It is always an advantage to look beyond your own nose. And not only beyond the borders of Europe, but far away - as far as Australia. The continent prides itself on its excellent healthcare system and considers itself well equipped to deal with the consequences of a growing population. We want to know more about it. What do Australians do differently or better than we do in Europe?
The regulatory body
The regulatory authority is the Therapeutic Goods Administration (TGA), it is part of the Australian Government Department for Health and Ageing. The TGA is also the conformity assessment body for Australian manufacturers and some foreign sites. In general, the Australian regulatory system is a combination of GHTF (Global Harmonisation Task Force) and European elements by leveraging Notified Body issued CE marking certificates and the enforced control by TGA. The system is therefore largely based on the GHTF principles. Before a medical device can be marketed in Australia, an Australian Register of Therapeutic Goods (ARTG) listing number needs to be assigned. The Global Medical Device Nomenclature (GMDN) Codes are required with the ARTG listings.
The Australian regulatory system is formally based on the European regulatory system. Medical devices including IVD devices are assessed against the Essential Principles and in line with their intended purpose and risk-based classification. The regulatory framework for medical devices spans the life of the device and includes:
- Pre-market assessment: conformity assessment
- Market authorisation: inclusion in the ARTG
- Post-market monitoring: continuing compliance with all regulatory, safety and performance requirements and standards.
For a good overview of MD and IVD regulation, visit https://www.tga.gov.au/sme-assist/medical-devices-regulation-introduction
Australian regulatory guidelines for medical devices (ARGMD)
The Australian regulatory guidelines for medical devices provides information on the import into, export from and supply of medical devices within Australia. It also explains the legislative requirements that govern 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:
Australian Register of Therapeutic Goods (ARTG)
Therapeutic goods entered in the Australian Register of Therapeutic Goods (ARTG) can be lawfully supplied in Australia. Search results include Consumer Medicines Information (CMI), Product Information (PI) and Public Summary documents. The Register holds information such as product name and formulation details, sponsor (Company) and manufacturer details.
The ARTG listing allows grouping of medical devices as device families. This is possible along the following features:
- Same sponsor
- Same manufacturer
- Same device nomenclature system code
- Same medical device classification
Use ARTG search here: https://tga-search.clients.funnelback.com/s/search.html?query=&collection=tga-artg
CE marking certificates
In general, the TGA accepts CE marking certificates from Notified Bodies without additional document review, but reserves the right to request documents. Medical devices of class III and AIMD with CE marking require a time-consuming Level 2 Audit and review of the design dossier. Drug combination products and incorporate animal tissue require a TGA issued Conformity Assessment Certificate (CAC).
Scope and classification
IVD medical devices are defined in the Therapeutic Goods (Medical Devices) Regulations 2002 (the MD Regulations). Classes for IVDs are Class 1, 2, 3 and 4. IVD classification is based on their intended purpose and the public health risk or personal risk that may arise from an incorrect result. Medical Device classification is based on the European system and includes the classes I, Is, Im, IIa, IIb, III and AIMD (active implantable Medical Device). There is also a further requirement for high risk devices (class III and AIMD, and most class 4 IVD devices): a unique product identifier (UPI) is assigned to a device by its manufacturer to identify the device and any variants.
For details, please see https://www.tga.gov.au/sme-assist/medical-devices-regulation-introduction
The technical documentation is required to show compliance to the Essential Principles of the regulations. Clinical evidence and risk management are very important to this documentation. Also, the regulations make certain standards mandatory. As part of the premarket assessment it is sometimes required to perform an assessment of the technical documentation. This is performed by the TGA or by an EU Notified Body approved by the TGA.
The standard for quality management systems (QMS) is the ISO 13485, and TGA will also recognize identical standards in jurisdictions where ISO 13485:2016 has been adopted, including Europe, Canada, and the US. A QMS audit is required for manufacturers of all classes except for class I (not sterile or without a measuring function). The QMS audit is carried out by a Notified Body as part of the CE mark certification, or by the TGA. Australian manufacturers must use the TGA for Australian registration.
Foreign manufacturers must have an Australian sponsor. The sponsor assumes certain regulatory responsibilities and applies for registration on 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 for supporting their marketing authorisation in Australia.
The new European regulations on medical devices (2017/745) (EU MD Regulations) and IVDs (2017/746) (EU IVD Regulations) went into force May 2017, with a transition period of three years for new medical devices and five years for IVDs.
But in April 2020, in the light of the COVID19 Pandemic, an amendment to the EU MD Regulations postponed the date that most provisions were set to commence by one year to 26 May 2021 (Regulation (EU) 2017/745 and Regulation (EU) 2020/561).
With certification expiry, existing medical devices and IVDs need to change to the new EU regulations. Australia may accept certification which remains valid in Europe during the transitional period outlined by the European commission.
For details, please see https://www.tga.gov.au/node/8748655
Delays to certain regulatory changes
In July 2020, the Governor-General in Council postponed the onset of a number of medical device reforms aligned with EU MD Regulations. To help manufacturers, they are given additional six months after initiation of the EU MD Regulations in May 2021 (until November 2021), to leverage certificates granted overseas.
The Australian medical device regulations have been amended to delay the implementation of reforms from 25 August 2020 to the dates following:
- 25 November 2021 for reclassification of certain devices, including
- spinal implantable medical devices
- active implantable medical devices
- medical devices that administer medicines or biologicals 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 that are intended to be used in direct contact with the heart, the central circulatory system or the central nervous system
- 25 February 2021 for medical device software
- 25 February 2021 for personalised medical devices (including 3D printed devices) and
- 25 November 2021 for systems or procedure packs.
Please note: the delay to the effective date of the reforms does not change the end of the transition period, which still is 31 October 2024!
For further details, please see https://www.tga.gov.au/delays-commencement-certain-medical-device-regulatory-changes
Alternative comparable overseas regulatory approvals
In 2018, TGA implemented a reform with “comparable overseas regulator arrangements”, which may allow sponsors to choose alternative pathways for demonstrating compliance with Australian requirements (in case of delays in obtaining/maintaining EU conformity assessment).
These include appropriate approvals from:
- the US Food and Drug Administration FDA
- Health Canada
- The Ministry of Health, Labour and Welfare and Pharmaceutical and Medical Devices Agency of Japan, MHLW/PMDA
- Certificates issued under the Medical Device Single Audit Program (MDSAP).
- Valid EC Certificates issued in accordance with any of the Directives (medical devices, Active Implantable Medical Devices and IVDs) until their expiry date or May 2024, whichever is the earliest
- TGA Conformity assessment certificate: Manufacturers may seek conformity assessment certificate for medical device and IVD from the TGA.
For more details, please see https://www.tga.gov.au/european-implementation-medical-device-and-ivd-regulations-implications-australia
The TGA is currently monitoring the situation. Further amendments will be considered if there are any further significant changes to the current EU transitional arrangements given in the EU MD Regulation or EU IVD Regulation. New Information and Updates will be published on TGA´s website: https://www.tga.gov.au/medical-devices-ivds
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