Author:Sonictec · Updated
One total price may cover different work
Two quotes for the same product may cover only submission coordination, or also document review, ongoing Sponsor support and third-party costs. Compare product scope, deliverables and pricing assumptions before judging price. Existing CE status or a product name does not establish that no further evidence assessment is needed.
Service fees: ask for defined deliverables and scope
Service fees may cover pathway assessment, document review, gap analysis, document coordination and submission communication. Specify models or product scope, handling of supplementary requests and approval of extra work. Distinguish an initial planning budget from a formal quote based on clear product and documentation boundaries.
Official fees: distinguish them from consulting fees
TGA official fees may cover applications and applicable assessment or audit work; annual charges are a separate category. Check current TGA fee information and rules for applicable items and amounts. Ask whether a quote includes official fees, who pays them, which schedule was used and how changes will be handled. This article links to official information rather than assigning one price to every medical device.
Source:TGA: current application fees and annual charges
Ongoing costs: official annual charges versus Sponsor services
TGA annual charges and a provider's ongoing Sponsor service fees are different. The former follow applicable official rules; the latter should specify work covered, billing periods and termination terms. Official exemptions also require separate assessment. An exemption for one product in one year does not establish a permanent exemption.
Source:TGA: current application fees and annual charges
Third-party work: confirm whether it is necessary
Existing evidence and product requirements may lead to additional testing, translation, quality system or specialist work. Distinguish identified necessities from contingencies. Ask whether third-party fees are collected on your behalf, require separate engagement and need approval before expenditure.
Timeline estimates also need assumptions
If manufacturer documentation is incomplete, the overall timeline cannot be based solely on provider processing time. A quote's stage plan should state prerequisites, manufacturer inputs and possible adjustments for regulatory questions. Aligning payments with work or deliverables supports project management.
Six questions for comparing candidates
Which products and tasks does this quote cover or exclude? How are official and ongoing costs presented? How are supplementary requests charged? Who approves third-party costs? What happens on termination or a scope change? These are procurement discussion prompts; actual terms must be agreed by both parties.
Ask for a quote with a verifiable basis
Ask the quoting provider to specify products and stages covered, official fee sources and assumptions, and separately explain additional information, scope changes and exit arrangements. Recheck actual charges when official fees change rather than relying on old articles. This article introduces no unconfirmed Sonictec prices or promotional starting prices.
Separate confirmed budget items from costs awaiting assessment
For example, distinguish an agreed stage-one document review from testing whose necessity is still uncertain. This budgeting approach clarifies which costs cover defined work and which depend on further assessment. Do not include unsupported savings percentages in decision materials.
Providing quote information to Sonictec
Describe intended use, models, certificates and technical file readiness, ARTG/Sponsor status and support sought. We can then define work and a quotable scope. Channels, warehousing and registration can be discussed separately rather than bundling unverified tasks into one package.
Further reading
- Choosing a TGA service provider: scope, fees and ongoing responsibilities
- How do TGA registration consulting and an Australian Sponsor differ?
- What should you prepare before a TGA registration consultation?
Official references
- TGA: current application fees and annual charges
- TGA: using assessments from comparable overseas regulators
- TGA: medical device post-market responsibilities
Sources checked: 2026-09-14. Assess individual products and projects against current applicable requirements.