Therapeutic Goods Administration
The Therapeutic Goods Administration (TGA) has made regulatory changes to the way they will govern the production or customisation of medical devices. These changes will pertain to Occupational Therapists who make any devices that are “intended to diagnose, prevent, monitor, treat or alleviate a disease or injury."
Following consultation, further refinements have been made to the regulation of personalised medical devices with the introduction of the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021.
- Extends the deadline for stakeholders to register a patient-matched medical device for transition to inclusion in the Australian Register of Therapeutic Goods by 12 months to 25 August 2022.
- Introduces an exemption for patient-matched medical devices that are supplied in very low volumes, allowing the supply of up to five (5) devices a year without inclusion in the ARTG.
The following web pages and guidance documents have been updated to reflect these refinements:
- The personalised medical devices landing page.
- Personalised medical devices (including 3D-printed devices).
- Custom-made medical devices landing page.
These refinements seek to address stakeholder concerns over their ability to meet their regulatory obligations and continue supplying personalised medical devices. Further consultation, both targeted and public, will be conducted by TGA to identify further refinements that could be made to ensure personalised medical devices are safe and fit for their intended purpose without imposing unnecessary administrative or regulatory burden. More information about these activities will be made available as work progresses.
TGA has produced a short video encouraging people to register their patient-matched medical devices for transition.
August 2021: Member alert – you must apply for medical device transition by 25 August 2021
The Therapeutic Goods Administration (TGA) currently regulates therapeutic products, including personalised medical devices. Devices relevant to allied health include hand splints, orthoses and prostheses, cervical spine collars, moulds used to anchor hearing aids, and compression garments.
A new Framework for regulating personalised medical devices came into force in February 2021. Most of the devices used in allied health are now called ‘patient-matched’ devices and are classified as ‘Class 1’. The big change from previously is that those devices must now be registered with the TGA.
This has raised concerns and uncertainties for healthcare professionals, and the TGA is now reconsidering some of the ways that personalised medical devices should be regulated.
Regardless of what changes end up being made, it is important that members know that for now, the Framework continues to apply to devices manufactured by allied health professionals. The TGA has allowed for the transition to registration by requiring a Transition Notification Form to be submitted for each device, by 25 August 2021. (The actual registration, which is more labour-intensive, is not due until 1 November 2024.)
An example of a Transition Notification Form (TNF) can be found here.
It is very important to submit a TNF if you are required to do so, because otherwise you will not be able to use the device after 25 August.
June 2021: TGA Consultation: Refinements to regulatory changes
OTA is pleased to advise that TGA has made refinements to their proposed regulatory changes in response to feedback provided across the sector. In summary, they have proposed the following principles that should reduce unnecessary regulatory burden for occupational therapists and other Allied Health providers:
- Reduction or removal of unnecessary regulatory burden by:
- not regulating products where there is no risk to safety (a no-harm principle); or
- not regulating twice (that is, where suitable frameworks for product or system oversight are already in place).
- Applying an appropriate level of oversight that is commensurate with the risk of the device.
- Ensuring the Australian regulatory requirements for medical devices are met, thereby ensuring devices are safe and fit for their intended purpose.
The regulatory refinement also includes TGAs proposed view that:
- Where a medical device has been “prescribed” by a registered health professional and is manufactured by a qualified or accredited professional according to the specifications provided by the healthcare practitioner, risks can be adequately mitigated (e.g. Class I (low-risk) patient-matched medical devices could be exempted where they are being manufactured by a health professional registered with the Australian Health Practitioner Regulation Agency (AHPRA) under the Health Practitioner Regulation National Law Act 2009, and whose scope of practice encompasses the production of the patient-matched medical devices that they are producing).
- The devices produced are intended to be used by a patient of the healthcare facility, registered provider or AHPRA-registered health professional.
Further details of these refinements are available in the “Consultation: Proposed refinements to the regulation of personalised medical devices. OTA will be submitting a response to the TGA based on member feedback and we invite you to make independent submissions to TGA through their Consultation Hub. All submissions are due by 14 July 2021.
May 2021: TGA Webinar and FAQs
OTA is pleased to share with you the transcript of the TGA webinar and Q&A held on 10 May 2021. This interactive webinar was presented by TGA at the request of OTA, AHTA and APA to further clarify how the regulatory changes may affect allied health clinicians and to provide a platform for members to discuss issues of concern. This transcript includes answers to all the questions raised during the webinar that you may find useful to refer to.
April 2021: TGA Update: Information Webinar
In recent weeks, the OTA, AHTA and APA have collaborated with the TGA on a webinar presentation that will assist members to learn about the regulatory changes from TGA. The webinar will include:
- The background around the regulatory environment for medical devices
- An overview of the changes
- Specific examples demonstrating the impact of the new framework
- Information about the deadlines and transition periods for impacted devices
- Next steps for impacted stakeholders.
The webinar will be held on Monday 10 May 2021 at 7.00 pm – 8.00 pm AEST
Register for the webinar to find out more about how these regulatory changes may affect you.
March 2021: TGA Update: Is my product a medical device?
OTA is aware that there are many concerns about how the TGA regulatory changes will affect occupational therapy practice. We are discussing your concerns directly with TGA who will provide more detailed information soon. We will provide further information when it comes to hand.
In the meantime, we encourage you to familiarise yourself with the TGA Regulatory Changes and make use of the TGA interactive decision-making tool to help you determine if your product is a medical device and if it should be included in the Australia Register of Therapeutic Goods (ARTG).
February 2021: TGA Regulatory Changes
Many of you will be aware that the Therapeutic Goods Administration (TGA) is planning to change regulatory arrangements for those clinicians who manufacture items of assistive technology or who adapt pre-fabricated devices beyond their design envelope.
We are pleased to advise that TGA have extended the date of implementation so more consultation can take place. They will not take effect from 25 February 2021 as first proposed.
We recommend you review the proposed regulatory changes in the overview of the TGA Framework on the TGA website.
We will be consulting with the TGA about the scope of their proposed changes and how they may (or may not) affect you.
We will keep you informed of developments.