TGA Expands Clinical Evidence Guidance to Address Computational Modelling and Simulation

Regulatory Update | Medical Devices & IVDs | September 2026

Australia's Therapeutic Goods Administration (TGA) has updated its clinical evidence guidance for medical devices and IVDs with a new section addressing computational modelling and simulation (CM&S).

Published on 11 September 2026, the update clarifies how manufacturers and sponsors can use in silico methods as part of a device evidence package. It's not a new standalone requirement rather, it's clearer guidance on how a developing evidence-generation method fits within the existing clinical evaluation framework.

For manufacturers building increasingly technology-driven devices, this matters: it gives computational methods greater visibility while reinforcing the TGA's core expectation credible, relevant, and clinically meaningful evidence.

What Changed?

The TGA's Clinical evidence guidelines for medical devices now include a new section: "Use of computational modelling and simulation." The guidance applies to both medical devices and IVDs, helping manufacturers collect, compile, and present clinical evidence.

Computational modelling and simulation (in silico methods) is now recognized as a potential source of supporting evidence within a clinical evaluation.

But here's the key distinction: CM&S is not, by itself, clinical evidence.

Sponsors must explain how a model's outputs connect to the device's clinical claims, intended purpose, patient population, and clinically meaningful outcomes. Modelling needs to be integrated into the broader evidence strategy not treated as a substitute for a complete clinical evaluation.

How Can CM&S Be Used?

CM&S may support your evidence package where the model is credible, fit for purpose, and clinically relevant. In certain cases, it may even supplement or partially replace traditional bench testing provided its use is clearly defined and justified.

What this doesn't mean: manufacturers can't automatically swap clinical studies for simulations. Where clinical evidence is required to demonstrate safety, performance, or benefit-risk in your intended population, that requirement doesn't go away.

The regulatory value of CM&S depends on whether you can demonstrate the model is appropriate, reliable, and relevant to the regulatory question not simply that a model was used.

What Does the TGA Expect?

A credible, fit-for-purpose model should apply a risk-informed approach to:

• Verification and validation

• Appropriate uncertainty analysis

• The relationship between model outputs and clinically meaningful outcomes

• How the model supports the overall evidence package

The level of verification, validation, and uncertainty analysis should be proportionate to how the model is used in the regulatory context. The TGA points manufacturers toward recognized frameworks like ASME V&V40 and relevant international guidance.

The bottom line: a sophisticated model isn't automatically persuasive from a regulatory standpoint. The quality, adequacy, and relevance of the supporting evidence is what matters.

Why This Matters for Manufacturers

Device development increasingly relies on advanced engineering, simulation, and digital methods. Computational approaches can help investigate device behavior, assess design questions, and generate supporting evidence without relying exclusively on physical testing for every question.

The TGA's updated guidance gives manufacturers a clearer framework for considering these methods. But it also reinforces a core principle: innovation in evidence generation doesn't remove the need for evidence quality.

Manufacturers using CM&S need to demonstrate:

• Why the modelling is appropriate for the specific question

• How reliable the model is

• What assumptions and uncertainties exist

• How outputs connect to intended purpose and clinical claims

This becomes especially relevant for innovative devices where conventional evidence approaches may not fully capture the technology's characteristics.

Who Should Pay Attention?

• Manufacturers using computational methods in device design, testing, or evaluation

• Technology-driven devices where simulation supports specific scientific/engineering questions

• Devices with complex performance characteristics where modelling aids safety or performance understanding

• Companies preparing Australian market-entry documentation

• Companies with global evidence strategies that already incorporate computational modelling

• IVD manufacturers, since the guidance explicitly covers IVDs

What Manufacturers Should Do Now

This update isn't a signal to replace conventional testing or clinical evidence with simulation. Instead, review how CM&S fits within your existing evidence strategy:

1. Identify where CM&S is being used

Map the computational models currently used across design, development, testing, and clinical evaluation.

2. Define the regulatory question

Establish exactly what the model is meant to demonstrate — and why computational evidence suits that question.

3. Assess model credibility

Document verification, validation, assumptions, limitations, and uncertainty — proportionate to the model's intended use.

4. Connect outputs to clinical evaluation

Show how modelling results relate to intended purpose, clinical claims, patient population, and meaningful outcomes.

5. Avoid treating CM&S as a standalone solution

Where clinical evidence is required, position modelling appropriately within the broader package — not as an automatic replacement.

6. Review existing documentation

Assess whether your current evidence packages adequately explain the role and reliability of computational methods.

ARQon Insight

The TGA's update reflects a broader regulatory reality: as device technology evolves, evidence-generation methods evolve with it.

For manufacturers, the opportunity isn't just using more advanced technology in testing it's ensuring new evidence methods can withstand regulatory scrutiny. Computational modelling may offer real value, but the underlying regulatory question stays the same:

Can you demonstrate, with credible and relevant evidence, that the device is safe, performs as intended, and delivers an acceptable benefit-risk profile?

This makes early regulatory planning essential consider the regulatory acceptability of your evidence-generation strategy while the product is still in development, not at the market-authorisation stage.

Key Takeaway

Australia hasn't introduced a standalone CM&S requirement. The TGA has expanded its clinical evidence guidance to explicitly address computational modelling and simulation giving manufacturers clearer direction on how in silico methods can contribute to the overall evidence package.

The message for industry: use innovation in evidence generation but support it with credible methodology, appropriate validation, and a clear connection to clinical relevance.

For manufacturers entering or expanding in Australia, this is another reason to review your clinical evidence strategy early and ensure every component of your evidence package has a clear regulatory purpose.

How ARQon Can Support You

ARQon supports medical device companies with regulatory intelligence and market-access planning across international markets, including:

• Regulatory intelligence and monitoring

• Market-entry strategy

• Regulatory gap analysis

• Clinical and technical documentation planning

• Medical device registration support

• Evidence strategy and regulatory documentation review

• Cross-border market-access planning

Stay Ahead. Stay Compliant. Stay Informed.

With ARQon Regulatory Intelligence.