Author:Sonictec · Updated
Describe the change itself
Describe what exists now and what will change, listing affected products and versions. Name changes, manufacturing location changes, new models, intended uses and IFU updates may have different implications. Clear descriptions allow assessment of registration, evidence, labels, data and supply.
Different changes may require different applications
TGA's ARTG variation guidance covers changes such as manufacturer details, intended purpose and product variants, subject to applicable conditions. A Sponsor change involves separate forms and processes. Identify the type of change first rather than treating everything as a certificate update.
Source:TGA: varying ARTG entries for medical devices and IVDs
Changes in existing evidence also need communication
Record which products are affected by evidence or certificate status changes, whether alternative evidence exists, effective dates and who holds complete files. Ask the responsible party to assess Australian implications. Explain what a new certificate replaces, and discuss continued support before documents become inaccessible.
Safety information cannot wait for routine commercial meetings
TGA's post-market responsibilities guidance requires attention to product safety, quality and performance information, including faults, inadequate instructions and potentially serious consequences. Notifications and reporting must follow applicable processes and timelines. The change-management suggestions here do not replace those duties; contact your existing safety and regulatory personnel if such matters arise.
Source:TGA: medical device post-market responsibilities
Five types of handover information
Identify the product and ARTG entry, current version and proposed change, reasons and evidence, effective date and affected batches, and the assessment needed. Explain why an issue is urgent rather than simply marking it urgent. Send known facts and gaps first, then complete missing information.
Do not finalise commercial arrangements before the regulatory assessment
Before changing packaging, supply or partners, include assessment and approval dependencies in internal plans. If use of existing registration or evidence is uncertain, record open issues and owners so sales, production and regulatory teams do not promise delivery on different assumptions.
Keep records that allow an assessment to be retraced
Record who assessed the change, which documents were used, conclusions, assumptions and the version implemented. The format can be simple; the point is to retrieve the previous assessment when a product changes again.
Describe your current issue to Sonictec
Provide a change summary, product and ARTG status, Sponsor arrangements and timing. If an ongoing service agreement exists, use its communication channels first. Scope for a new engagement is confirmed separately.
Further reading
- How do TGA registration consulting and an Australian Sponsor differ?
- Why check UDI separately for a product already in the ARTG?
- What responsibilities should Chinese manufacturers clarify before choosing an Australian Sponsor?
Official references
- TGA: medical device post-market responsibilities
- TGA: varying ARTG entries for medical devices and IVDs
Sources checked: 2026-09-14. Assess individual products and projects against current applicable requirements.