Process
Australia
Australian service process
TGA registration5 collaboration stages
- 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.
- 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.
- 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.
- 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.
- 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.
Official references
- TGA: steps to supply medical devices for Sponsors
- TGA — Understanding processing timeframes for medical device applications
Sources checked: 2026-09-11. Assess individual products and projects against current applicable requirements.
Australian Sponsor services4 collaboration stages
- 01
Product and existing arrangements
Review models, intended purpose, ARTG status, the existing Sponsor and distribution agreements to distinguish a first application, ongoing maintenance or a change of partner.
Output: product and existing-arrangement checklist.
- 02
Documentation access and responsibilities
Confirm access to manufacturer documentation, update notifications, regulatory enquiry contacts, maintenance tasks, fees and arrangements on termination.
Output: documentation access and responsibility checklist.
- 03
Application or handover coordination
Coordinate application documents within the agreed scope. Where an existing partner is involved, review agreements, entries and labels before identifying documents to transfer or update.
Output: application preparation or handover record.
- 04
Ongoing maintenance
Track document updates, product changes, complaints and adverse event information according to the applicable responsibilities, recording progress with the manufacturer and other parties.
Output: ongoing maintenance and issue tracking record.
Official references
Sources checked: 17 October 2026. Individual products and projects must be assessed against the applicable current requirements.
Market and channel services4 collaboration stages
- 01
Market and product assessment
Understand product authorization, target customers, pricing, capacity and existing channels.
Deliverable: target customers and market entry questions.
- 02
Develop a channel plan
Review purchasing settings, partner types and commercial terms to prioritise channel development.
Deliverable: channel direction and partner screening criteria.
- 03
Partner communication
Organise product information, partner screening and commercial communication within scope, recording actual feedback.
Deliverable: partnership opportunity and commercial issue tracking.
- 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.
CRO and clinical trial services4 collaboration stages
- 01
Research needs and feasibility
Discuss product stage, research purpose, evidence, protocol and site resource needs.
Deliverable: research needs and feasibility questions.
- 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.
- 03
Start-up preparation
Coordinate ethics, applicable regulatory arrangements, responsibilities and documents, and check study start-up conditions.
Deliverable: start-up documentation and responsibilities.
- 04
Execution and reporting
Coordinate agreed project management, data work and reporting, tracking progress and issues.
Deliverable: project records and agreed research outputs.
Official references
Sources checked: 2026-09-11. Assess individual products and projects against current applicable requirements.
Warehousing and logistics4 collaboration stages
- 01
Storage, transport and order requirements
Review package dimensions, storage temperature, shelf life, batch information, expected inventory and delivery areas to identify product-specific handling requirements.
Output: storage, transport and order requirements checklist.
- 02
Confirm service conditions
Check available storage resources, temperature control or other special conditions, receiving and dispatch methods, service areas and costs before agreeing the scope.
Output: confirmed service conditions and cost items.
- 03
Receiving and batch records
Check quantities, packaging and batches on receipt as agreed; establish inventory records and confirm order intake, picking and replenishment arrangements.
Output: receiving, inventory and batch records.
- 04
Delivery and exception handling
Arrange dispatch and delivery against orders and record delivery status. Define notification contacts and records for returns, damage, quantity discrepancies and traceability requests.
Output: delivery, return and exception records.
Market and marketing advice4 collaboration stages
- 01
Define the commercial question
Confirm the target country, product, customer type and decision to be made, such as selecting a channel, adjusting pricing or preparing local marketing materials.
Output: research questions and scope.
- 02
Customer and competitor research
Compile target customers, purchasing methods, competitor positioning and public evidence, distinguishing verified information from matters requiring interviews or direct contact.
Output: customer and competitor information table.
- 03
Compare pricing and channel options
Compare channel options and entry conditions against product authorisation status, purchasing requirements, pricing assumptions and supply costs, noting the limitations of each option.
Output: pricing and channel comparison.
- 04
Recommendations and open questions
Prepare recommendations addressing the original commercial question, identifying supporting evidence, unconfirmed assumptions and the information or customer feedback still needed.
Output: recommendations and a validation checklist.
Canadian service process
MDL / MDEL registration4 collaboration stages
- 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.
- 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.
- 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.
- 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.
Official references
- Health Canada: device classification and licensing
- Health Canada: MDL and MDEL distinctions and scope
Sources checked: 2026-09-15. Assess individual products and projects against current applicable requirements.
Market and channel services4 collaboration stages
- 01
Define the target market
Understand the product, authorization status, target provinces, purchasing setting and current commercial progress.
Deliverable: market scope and key questions.
- 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.
- 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.
- 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.
Clinical and evidence planning4 collaboration stages
- 01
Study objectives and existing evidence
Review the product type, study purpose, existing clinical or performance evidence, protocol version and the evidence questions to address.
Output: study requirements and evidence gaps.
- 02
Review applicable requirements
Identify Canadian regulatory and research ethics requirements for the product and study, separately recording application documents, responsible parties and matters requiring specialist confirmation.
Output: applicable requirements and open questions.
- 03
Verify local study resources
Identify study sites and specialist partners for the protocol, checking relevant experience, resources, feedback and service conditions. Keep potential resources distinct from confirmed arrangements.
Output: candidate study resources and verification status.
- 04
Responsibilities and preparation
After verifying local resources, confirm proposed parties, document responsibilities, costs and outstanding pre-study tasks. Agree any study execution separately within the confirmed scope.
Output: responsibility allocation and pre-study checklist.
Official references
Sources checked: 17 October 2026. Individual products and projects must be assessed against the applicable current requirements.
Warehousing and supply chain coordination4 collaboration stages
- 01
Review importing and distribution parties
Using the product authorisation status and supply plan, identify proposed parties for importing, distribution, inventory and after-sales responsibilities, including unresolved arrangements.
Output: proposed supply parties and responsibilities.
- 02
Document handling requirements
Record packaging, storage temperature, expiry dates, batches, expected stock, order volumes and target delivery areas, including special handling requirements.
Output: Canadian storage and transport requirements checklist.
- 03
Verify local resources
Check Canadian warehousing, delivery and related partners against the requirements, including service areas, conditions and quotations. Exclude unconfirmed resources from an executable plan.
Output: candidate partner and condition comparison.
- 04
Confirm delivery and traceability responsibilities
Once partners and conditions are confirmed, agree responsibilities for orders, stock, delivery, returns, exception notifications and batch traceability. Base the actual scope on those confirmations.
Output: supply responsibilities and delivery conditions.
Market and marketing advice4 collaboration stages
- 01
Define the commercial question
Confirm the target country, product, customer type and decision to be made, such as selecting a channel, adjusting pricing or preparing local marketing materials.
Output: research questions and scope.
- 02
Customer and competitor research
Compile target customers, purchasing methods, competitor positioning and public evidence, distinguishing verified information from matters requiring interviews or direct contact.
Output: customer and competitor information table.
- 03
Compare pricing and channel options
Compare channel options and entry conditions against product authorisation status, purchasing requirements, pricing assumptions and supply costs, noting the limitations of each option.
Output: pricing and channel comparison.
- 04
Recommendations and open questions
Prepare recommendations addressing the original commercial question, identifying supporting evidence, unconfirmed assumptions and the information or customer feedback still needed.
Output: recommendations and a validation checklist.
Preparing an Australian registration project
Documents for the first consultation How to assess existing overseas evidence
