Posted in Consultations / TGA

The Therapeutic Goods Administration (TGA) has made further refinements to the regulation of personalised medical devices with the introduction of the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021.

The Amendment:

• 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 each year without an 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 regarding their ability to meet their regulatory obligations and continue supplying personalised medical devices. 

Further consultation, both targeted and public, will be conducted by the TGA to identify additional refinements that could be made to ensure personalised medical devices are safe and fit for their intended purpose without imposing unnecessary administrative or regulatory burdens on businesses.

As you are aware the ADIA has worked closely with the Therapeutic Goods Administration (TGA) over the past 18 months on the development of the personalised medical devices framework.

On Monday the TGA announced a number of options for refining the framework that were identified as a result of the public consultations held over the last few months.

The ADIA advocated for a number of options to be considered in the development of the framework which included:

1. A review of Class 1 and Class IIa devices with a view to excluding very low risk products from Australian Register of Therapeutic Goods (ARTG) inclusion.
2. Continuing to include raw materials and components that are used to make medical  devices in the ARTG.
3. Maintaining a level playing field for all manufacturers of medical devices.
4. The ADIA suggested implementing a templated process to achieve a QMS system to reduce costs for the small laboratories and manufactures which was highlighted in a Risk Statement submitted by the ADIA in the initial consultation process.

In today's announcement the TGA have advised that: 

1. A limited number of low risk devices would be excluded from being considered to be medical devices.
2. Raw materials and components would stay on the ARTG.
3. The person assembling the low risk device would not need to include the device in the ARTG. 
4. The person assembling the device, including if they are a healthcare practitioner, will still need to meet all other regulatory requirements for medical devices.

An overview of these legislative instruments and their impact can be found on the TGA website.

What is required now?

If you manufacture or supply a product that has been included in the excluded goods determination, you do not need to register for transition or include the device in the ARTG.

If you have already registered a product that has been included in the excluded goods determination you are not required to take any further action.

Please Note:

If companies reacted to the TGA email re removing items from the ARTG before June 30 by deleting those entries, the ADIA will work with the TGA on the process for reinstating those entries.

Please reach out to the ADIA with a summary of how many ARTG entries were cancelled, and also advise on any applications rejected on the basis of the TGA position on raw materials, that will now need to be resubmitted

With the transition registration deadline of 25 August 2021 fast approaching, the TGA has produced a short video encouraging people to register their patient-matched medical devices for transition: https://youtu.be/MMGBU1-DoBg

The Therapeutic Goods Administration will provide a FREE webinar on understanding TGA regulations next Tuesday August 24.

The webinar / workshop, 'Meeting Your Obligations', is part of the TGA's SME Assist service, which is dedicated to helping small to medium enterprises (SMEs), researchers, start-ups and those unfamiliar with therapeutic goods regulation understand their regulatory and legislative obligations.

The workshop will help navigate the regulatory maze so you can clearly understand your obligations at different stages of the regulatory process.

The SME Assist 'Meeting Your Obligations' workshop via live stream from the TGA office in Canberra, next Tuesday August 24 at 1:30pm.

Topics covered include:

• Basics of regulation - an overview of therapeutic goods regulation, the role of TGA and sponsor responsibilities when supplying therapeutic goods in Australia.
   
• Case studies - general principles of market authorisation, manufacturing, advertising and post-market monitoring as they relate to therapeutic goods.
   
• Q&A with TGA staff - opportunity to ask general questions.

When: Tuesday 24 August, 2021, 1:30pm to 4:30pm

Where: online via live stream.

Click here to Register and find out more information

The Dental Board of Australia (the Board) has updated its fact sheet on using and supplying teeth whitening products for dental practitioners and this is now available on the Board's website.

The significant points of note are:

1. Only registered dental practitioners can use and supply high concentration teeth whitening products.
2. No current laws or regulations limit teeth whitening products to in-clinic use.

The fact sheet gives dental practitioners an overview of the laws and professional obligations that apply when they use teeth whitening products as part of their practice.