Medical Device Regulation Australia

Information & Training. | Medical Devices

Medical Device Regulation Australia – The Therapeutic Goods Administration (TGA), a Division of the Australian Government Department of Health and Ageing, is responsible for the regulation of medical devices. The Office of Devices Authorisation (ODA) is the area within the TGA responsible for the pre-market regulation of medical devices, while the Office of Product Review (OPR) is responsible for post-market regulation of all therapeutic goods.

Regulatory systems are intended to ensure a high level of protection of public health and safety. Public trust and confidence in medical devices and in the administrative systems by which they are regulated are based on the safety and performance of devices throughout their life cycle.

Validation. Classification. Regulation. Requirements. Current best practices.
FDA cGMP’s. EU MDR’s / MDD’s.
FDA Medical Device Regulation. Outline of the FDA regulatory requirements.
FDA Medical Device Classification. The FDA approach to Medical Device Classification.
EU Medical Device Regulation and Classification (per MDD’s).
^New European Medical Device Regulations (MDR’s). MDR Classification. MDR General Safety requirements.
Current Good Manufacturing Practices. QSR’s. General requirements of the QSR’s.
Quality System requirements to maintain compliant Validations.
Medical Device Process Validation. Validation requirements. Protocol development. IQ. OQ. PQ.
Medical Device Software Validation.
Medical Device Design Validation.
Electronic Signature, Electronic Records.
Life Cycle Approach to Validation.
Risk Identification. Documentation. DHR’s. DMR’s.
Etc. Etc. …
Information & Training presentation >>>

In order for the TGA to maintain public confidence in the safety, performance, benefits and risks associated with the use of medical devices on the Australian market, assessments may be conducted:

– before a device is able to be supplied to the market in Australia, and

– while a medical device is available on the market.

Before a new medical device can be supplied to the market in Australia, the TGA needs to be involved. The TGA’s regulatory requirements vary, depending on what the device is and how it is to be used. The TGA is involved in most of the stages in the life cycle of a medical device.

The risks associated with using medical devices can range from little or low potential risk to patients and users to significant potential risks.

Key elements of Medical Device Regulation Australia.

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

Medical Device Regulation Australia – The 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 Regulation Australia – The majority of medical devices must be included in the ARTG before being made available for supply in Australia. The ARTG can be accessed via the TGA website. The TGA eBusiness (eBS) services system allows users to access information about:

– Medicines

– Medical devices

– Biologicals

– Code tables and ingredients

Medical Device Regulation Australia – For a medical device to be included in the ARTG, the TGA must be satisfied that evidence exists appropriate to the perceived risks of the device to support its safe and effective use, and that an appropriate system is in place for monitoring the ongoing performance and safety of the device.

If someone intends to supply a device that is identical to a device that is already in the ARTG, even if both devices are made by the same manufacturer, an application to include the device in the ARTG must still be made to the TGA. This is because the ARTG is not only a record of the devices that can be supplied in Australia; it is also a record of all the sponsors who are legally responsible for the medical devices on the market.

The legislation requires that the TGA conduct an evaluation of the conformity assessment documentation that demonstrates compliance with the Essential Principles for:

– Australian manufacturers

– specific high-risk devices, including devices that contain:

– materials of animal, microbial or recombinant origin

– derivatives of human blood or plasma

– a medicine.

Medical Device Regulation Australia – There are other medical devices that must undergo a mandatory application audit prior to being included in the ARTG. These include:

– a medical device (other than a condom) that is indicated to be a barrier for contraception or for prevention of the transmission of disease in the course of penile penetration during sexual intercourse

– a medical device that is an implantable contraceptive device

– a medical device that is an implantable breast prosthesis containing material of fluid consistency (other than water only or a saline solution only)

– a medical device that is specifically intended by the manufacturer to be used for disinfecting another medical device

– a Class AIMD medical device

– a medical device that is a prosthetic heart valve

– a medical device that is an implantable intra ocular lens

– a medical device that is an intraocular visco-elastic fluid

– a Class III medical device that has not been assessed under the EC Mutual Recognition Agreement or the EFTA Mutual Recognition Agreement.

There are four mechanisms for accessing Unapproved Medical Devices in Australia:

– clinical trials in Australia

– authorised prescribers

– the Special Access Scheme

– personal importation

Information & Training.

Medical Device:

- - Validation. Classification. Regulation. Requirements. Current best practices.
  - FDA cGMP’s. EU MDR’s / MDD’s.
  - FDA Medical Device Regulation. Outline of the FDA regulatory requirements.
  - FDA Medical Device Classification. The FDA approach to Medical Device Classification.
  - EU Medical Device Regulation and Classification (per MDD’s).
  - ^New European Medical Device Regulations (MDR’s). MDR Classification. MDR General Safety requirements.
  - Current Good Manufacturing Practices. QSR’s. General requirements of the QSR’s.
  - Quality System requirements to maintain compliant Validations.
  - Medical Device Process Validation. Validation requirements. Protocol development. IQ. OQ. PQ.
  - Medical Device Software Validation.
  - Medical Device Design Validation.
  - Electronic Signature, Electronic Records.
  - Life Cycle Approach to Validation.
  - Risk Identification. Documentation. DHR’s. DMR’s.
  - Etc. Etc. …
  - Information & Training presentation >>>