Australia – Medical Device Regulations...

The Therapeutic Goods Administration (TGA)

is responsible for regulating medical devices in Australia.


The Australian regulatory guidelines for medical devices (ARGMD) describes the information to be supplied with applications to import, export, manufacture or supply medical devices in Australia. The ARGMD also describes post-market requirements for medical devices.

Before a new medical device can be supplied to the market in Australia, the TGA needs to be involved.

How Medical Devices are regulated in Australia and the key elements of the regulatory scheme >>>
The Essential Principles for Medical Device Compliance >>>
TGA definition of a Medical Device manufacturer >>>
Medical Device Risk Management >>>

The key elements of the medical device regulatory scheme include:

• product requirements (the Essential Principles) for the quality, safety, and performance of the medical device that must be complied with:

– before the device is supplied to the market in Australia, and
– on an ongoing basis while the device is supplied to the market in Australia

• a device classification scheme based on different levels of risk
• options as to how compliance with the Essential Principles can be demonstrated
• the optional use of recognised standards
• ongoing monitoring of medical devices that are available on the market
• regulatory controls for the manufacturing processes of medical devices
• the Australian Register of Therapeutic Goods (ARTG) as the central point of control for the legal supply of medical devices in Australia
• the provision for imposing penalties where regulatory requirements are breached
• a range of corrective actions that may be taken if there is a problem with a device

Life cycle approach to regulation by the Australian TGA >>>
Differences between Australian and EU Medical Device Regulation >>>
Electronic signature requirements for Medical Devices >>>
Good Manufacturing Practices for Medical Devices >>>

Legislation also makes provision for specific types of devices, including:

• single-use devices
• active medical devices (energy using)
• medical devices that contain:
– medicines
– materials of animal, microbial, or recombinant origin

• systems or procedure packs
• medical devices for export only
• custom-made medical devices

    • Medical Device Validation, Regulation, Classification, Risk Evaluation, ….
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Differences between Australian Essential Principles and European Union Essential Requirements >>>
How Medical Devices are regulated in Europe >>>
Medical Device Manufacturing Validation >>>
Medical Device Design Control >>>

Responsibilities of a medical device manufacturer
Manufacturers must:
• for each medical device, determine the:
– classification
– intended purpose
– appropriate GMDN code

• select and apply appropriate conformity assessment procedures to demonstrate compliance with the Essential Principles
• ensure that they have appropriate processes in place and documentation to demonstrate this before they apply to the TGA (or an EU Notified Body) for conformity assessment evidence
• obtain the conformity assessment evidence and ensure the information on the certificate remains current and valid
• pay the application and assessment fees for obtaining the conformity assessment evidence
• prepare an Australian Declaration of Conformity that includes all the manufacturing details for the medical devices
• ensure that their conformity assessment procedures are appropriately maintained once they obtain the necessary conformity assessment evidence, and that the ongoing requirements are met (for example, reporting adverse events, regular quality systems audits)
• notify the TGA of substantial changes to the design, production or intended performance of the device.


The Essential Principles (in detail) >>>

There are six general Essential Principles that apply to all devices. There are a further nine Essential Principles about design and construction that apply to devices on a case-by-case basis.

General principles

• Use of medical devices must not compromise health and safety
• Design and construction of medical devices to conform to safety principles
• Medical devices to be suitable for intended purpose
• Long-term safety
• Medical devices not to be adversely affected by transport or storage
• Benefits of medical devices to outweigh any side effects

Principles about design and construction. The following need to be considered…

• Chemical, physical and biological properties
• Infection and microbial contamination
• Construction and environmental properties
• Medical devices with a measuring function
• Protection against radiation
• Medical devices connected to or equipped with an energy source
• Information to be provided with medical devices.
• Clinical evidence
• Principles applying to IVD medical devices only

Medical Device regulation by the US FDA >>>
US FDA Quality System Regulations >>>
Classification of Medical Devices under the EU Directives >>>
Equipment Validation >>>


Manufacturers can demonstrate that the Essential Principles

have been met for a device in many ways. Some examples include:

• a documented and detailed risk analysis
• the results of testing of the medical device
• literature searches
• copies of the label, packaging and Instructions for Use to demonstrate that information requirements have been met

• expert opinion
• the design dossier, if applicable.

This information must be held and maintained by the manufacturer and must be made available to the TGA upon request.
The most common way to demonstrate compliance with the Essential Principles is to meet a standard published by an Australian or International Standards Agency, a Pharmacopoeia, or a similar standard.

Life Cycle approach to Process Validation >>>
CAPA Corrective and Preventative Action >>>

Standards that are commonly used by medical device manufacturers are:

• ISO 14971—Application of risk management to medical devices
• ISO 13485—Quality management systems: Requirements for regulatory purposes
• ISO 10993—Biological evaluation of medical devices
• ISO 60601—Medical electrical equipment
• ISO 10282—Single-use sterile rubber surgical gloves

Reference source –  “Therapeutic Goods Administration”.
Medical Device – Validation. Regulation. Classification. Risk. Quality Systems. … …

Changes implemented under MDD 2007 47 EC >>>
Global Medical Device Regulation >>>
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