TGA Conformity Assessment Support for Medical Devices and IVDs

Compliance Management Solutions prepares medical device and IVD manufacturers for conformity assessment: choosing the right procedure for the device's class, building the technical documentation and dossier, and getting the quality management system ready for audit. Conformity assessment evidence has to be in place before a device can be included in the ARTG, so it is often the longest step on the way to the Australian market.

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What conformity assessment is

The TGA describes conformity assessment as the systematic and ongoing examination of evidence and procedures to ensure that a medical device, including an IVD, complies with the Essential Principles for safety and performance. Evidence that the device has been through an appropriate procedure must be held by the manufacturer before it can be included in the ARTG.

The work falls on the manufacturer, which runs the quality management system, prepares the technical documentation and obtains the evidence. The Australian sponsor relies on that evidence to apply for ARTG inclusion, and the TGA remains responsible for the inclusion decision whoever assessed the device.

How we help

Choosing the procedure. We confirm the device's class and identify which conformity assessment procedures apply, and which evidence you already hold can be used.
Technical documentation and TGA conformity assessment dossiers. Regulator-ready technical files covering the device description and specification, intended purpose, ISO 14971 risk management, labelling and IFU, Essential Principles compliance, and post-market surveillance and vigilance planning.
Clinical and supporting evidence. Clinical evaluation support, biocompatibility gap assessments and biological evaluation reports, and usability engineering documentation.
Quality management systems. ISO 13485 implementation and readiness for certification, with independent internal audits and gap assessments before the assessor arrives.
Notified body quotations and liaison. Coordinated quotations and liaison with notified body partners, for manufacturers seeking EU certification alongside Australia.
The assessment itself. Direct communication and regulatory correspondence with the TGA, including responses to requests for information.

Our experience includes third-party certification auditing and technical file and design dossier review for notified bodies (DQS, LRQA and TÜV SÜD), so we prepare documentation the way assessors read it. We are not a conformity assessment body and do not issue certificates.

Certificate or Declaration of Conformity

A Declaration of Conformity is the manufacturer's own signed statement that the device complies with the Essential Principles and that the applicable procedures have been applied. A conformity assessment certificate is issued by an assessment body after it has examined the manufacturer. What differs by class is whether an independent assessment is needed at all.

For the lowest-risk devices, the declaration stands on its own. The procedure is described in the Regulations as a declaration of conformity "not requiring assessment by Secretary". That does not mean less paperwork: the manufacturer must still hold technical documentation, including design information, the standards applied, a risk analysis and clinical evidence.
For higher-risk devices, an assessment body examines the manufacturer's quality management system, and for Class III devices and Class 4 IVDs it also examines the design. The outcome is a conformity assessment certificate, or equivalent evidence from a comparable overseas regulator.

Which procedure each class uses

The Therapeutic Goods (Medical Devices) Regulations 2002 set the minimum procedures for each class, and the manufacturer chooses between the permitted options.

Device	Minimum procedures (manufacturer's choice where more than one)
Class I, not sterile, no measuring function	Declaration of Conformity
Class I, supplied sterile	Declaration of Conformity plus production quality assurance
Class I with a measuring function	Declaration of Conformity plus one of verification, production quality assurance or product quality assurance
Class IIa	Full quality assurance, or Declaration of Conformity plus one of verification, production quality assurance or product quality assurance. If sterile: full quality assurance, or production quality assurance plus Declaration of Conformity
Class IIb	Full quality assurance, or type examination plus one of verification, production quality assurance or product quality assurance. If sterile: full quality assurance, or type examination plus production quality assurance
Class III	Full quality assurance including design examination, or type examination plus verification or production quality assurance. If sterile: full quality assurance, or type examination plus production quality assurance
Class 1 IVD	Declaration of Conformity
Class 2 IVD	Full quality assurance, or Declaration of Conformity plus production quality assurance
Class 3 IVD	Full quality assurance, or type examination plus production quality assurance
Class 4 IVD	Full quality assurance including design examination, or type examination plus production quality assurance

A few rules sit alongside the table:

Stricter is allowed. A manufacturer of any device below Class III or Class 4 IVD may apply the procedures for a higher class.
Clinical evaluation applies on top for most devices, to show the device meets the Essential Principles on benefit and risk, performance and side effects. It is an addition to the procedures above, not an alternative.
Some devices have their own procedures. In-house IVDs, custom-made devices and system or procedure packs each follow separate procedures in the Regulations.

Getting the class right comes first, because it fixes everything that follows. See medical device classification in Australia explained.

Where the evidence can come from

A TGA conformity assessment certificate is one option, not the only one. The TGA states that from 28 July 2021, devices that contain medicines or materials of animal, microbial, recombinant or human origin, and Class 4 IVDs, no longer require mandatory TGA conformity assessment certification, and that sponsors can instead provide conformity assessment documents issued by EU notified bodies. Regulatory changes also allow Australian conformity assessment bodies to assess medical devices, alongside the TGA.

The evidence also affects the ARTG application. Under the Regulations, an application for a Class III device, a Class 3 or Class 4 IVD, a Class 4 in-house IVD, or an IVD for self-testing or point-of-care testing must be audited, unless the device holds one of the following (a small number of other exempt categories also apply), and it has not been suspended, revoked or otherwise ceased to have effect:

a TGA or Australian conformity assessment body certificate
conformity assessment documents from an EU notified body under the EU MDR or IVDR
a Health Canada licence, a US FDA premarket approval, or a pre-market certification or approval from Japan's MHLW or PMDA
an entry on the register kept by Singapore's Health Sciences Authority
certification under the UK, EC or EFTA mutual recognition agreements

For MDSAP, the TGA needs the certificates and audit reports to state that the manufacturer was assessed and found to comply with the relevant parts of the Australian regulations. What an audit involves, and how long it takes, is covered on our ARTG inclusion page.

What a TGA conformity assessment examines

Where a manufacturer applies to the TGA for a certificate, the application is made through the TGA Business Services portal, and the TGA then requests the supporting data. The assessment has three main elements.

Pre-assessment. Assessors check that the product is a medical device, that it is correctly classified, that the procedure applied suits its class, that enough information has been provided, and how many models are in scope.
Quality management system audit against the regulatory requirements and recognised standards such as ISO 13485:2016, either on site or as a desktop assessment of documents. The TGA takes MDSAP audits and audits by comparable overseas regulators, such as an EU notified body, into account, and may still audit on site if compliance cannot otherwise be determined.
Specialist assessment of the design evidence where it applies: biomaterials, engineering, software, clinical, IVD, and microbiology and sterility, each against the relevant Essential Principles. For software that uses artificial intelligence or machine learning, the TGA expects evidence that is sufficiently transparent; a "black box" approach is not acceptable.

The TGA encourages early engagement before applying, particularly for new manufacturers and novel technology. A completed Essential Principles checklist can also be provided with the application, and is a practical way to show where the evidence for each principle sits.

How long a TGA certificate takes

The TGA states that conformity assessment applications must be decided within 255 working days under regulation 4.3, not counting time the clock is stopped while the TGA waits for information. That is a legal maximum, not a typical time. The TGA also publishes non-legislated targets, which it aims to meet for 90% of applications:

Application	Target (TGA business days)	Maximum (TGA business days)
New or substantially changed certificate	160	200
Needing Advisory Committee on Medical Devices advice or an on-site audit	190	225
Recertification	80	150

These count only the TGA's own time. The time you take to answer its questions comes on top, which is why complete documentation at lodgement matters more than anything else you control.

Keeping the evidence valid

A certificate is not the end of the process. The TGA conducts surveillance audits of manufacturers holding its certificates, and substantial changes to a quality management system are normally assessed by desktop review. Under full quality assurance, the manufacturer must keep its records for at least five years after the last device is made. Where an ARTG entry relies on evidence not issued by the TGA, such as an EU notified body certificate, the sponsor must notify the TGA within 60 days of becoming aware that it has been restricted, suspended or revoked, or is no longer in effect.

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Frequently asked questions

Does every medical device need a TGA conformity assessment certificate?

No. Every device needs appropriate conformity assessment evidence before it can be included in the ARTG, but for most devices that evidence does not have to be a TGA-issued certificate. Class I devices that are not sterile and have no measuring function, and Class 1 IVDs, rely on the manufacturer's Declaration of Conformity. Higher-class devices can generally rely on evidence from an EU notified body or another comparable overseas regulator instead of a TGA certificate.

What is the difference between a conformity assessment certificate and a Declaration of Conformity?

A conformity assessment certificate is issued after an assessment body, such as the TGA, has examined the manufacturer's quality management system, or a representative sample of the device, and, for the highest-risk devices, the design. A Declaration of Conformity is the manufacturer's own signed statement that the device complies with the Essential Principles and that the applicable procedures have been applied. For the lowest-risk devices the declaration is not assessed by the TGA before use, but the manufacturer must still hold full technical documentation behind it.

Can we use our EU MDR or IVDR certificate in Australia?

Yes. Since 28 July 2021, sponsors can provide conformity assessment documents issued by EU notified bodies to support an ARTG application. The documents must be for the same device, and they must not have been suspended or revoked.

How long does a TGA conformity assessment take?

The TGA states that conformity assessment applications must be decided within 255 working days under regulation 4.3, not counting time the clock is stopped while the TGA waits for information. The TGA's non-legislated targets are 160 TGA business days for a new or substantially changed certificate, 190 where advice from the Advisory Committee on Medical Devices or an on-site audit is needed, and 80 for recertification. It aims to meet those targets for 90% of applications.

Can a manufacturer choose a stricter procedure than its class requires?

Yes. The Regulations set the minimum procedures for each class, and allow a manufacturer to apply the procedures for a higher class if it prefers. That can make sense where one quality system has to cover a range of devices in different classes.

Is Compliance Management Solutions a conformity assessment body?

No. We do not issue conformity assessment certificates. We prepare manufacturers for assessment: the technical documentation, the quality management system, the dossier and the correspondence, so that the TGA or notified body has what it needs to reach a decision.