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New Regulation Amendments to Personalised and Custom Medical Devices

New Regulation Amendments to Personalised and Custom Medical Devices

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The Australian Government has made amendments to the regulation of personalised medical devices, including custom-made medical devices and 3D printed devices. This follows the Therapeutic Goods Administration (TGA) consultation processes conducted in 2017 and 2019. Copies of the submissions and a summary of the feedback to the consultations are available on the TGA website.

About the regulatory changes

Minister Hunt has agreed to delay the commencement of the Therapeutic Goods Legislation Amendment (2019 Measure No 1) Regulations 2019, Schedules 1, 2 and 3 that implement changes for a number of devices to be reclassified, modernised, to clarify and improve the way custom made devices and software as a medical device are regulated. This will delay commencement from 25 August 2020 to: 

  • 25 November 2021 for reclassification of certain devices (allowing commencement to be timed for six months after the changed date for implementation of new EU Medical Device Regulations),
  • 25 February 2021 for medical device software, and
  • 25 February 2021 for personalised medical devices (including 3D printed devices). 

Amended regulations

  • Updated definitions for personalised medical devices that allow for the distinction between different design and production methodologies, depending on the level of health professional oversight;
  • Improved TGA oversight of facilities that manufacture personalised medical devices;
  • Introduction of the concept of a Medical Device Production System (MDPS) and a related framework that allows healthcare professionals to produce personalised devices for treating their patients without the need for manufacturing certification;
  • Updates to the Essential Principles to clarify what information must be supplied (to patients) with a personalised medical device; and
  • Updates to the classification rule for medical devices that record diagnostic images to capture a broader range of technologies now being used for this purpose such as 3D-printed models.

An overview of the regulatory changes is also available on TGA website.

You may wish to sign up to TGA Updates in order to be notified of new web content as it becomes available.

More detail about the definitions and transition arrangements

There are now four different definitions; custom-made medical device, patient-matched devices, adaptable medical devices, and medical device production system (MDPS). Each of these categories will have specific requirements under the regulations as outlined below.

1.Custom-made devices

The current exemption for these devices will continue to apply if the new definition of “custom-made” comes into effect. The new requirements for custom-made devices (except where the request for manufacture from a health professional was made prior to this date), includes:

  • annual reporting of custom-made devices;
  • allowing the TGA to inspect production facilities;
  • documentation about the device to be retained for certain periods; and
  • manufacturers to provide information about each custom-made medical device to the intended recipient.

2.Patient-matched devices

Under the new definition, “patient-matched medical devices” (for those custom-made devices that will be patient-matched medical devices under the new definition), a transitional exemption provision will apply. Guidance on this notification procedure will be provided soon.

3.Adaptable medical devices

The regulation of adaptable medical devices will not change.

4.Medical device production system (MDPS)

The MDPS is a new category of medical device which will allow healthcare providers to produce personalised devices for treating their patients, without the need for manufacturing certification. MDPS can include devices such as 3D printers, associated software, and resin that is intended by its manufacturer to be used by a dentist to produce dental crowns. In these cases:

  • the MDPS itself will be treated as a medical device;
  • health professionals or persons within a healthcare facility who use the MDPS (e.g., a dentist) will not be classified as a manufacturer under the Therapeutic Goods Act 1989; and
  • sponsors will be able to include MDPS on the Australian Register of Therapeutic Goods (ARTG) after 25 August 2020.  

Compliance with the new regulations

Class I custom-made and patient-matched devices, refer to only therapeutic goods meeting the updated definition of custom-made devices and will continue to remain exempt under the amendments introduced to the Therapeutic Goods (Medical Devices) Regulations 2002. Transitional arrangements have been put in place to ensure that manufacturers and suppliers of what will become ‘patient-matched’ devices can continue to supply these devices while they apply for inclusion in the Australian Register of Therapeutic Goods (ARTG).

Accessing the transitional arrangements will extend the deadline for ARTG-inclusion to 1 November 2024. The TGA are currently finalising guidance around the changes and what manufacturers and suppliers need to do from here. This is will be published soon, if you have any questions on this matter please contact ATSA or the TGA directly.

In the meantime, the Medical device inclusion process section of the Australian Regulatory Guidelines for Medical Devices (ARGMD) is a great source of information and resources relevant to including a Class I device on the ARTG.

Some of these devices will require a conformity assessment depending on the classification that the device falls in. Manufacturers may already have suitable evidence of conformity assessment certification from comparable overseas regulators that will meet regulatory requirements. This includes the EU Medical Device Directive (MDD) or EU MDR conformity assessment certificates.

Amendments to the Essential Principles in the Australian Medical Device Regulations and their implementation are also proposed to be delayed for up to two years after the commencement of European Union Medical Device Regulation changes (i.e. May 2023) and IVD Medical Device Regulations – this is still to be confirmed by the European Parliament, but is likely to be May 2022, so two years after that date.

This would provide time for industry to adjust to the EU regulations and to allow consideration of similar changes in the Australian context and ensure that the transition in Australia is implemented effectively.

Further information about the reforms will continue to be published on the TGA’s website, with the TGA also working closely with stakeholders to identify opportunities for continued consultation on guidance material over the coming months.

Several submissions to the TGA 2019 consultation highlighted the issue of how assistive technology for people with disabilities would be considered under the regulatory changes. The TGA consultation on products used for and by people with disabilities examined possible changes to the excluded goods determination on assistive technologies.  Consultation closed in late October 2019, and submissions have been reviewed. Unfortunately, this work has been impacted by the COVID-19 situation. It is currently with TGA Legal Services and will be circulated to ATSA and other stakeholders for comment prior to submission to the Government for consideration of policy approval.

If you have any questions in relation to the information provided above please contact devicereforms@health.gov.au or David.Sinclair@atsa.org.au

Alexandria EvansNew Regulation Amendments to Personalised and Custom Medical Devices
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Where to Find the Latest COVID-19 Information

Where to Find the Latest COVID-19 Information

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ATSA encourages all members to regularly visit the NDIS Commission coronavirus (COVID-19) information page, available here.

This page contains links to updates, training, alerts, and resources for NDIS participants and providers. This information is to inform and support NDIS providers to continue to deliver quality and safe supports and services to NDIS participants.

Alexandria EvansWhere to Find the Latest COVID-19 Information
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Proposed Bill to Grant NDIS Commissioner Additional Banning Powers

Proposed Bill to Grant NDIS Commissioner Additional Banning Powers

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The NDIS Amendment (Strengthening Banning Orders) Bill 2020 will soon be introduced to Parliament, with the intention of granting the NDIS Commissioner new powers. If passed, the NDIS Commissioner will have the legislative authority to prevent unsuitable people from working with NDIS participants. The details of the NDIS Amendment (Strengthening Banning Orders) Bill 2020 can be found here.

Key points if Bill is passed:

  • The NDIS Commissioner, who is responsible for regulating NDIS providers and enforcing the NDIS Code of Conduct, will be granted additional banning powers to prevent people who may pose a risk of harm to participants from entering or re-entering the NDIS
  • The NDIS Commissioner will be able to apply banning orders to people even if they are not currently working in the NDIS. This means workers who have left the NDIS, including where they have been fired due to unsuitable behaviour, can be banned from re-entering the field. The amendments also mean the NDIS Commissioner can use information from sources outside the NDIS, such as a person’s conduct in aged care or childcare work, to ban an unsuitable person from entering the NDIS in the first place.

Minister Roberts noted that Banning orders are at the extreme end of the NDIS Commissioner’s regulatory powers and are only used in the most serious of cases. The NDIS Quality and Safeguards Commission makes the details of providers and workers who have been banned publicly available in the NDIS Provider Register. People with disability, their supporters and providers can use the Register to check that the people they are engaging to deliver NDIS services have not had a banning order against them.

Alexandria EvansProposed Bill to Grant NDIS Commissioner Additional Banning Powers
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WA Government Transition to the NDIS Quality and Safeguard Commission Postponed

WA Government Transition to the NDIS Quality and Safeguard Commission Postponed

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Due to the demands created by COVID19, it has been decided that the quality and safeguarding transition from WA Government to the NDIS Quality and Safeguards Commission will be postponed till December 2020.

The transition of the oversight of quality and safeguards of the providers of supports for NDIS participants to NDIS Quality and Safeguards Commission (NDIS QSC) from the WA Government has been deferred from July 1 to December 1, 2020. This is to allow the industry and Government to focus on the demands that have been created by COVID-19 pandemic.

The current WA government oversight of service delivery to NDIS participants will continue until transition.

During the extension in time, complaints investigation and resolution area of the WA Health and Disability Services Complaints Office (HaDSCO) will be allocated more resources and the existing quality and safeguarding functions performed by the WA Department of Communities will continue.

The WA State Government has also allocated $2 million via the Sector Transition Fund to help prepare the disability sector to meet the requirements of the NDIS Commission.

It is important to note that the WA government’s current quality and safeguarding arrangements for the Continuity of Support Programme for people aged 65 and over will also be maintained by the WA Department of Communities.

Details can be found on the NDIS QSC website, if you wish to become a service provider in WA.

It is important to note that this delay only relates to the transition of regulatory oversight of NDIS support providers to the NDIS QSC i.e. registration and auditing requirements. This has no direct impact to the NDIS participants plan, funding, or the supply of AT.

Alexandria EvansWA Government Transition to the NDIS Quality and Safeguard Commission Postponed
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Updated Rules for Imported Disability Vehicles to Comply with Australian Standards

Updated Rules for Imported Disability Vehicles to Comply with Australian Standards

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Imported disability vehicles are now subject to updated rules ensuring that safety considerations are regulated to comply with Australian standards.  Changes have commenced to progressively roll out improvements as part of the new Road Vehicle Standards (RVS) legislation.

ATSA pressed the need for the application of Australian Standards for all imported disability vehicles early in 2018 through several submissions, to the Inquiry into the Road Vehicle Standards Bill 2018 and related bills. The problem was that importers of modified disability vehicles wanted an exemption to “Australian Safety Standards”, yet local vehicle builders/modifiers were required to comply with existing local standards.

ATSA’s main recommendation was:

ATSA does not believe that the intention of the legislation is to trade off safety for profit and recommends that Australian Standards are applied to all imported disability vehicles to ensure only safe product is sold into the Australian market.

After several years of hard work and representation by ATSA, new legislation has now been implemented, requiring all disability vehicles purchased in recent times, and into the future, will need to be compliant with Australian Standards. This is a great win for all who use these vehicles, recognising the need for equality under the law and ensuring that the personal safety of assistive technology users is protected as being as important as all other consumers in the broader community.

Road Vehicles Standards Australia (RVSA) Implementation: Commencement of Testing Facility Approvals provisions commenced on 6 May 2020 that implement these changes.

Details can be found in the Interim arrangements guidance document, relating to specialist and enthusiast vehicles listed page 95, 96, 97, 98, 99.

The Road Vehicle Standards (RVS) legislation is replacing the Motor Vehicle Standards Act 1989 (MVSA) as part of a phased transition over the coming months.

In order to facilitate a smooth transition to the commencement of the first phase of the RVS legislation, the Department of Infrastructure, Transport, Regional Development and Communications (“the department”) conducted a targeted prototype trial in March of the testing facilities module of ROVER (the department’s new IT system that will support applications under the RVS legislation).

Following this successful prototype trial, the Deputy Prime Minister has made the necessary legislative instrument to enable the relevant provisions of the Road Vehicle Standards (RVS) legislation to commence – this instrument is available on the Federal Register of Legislation.

We are therefore pleased to confirm that applications for testing facility approvals under the RVS legislation opened from Wednesday 6 May 2020.

The aim is for a gradual progressive rollout, with further improvements slated for introduction in the coming months. 

It is important to note that, if a test facility has prepared test reports while registered in the department’s Road Vehicle Certification System (RVCS), those reports will  continue to be used to demonstrate compliance with applicable standards provided that the test facility applies for, and is granted, a testing facility approval under the RVS legislation.

Test reports from testing facilities that have been approved under the new RVS legislation will not be required until component type approval applications open in the 3rd quarter of 2020 (anticipated commencement date).

Alexandria EvansUpdated Rules for Imported Disability Vehicles to Comply with Australian Standards
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NDIA Releases Status Tracking For Provider Enquiries

NDIA Releases Status Tracking For Provider Enquiries

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The NDIA has released a new feature to the MyPlace provider portal to assist providers in tracking the status of enquiries. The following information has been copied directly from the NDIA notice via the NATA group.

As flagged in the March and April NDIA Provider eNewsletter, the NDIA has improved the payment enquiries process for providers by introducing a ‘Payment Enquiry’ tile in the MyPlace provider portal.

By submitting a payment enquiry through the MyPlace provider portal, registered providers will receive a unique identification number to track the status of the enquiry. They will also be able to view a history of all payment enquiries made through the portal.

These features are not available when lodging payment enquiry emails via the provider.payment@ndis.gov.au inbox.

This new functionality has been implemented as a result of feedback from providers on how to enhance the payment enquiry experience.

Providers can create a payment enquiry through the MyPlace provider portal in three steps:

  • Log into the MyPlace provider portal and click the ‘View Complaints and Enquiries’ tile.
  • Click ‘Add new request’ button.
  • Click ‘Payment enquiry’ button and begin filling in the details of your enquiry.

If you or your members have questions about the use of the ‘Payment Enquiry’ tile, please call the NDIS Contact Centre on 1800 800 110.

Please note, from 29 May 2020 the NDIA will no longer accept payment enquiries to the provider.payment@ndis.gov.au email inbox. We understand this will be a change of process for some providers. 

Alexandria EvansNDIA Releases Status Tracking For Provider Enquiries
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ATSA Appoints Senior Policy Officer

ATSA Appoints Senior Policy Officer

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Anthony Pooley

ATSA is pleased to announce the appointment of Anthony (Tony) Pooley to the position of Senior Policy Officer reporting to EO, David Sinclair. Tony joined ATSA on May 1st and brings with him extensive experience in policy development and has over 20 years experience in the disability sector, including the last 5 ½ years with National Disability Services (NDS).

ATSA has a rich history in policy development and has generated dozens of submissions over the years, including undertaking research to represent our industry’s perspectives on a range of important topics.  This is core business for ATSA and has been instrumental in the building of our organisation’s influence and reputation.

With the growing demands for ATSA to be both  pro-active and responsive to the needs and interests of its membership, this appointment was viewed by the Board as essential for the ongoing strength of the organisation.

Tony joins David and Kerry Stern, Membership Officer on the ATSA team. Please welcome Tony to this new and important role.

ATSA Board

Alexandria EvansATSA Appoints Senior Policy Officer
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