the Australian market with confidence.