It’s always an advantage to think outside the box. And not just beyond the borders of Europe, but quite far away – as far as Australia. The continent boasts an outstanding healthcare system and considers itself well equipped to deal with the consequences of a growing population. We want to find out more. What do Australians do differently or better than we do in Europe?
The regulatory authority
The regulatory body Therapeutic Goods Administration (TGA) is part of the Australian Department of Health and Ageing. It also acts as a conformity assessment body for Australian manufacturers and some overseas sites. In general, the Australian regulatory system is a combination of GHTF (Global Harmonisation Task Force) and European elements, using CE Marking Certificates issued by the Notified Body and enforced inspection by the TGA. The system is therefore largely based on the principles of the GHTF. Before a medical device can be marketed in Australia, an Australian Register of Therapeutic Goods (ARTG) list number must be assigned. Global Medical Device Nomenclature (GMDN) codes are required for ARTG listings. The Australian regulatory system is formally based on the European regulatory system. Medical devices, including IVD devices, are evaluated against the basic principles and in accordance with their intended use and risk-based classification. The regulatory framework for medical devices spans the life of the device and includes
The pre-market assessment: conformity assessment,
market approval: inclusion in the ARTG, and
post-market surveillance: continued compliance with all regulatory, safety, and performance requirements and standards.
For a good overview of MD and IVD regulation, see.
Australian regulatory guidelines for medical devices – Australian Regulatory Guidelines for Medical Devices (ARGMD).
The Australian regulatory guidelines for medical devices contain information on importing into, exporting from, and supplying medical devices within Australia. They also explain the regulatory requirements that apply to medical devices.
These guidelines are currently under review and will be updated soon. The latest version, including quick links with frequently requested information, can be found here:
https://www.tga.gov.au/publication/australian-regulatory-guidelines-medical-devices-argmd.
Australian Register of Therapeutic Goods – Australian Register of Therapeutic Goods (ARTG).
Therapeutic goods listed on the Australian Register of Therapeutic Goods (ARTG) can be legally supplied in Australia. Search results include consumer medicine information (CMI), product information (PI), and public summaries. The registry includes information such as product name and composition, sponsor (company) details, and manufacturer.
The ARTG list allows medical devices to be grouped as device families. This is possible based on the following characteristics:
Same sponsor
Same manufacturer
Same code within a product nomenclature system
Same classification of medical devices
Use the ARTG search here: https://tga-search.clients.funnelback.com/s/search.html?query=&collection=tga-artg.
CE Marking Certificates
In general, TGA accepts CE Marking Certificates from Notified Bodies without additional document review, but reserves the right to request documents. Class III and AIMD medical devices with CE Marking require a time-consuming Level 2 audit and design dossier review. Drug combination products and products containing animal tissue require a Certificate of Conformity Assessment (CAC) issued by the TGA.
www.tga.gov.au/form/application-conformity-assessment-certificates-medical-devices
Scope and classification
IVD medical devices are defined in the Therapeutic Goods (Medical Devices) Regulations 2002 (the MD Regulations). The classes for IVDs are classes 1, 2, 3 and 4. IVD classification is based on their intended use and the risk to public health or personal risk that may result from an incorrect result. Medical device classification is based on the European system and includes classes I, Is, Im, IIa, IIb, III and AIMD (active implantable medical device). For high-risk devices (Class III and AIMD, and most Class 4 IVD devices), there is an additional requirement: a device is assigned a Unique Product Identifier (UPI) by the manufacturer to identify the device and all variants.
For details, see https://www.tga.gov.au/sme-assist/medical-devices-regulation-introduction.
Technical documentation
Technical documentation is required to demonstrate compliance with the essential requirements of the regulations. Clinical evidence and risk management are very important for this documentation. In addition, the regulations make certain standards mandatory. As part of the pre-market assessment, it is sometimes necessary to perform a technical documentation assessment. This is performed by the TGA or by an EU Notified Body approved by the TGA.
Quality Management System
The quality management system (QMS) standard is ISO 13485; the TGA also recognizes identical standards from other jurisdictions where ISO 13485:2016 has been adopted, including Europe, Canada, and the United States. A QMS audit is required for manufacturers of all classes except Class I (non-sterile or non-measurement). The QMS audit is conducted by a notified body as part of CE certification or by the TGA. Australian manufacturers must use the TGA for Australian registration.
Foreign manufacturers must be able to designate an Australian sponsor. This sponsor performs certain regulatory functions and applies for registration in the Australian Register of Therapeutic Goods (ARTG).
European implementation of medical device and IVD regulations – implications for Australia.
Manufacturer’s Conformity Assessment Certification, issued by European Notified Bodies, is used by many sponsors of MDs and IVD devices to support their marketing authorization in Australia.
The new European Medical Device (2017/745) (EU MD Regulations) and IVD (2017/746) (EU IVD Regulations) regulations came into force in May 2017, with a transition period of three years for new medical devices and five years for IVDs.
But in April 2020, due to the COVID19 pandemic, an amendment to the EU MD regulations postponed the date when most of the provisions should have been implemented by one year, to May 26, 2021 (Regulation (EU) 2017/745 and Regulation (EU) 2020/561).
With the expiration of certification, existing medical devices and IVDs must be adapted to the new EU regulations. Australia may accept a certification that remains valid in Europe during the transition period established by the European Commission.
For details, see https://www.tga.gov.au/node/8748655
Delays in certain regulatory changes
In July 2020, the Governor General of the Council postponed the start of a series of medical device reforms that are consistent with the EU MD Regulations. To help manufacturers, they will be given an additional six months (until November 2021) after the EU MD regulations come into force in May 2021 to use certificates issued overseas.
Australian medical device regulations have been amended to delay implementation of the August 25, 2020 reforms to the following dates:
Nov. 25, 2021, for the reclassification of certain devices, including
spinal implantable medical devices,
Active implantable medical devices,
medical devices that deliver drugs or biologics by inhalation,
medical devices that are substances (or combinations of substances) for introduction into the body,
active medical devices for therapy that include a diagnostic function to significantly determine patient management; and
Medical devices intended to be used in direct contact with the heart, central circulatory system, or central nervous system.
Feb. 25, 2021, for medical device software
Feb. 25, 2021, for personalized medical devices (including 3-D printing devices); and
Nov. 25, 2021, for systems or treatment units.
Please note: Postponing the effective date of the reforms does not change the end of the transition period, which is still scheduled for October 31, 2024!
For more details, please see .
Alternative, comparable approvals from overseas regulators.
In 2018, the TGA introduced reforms with “comparable arrangements for overseas regulators” that could allow sponsors to choose alternative routes for demonstrating compliance with Australian requirements (in the event of delays in obtaining/maintaining EU conformity assessment).
These include appropriate approvals from:
US Food and Drug Administration FDA,
Health Canada,
the Ministry of Health, Labor and Welfare, and the Pharmaceuticals and Medical Devices Agency of Japan, MHLW/PMDA,
Certificates issued under the Medical Device Single Audit Program (MDSAP);
valid EC certificates issued in compliance with any of the Directives (Medical Devices, Active Implantable Medical Devices and IVDs) until their expiration date or May 2024, whichever is earliest;
the TGA conformity assessment certificate: manufacturers can apply to the TGA for a conformity assessment certificate for medical devices and IVDs.
More details can be found here.
The TGA is currently monitoring the situation. Further changes will be considered if there are significant changes to the current EU transitional arrangements provided for in the MD Regulation or the EU IVD Regulation. New information and updates will be posted on the TGA website:
Please note that all information and listings do not claim to be complete, are without guarantee and are for information purposes only.
