Things You Should Know About Medical Device Registration in Australia & New Zealand: Therapeutic Goods Act 1989 & Medicines Regulations 1984 and the Medicines Act 1981
This blog is part of a series covering general regulatory requirements and developments in Asia-Pacific and LATAM countries. In this blog, the jurisdictions of attention are Australia and New Zealand.
In Australia, the Therapeutic Goods Administration (TGA) is the authority responsible for medical device safety & quality control, and vigilance. The TGA regulates medical devices under the Therapeutic Goods Act 1989.
All medical devices are classified following a risk-based approach comparable with the European Union and the FDA classification systems. The range spans from Class I (sterile/measuring), IIa, IIb, and III, where Class I (sterile/medium) is low risk, and Class III is high risk.
All medical devices must be registered in the Australian Register of Therapeutic Goods (ARTG) database. It serves as a central repository of information for healthcare professionals, regulators, and the general public to provide a publicly accessible database of all therapeutic goods, including medical devices that are supplied in Australia.
If a company does not have a physical establishment in Australia, it is required to appoint a local authorized representative a so-called sponsor. The sponsor lodges TGA applications and acts as the mid-contact between the manufacturer and the TGA for any matters related to the product. The sponsor is the first point of contact for the TGA. The sponsor is responsible for paying product-related fees (applications, annual costs, etc.) and reporting the post-market activities to the TGA, including reporting adverse events and coordinating recalls.
Australia has recognized certain overseas regulatory approvals allowing for a faster device assessment process, decreasing overall review timelines. Products covered under the scope of a CE mark, FDA approval, and certified under MDSAP follow a faster assessment pathway than those without. Approvals from Singapore (expedited and abridged route), Malaysia, and India can also be lodged for TGA approval. This makes Australia an interesting market to enter if one of the abovementioned regulatory approvals is owned.
In addition, the TGA has a similar perspective to the FDA with respect to innovative devices and devices for emergency and compassionate use under pre-defined conditions. For example, the device must be intended to treat an unmet need, patient groups suffering a life-threatening or seriously debilitating condition, or in case of a major public health threat. The developments in Great Britain are also interesting to monitor, given that the MHRA and TGA are considering mutual recognition for approvals based on these requirements with a special focus on an innovative pathway.
If there is no overseas regulatory approval available, the full TGA conformity assessment process must be initiated, which can take up to 18-24 months, depending on the risk class of the device and the completeness of the provided documentation.
For submission with classification Class Is, Im IIa, and IIb that rely on MDSAP, CE, or US FDA, the registration will remain valid if the supporting certifications are still active and within the expiry date of the respective certification. For the TGA conformity assessment certificate, a validity of five years applies.
Did you know that you can search the TGA register for approved medical devices and IVDs?
Australian Register of Therapeutic Goods (ARTG): https://www.tga.gov.au/resources/artg
Full transparency is also given to cancellations and suspensions:
In New Zealand, the New Zealand Medicines and Medical Devices Safety Authority (Medsafe) is the authority responsible for medical device safety & quality control, and vigilance. Medsafe regulates medical devices under the Medicines Regulations 1984 and the Medicines Act 1981.
All medical devices are classified following a risk-based approach comparable with the European Union and the FDA classification systems. The range spans from Class I(basic/sterile/measuring), IIa, IIb, and III, where Class I (basic/sterile/measuring) is low risk, and Class III is high risk.
All medical devices must be listed in Medsafe’s Web-Assisted Notification of Devices (WAND) database within 30 days of commercialization. Before the device can be listed in WAND, the manufacturer must ensure that they have the documentation that proves the device’s safety and effectiveness because Medsafe may request such information.
In New Zealand, there is no requirement for an extensive review process of registration documentation, only a database registration and a declaration according to section 7 of the Medicines (Database of Medical Devices) Regulations 2003 are required to place the devices on the New Zealand market.
If a company does not have a physical establishment in New Zealand, it is required to appoint a local authorized representative a so-called sponsor. The sponsor submits WAND applications and acts as the sole liaison between the manufacturer and Medsafe for any matters related to the product. The sponsor is responsible for paying product-related fees (applications, annual costs, etc.), and similar to the Australian regulatory system, The New Zealand regulatory system requires the sponsor to be responsible for vigilance activities.
Harmonization and mutual recognition between Australia and New Zealand
Australia and New Zealand have a Trans-Tasman Mutual Recognition Arrangement (TTMRA), which means that if a medical device is legally supplied in one country, it can be recognized and sold in the other without additional regulatory processes. This harmonization streamlines market access for manufacturers targeting both markets.
However, it's important to note that the TTMRA applies to certain categories of medical devices and has specific conditions and requirements that need to be met for mutual recognition. The regulatory agencies responsible for therapeutic goods in each country (the TGA in Australia and Medsafe in New Zealand) have guidelines and processes in place to facilitate the mutual recognition of therapeutic goods under the TTMRA.
Latest regulatory developments
- TGA clarified its approach to the lapsing of conformity assessment documents due to audit delays (e.g. as a result of COVID-19, EU MDR transition, and limited EU notified body designations). You can read more about it here: https://www.tga.gov.au/how-we-regulate/manufacturing/medical-devices/conformity-assessment/conformity-assessment-bodies/tga-conformity-assessment-certification/tgas-approach-delays-medical-device-conformity-assessment-recertification.
- The TGA no longer accepts ISO 13485 certificates to support applications for new IVD devices, except if the manufacturer made a declaration of conformity under the EU IVDD before 26 May 2022. Approved IVDs supported by ISO 13485 certificates remain valid until the certificate expires.
- Manufacturers can respond to the open consultation on: Proposed application audit framework for medical devices. Manufacturers can provide feedback on key elements of a proposed application audit framework, including:
- risk factors informing non-mandatory audit selection
- criteria for mandatory audits
- the evidence to be provided with applications to inform audit selection
- limiting the number of substantial assessment rounds
- mechanisms to improve the visibility of application audit timeframes
- cost recovery measures for non-mandatory audits.
The TGA also seeks feedback about pathways for Class III devices with US FDA 510(k) approval.
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There are no specific updates for New Zealand. Medsafe continues to follow international acceptance of overseas approvals.
Australia is an interesting market for manufacturers since regulatory approvals such as CE marking, or FDA approval can be leveraged for fast-track market access. The same applies to New Zealand as the registration requirements are not as demanding as in other jurisdictions and a registration in the database is sufficient.
How can we help?
Qserve is happy to support you in compiling the required documents and registering your devices as needed. Our global registrations team will help you register your medical devices in Australia, New Zealand, and other countries. Please contact us if you need any help.
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