Posted in Industry News

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.

Be advised of the upcoming Annual General Meeting of the Members of the Australian Dental Industry Association (ADIA). Details of this meeting are as follows:

Meeting: 2021 ADIA Annual General Meeting
Date: Monday 8 November, 2021
Time: 2:00 PM (AEDT)
Location: Online, Virtual Meeting. 

Meeting papers comprise:

1. 2021 AGM Agenda
2. 2020 AGM Minutes
3. Independent Auditor's 2021 Financial Report

NOTE: Please note that all AGM meeting papers are available in the member resources section of the ADIA website. You will need to log in to access these. Please have your password ready to log in.

At the meeting, members will have the opportunity to:

• find out about ADIA's operations and finances;
• ask questions about the operations and finances of the ADIA, and
• speak about any items on the agenda.

In addition, corporate members will be asked to vote on the resolutions proposed.

As this meeting will be held virtually, it would be helpful if any queries or questions could be addressed in advance. If you have any questions about the content of the special resolutions proposed, it would be greatly appreciated if you would raise these with the CEO prior to the day of the AGM.

At the meeting corporate members will be asked to:

• accept the minutes for the 2020 annual general meeting;
• accept the independent auditor's report.

With New South Wales achieving its stage one roadmap out of lockdown goal of 70% double vaccination rate, all local government areas within the state are no longer considered local government areas of concern and businesses began to open this week.

Victoria remains in lockdown but will also soon reach its nominated roadmap easing thresholds of 70% to 80% fully vaccinated with the caveat of "subject to health system capacity”.

What does this mean for New South Wales?

Proof of vaccination signage and guidance

From Monday 11 October 2021 all non-essential businesses must request people aged 16 and over to show proof of vaccination or a medical exemption when visiting their premises.

Business can use these guides and resources to ensure you follow the rules:

• proof of vaccination or medical exemption posters
• proof of vaccination advice for businesses
• COVID-19 vaccination guidance for your business
• COVID-19 vaccination compliance and obligations.

Registered COVID-Safe businesses can also download new QR code check-in posters updated with proof of vaccination details.

Am I responsible for ensuring only vaccinated staff, customers and visitors attend my business?

Businesses (but not businesses that are critical retail premises) are responsible for taking reasonable steps to prevent unvaccinated people entering their premises.

For example, you could:

• ensure posters outlining vaccination requirements and Service NSW QR codes are clearly visible
• train staff on ways to check proof of COVID-19 vaccination status (or a valid exemption) and what to do if someone refuses to be checked or is not vaccinated
• remind customers of vaccination requirements in marketing materials and when taking and confirming bookings
•  consider ways for non-vaccinated customers to purchase products online
• checking vaccination status upon entry where practical.

Can businesses force an unvaccinated customer to leave the premises?

There are public health orders in place that require a person to be vaccinated in certain indoor areas and public outdoor gatherings in NSW, unless an exemption applies.

If the occupier of the premises believes that a person does not have a valid exemption, the occupier can ask the person to leave the premises. If the person refuses, the occupier of the premises can notify the police.

The Australian Chamber of Commerce and Industry's (ACCI) Workplace Relations and WH&S team have prepared a comprehensive guide for employers on COVID-19 Vaccinations and the Workplace.

The Guide is a working document that will be updated with new editions and new information as legal determinations are made.

Download the guide by clicking this link.

Socially, what does this mean for me?

From today, eased restrictions will allow those who are fully vaccinated to have:

• 10-visitor limit in your home
• access to gyms, indoor recreation and sporting facilities
•  group bookings of up to 20 people in hospitality settings.
•  All premises will operate at 1 person per 4sqm indoors and 1 person per 2sqm outdoors.

The new freedoms for vaccinated people are partitioned according to single vaccination dose and second vaccination dose.

More information on the rules for NSW residents now the state has reached 70% vaccination, can be found by clicking this link.

More information on the rules for NSW residents when the state reaches 80% vaccination, can be found by clicking this link.

As part of our regular stakeholder engagement this month I met with the following associations to catch up on their activities and to discuss upcoming events, such as the Refresh Masterclass Workshop on Tuesday 9 November 2021 and ADX Sydney 17-19 March 2022.

• Nick Williams (Chair) and Mel Pitto - NZDIG (NZ Dental Industry Group - part of MTANZ)
• Bill Suen (CEO) - Dental Hygienists’ Association of Australia
• Di Woolcock (Executive Officer) - Australian Dental Prosthetists Association (ADPA)
• Kerstin Baas (CEO) & Miranda Shoppee - Australian Society of Orthodontists (ASO)
• David Hallett (CEO) - Australian Dental Association Western Australia Branch (ADAWA)
• Lisa Rusten (CEO) and Madonna McManus - Australian Dental Association Queensland Branch (ADAQ)

On behalf of ADIA I also participated in group online discussions with:

• Hon. Anthony Albanese MP
• The Hon Stuart Robert MP, Minister for Employment, Workforce, Skills, Small and Family Business
• Jeremy Ungar - Israeli Trade Association
• Mike Freelander MP (Chair) - Parliamentary Friends of Dentistry

The Exhibition and Event Association of Australia (EEAA), of which ADIA is a member, held its AGM this month. At this meeting I was appointed a Director. I attended the subsequent EEAA Board meeting.

I will continue to update you on the advocacy work ADIA undertakes on behalf of its members' interests.

Employers to receive wage subsidies

In other news, the Federal Government has pledged to pay half the wages of 100,000 apprentices for the next 12 months.

As part of a $1.2 billion commitment to upskill and reskill Australians into jobs, the Government will pay 50% of the wages of 100,000 new apprentices and trainees in their first year.

The Boosting Apprenticeship Commencements wage subsidy (BAC) is a 50% wage subsidy that is available to all Australian local business.

The BAC wage subsidy can apply to new apprentices and trainees signed up before (today) 30 September 2021.

The BAC wage subsidy is capped at $7,000 per quarter ($28,000 for the year) and is available until the 100,000 limit is reached.

“ Apprenticeships are an important pathway to get young people into jobs and to ensure there is a skills pipeline to meet the future needs of employers,” said Prime Minister Scott Morrison, announcing the package.

To be eligible for payments under the Program, your employee must be:

• an Australian citizen; or
• a foreign national with permanent residency status; or
• a New Zealand passport holder who has resided in Australia for at least six months

Other Financial Incentives

As well as the $28000 wage subsidy the State and Federal Governments provide a number of incentives to trainees and employers.