Explore the project process by country and service

Define registration preparation and coordination according to classification, existing evidence and the applicable pathway.

1. 01

   Product assessment

   Review intended use, composition, users, existing authorizations and Australian plans. Establish product status before identifying questions affecting classification and pathway assessment.

   Deliverable: product information review and open questions.

2. 02

   Registration strategy

   Discuss manufacturer and Sponsor roles, application sequence and documentation gaps using risk class, evidence and applicable requirements. The specific pathway depends on the product.

   Deliverable: applicable pathway, document list and stage plan.

3. 03

   Documentation preparation

   Review technical documentation, clinical/performance evidence, labels, IFU and quality system documents. Coordinate agreed gap closure and manufacturer evidence work where required.

   Deliverable: organised application documents and gap tracking.

4. 04

   Submit the application

   Once prerequisites are met, submit under the applicable pathway. Track status and coordinate regulatory questions, additional information and potential audits. TGA makes the regulatory decision; processing time varies with the application.

   Deliverable: submission records and regulatory correspondence tracking.

5. 05

   ARTG and ongoing maintenance

   After ARTG inclusion, check registration information and conditions and arrange supply, document updates, changes, complaints and adverse-event coordination. ARTG inclusion is generally needed before supply; exemptions or exceptions require separate checks.

   Deliverable: registration information checks and ongoing responsibilities.

Develop channels around target customers, partnership terms and local supply.

1. 01

   Market and product assessment

   Understand product authorization, target customers, pricing, capacity and existing channels.

   Deliverable: target customers and market entry questions.

2. 02

   Develop a channel plan

   Review purchasing settings, partner types and commercial terms to prioritise channel development.

   Deliverable: channel direction and partner screening criteria.

3. 03

   Partner communication

   Organise product information, partner screening and commercial communication within scope, recording actual feedback.

   Deliverable: partnership opportunity and commercial issue tracking.

4. 04

   Supply and ongoing coordination

   Once partnership terms are agreed, coordinate licence checks, warehousing, delivery, orders and channel feedback.

   Deliverable: responsibilities and supply coordination arrangements.

Confirm research objectives and feasibility before progressing sites, start-up preparation and execution.

1. 01

   Research needs and feasibility

   Discuss product stage, research purpose, evidence, protocol and site resource needs.

   Deliverable: research needs and feasibility questions.

2. 02

   Protocol and site coordination

   Support protocol discussions, site selection and research team communication within the agreed scope.

   Deliverable: protocol discussion records and a site collaboration plan.

3. 03

   Start-up preparation

   Coordinate ethics, applicable regulatory arrangements, responsibilities and documents, and check study start-up conditions.

   Deliverable: start-up documentation and responsibilities.

4. 04

   Execution and reporting

   Coordinate agreed project management, data work and reporting, tracking progress and issues.

   Deliverable: project records and agreed research outputs.

Assess device and establishment licensing separately, preparing documents according to applicant and activity scope.

1. 01

   Product and establishment role assessment

   Review intended use, classification, existing licences and manufacturer, importer and distributor activities.

   Deliverable: product information, establishment roles and licensing needs.

2. 02

   Licensing pathway and documentation plan

   Discuss MDL and MDEL applicability, applicant entities, document requirements and preparation sequence separately.

   Deliverable: licensing pathway and allocation of work.

3. 03

   Documentation preparation and application support

   Within the agreed scope, organise product, quality system, label and establishment procedure information for applications and responses.

   Deliverable: application documents and communication records.

4. 04

   Post-licensing coordination

   Discuss changes, updates and ongoing supply coordination according to actual licences, roles and business scope.

   Deliverable: licence information and ongoing responsibilities.

Start with target provinces and procurement settings, verifying local resources and execution scope for each project.

1. 01

   Define the target market

   Understand the product, authorization status, target provinces, purchasing setting and current commercial progress.

   Deliverable: market scope and key questions.

2. 02

   Channel and resource assessment

   Research partner types, commercial conditions and local execution needs to define the scope of resource verification.

   Deliverable: channel direction and partner assessment criteria.

3. 03

   Partnership development and commercial discussions

   Support partner identification, documentation and communication as agreed, reviewing feedback and workable conditions.

   Deliverable: partnership opportunities and conditions to confirm.

4. 04

   Implementation conditions and ongoing coordination

   Confirm actual authorizations, supply, storage, transport and after-sales arrangements together before agreeing execution scope.

   Deliverable: implementation responsibilities and next steps.