Posted in Industry News

Refinements to the regulation of personalised medical devices

Posted by ADIA on 24 August 2021
Refinements to the regulation of personalised medical devices

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

Posted in:Consultations / TGAIndustry NewsCEO Update  

COVID-19 restrictions increased in NSW

Posted by ADIA on 23 August 2021
COVID-19 restrictions increased in NSW

The NSW Government has extended the current lockdown in Greater Sydney until the end of September and introduced new rules targeting the 12 local government areas (LGAs) of concern.

Areas of concern include: Bayside, Blacktown, Burwood, Campbelltown, Canterbury-Bankstown, Cumberland, Fairfield, Georges River, Liverpool, Parramatta, Penrith and Strathfield.
 

Additional rules for the LGAs of concern from today, Monday, 23 August, 2021.

Curfews will be introduced from 9:00 PM to 5:00 AM (except for authorised workers, emergencies, or medical care).


New restrictions around workplaces and authorised workers from the LGAs of concern will be introduced:

  • Authorised workers who work outside their LGA of concern are only permitted to work if rapid antigen testing is implemented at their work-site or they have had their first vaccination dose by 30 August.
  • From Saturday, 28 August, authorised workers from the LGAs of concern are required to carry a permit from Service NSW declaring that they are an authorised worker and cannot work from home.
  • From Saturday, 28 August, anyone entering an LGA of concern for the purposes of work must carry a worker permit issued by Service NSW.
     

Additional measure for Greater Sydney and regional NSW

From Monday, 23 August, mask wearing will be mandatory when outside your home, except when exercising for Greater Sydney (including regional NSW until 28 August).

Further information about the new measures can be found on the Business Australia website.

 

Posted in:Industry NewsCEO UpdateCovid Updates  

State by State COVID-19 business benefits

Posted by ADIA on 20 August 2021
State by State COVID-19 business benefits
Over the past 18 months Commonwealth and State governments have released a number of support packages to assist Australian businesses and individuals to remain financially viable throughout the COVID-19 pandemic. Below you will find a state by state breakdown of the available financial and support packages provided by the Commonwealth and state governments. Individuals  impacted by COVID-19 can find out more about government payments that may be available to them, including the COVID-19 Disaster Payment - a lump sum payment to help employees unable to earn income due to a COVID-19 lockdown. The Pandemic Leave Disaster Payment is available to individuals who cannot generate an income due to self-isolation orders or to care for dependents in self-isolation.   FEDERAL COVID-19 Disaster Payment
Information about the COVID-19 Disaster Payment can be found via the Prime Minister’s Media Release and on the Services Australia website.
  Backing business investment - accelerated depreciation
Eligible businesses, for the 2019-20 and 2020-21 income years, may be able to deduct the cost of new depreciating assets at an accelerated rate using the backing business investment - accelerated depreciation rules.   NEW SOUTH WALES Support for small to medium businesses (including sole traders) and small non-profits. For businesses or organisations with annual turnover of more than $75,000 for which revenue has declined by 30% or more due to the lockdown.   Support available 2021 COVID-19 Business Grants One-off grant of $7,500 to $15,000 depending on your business’ s revenue decline, which is payable for the first three weeks of the lockdown. JobSaver Payments of 40% of pre-COVID NSW weekly payroll, from $1,500 to $100,000 per week (paid fortnightly); $1,000 weekly for non-employing business. Available from 18 July 2021. Payroll tax support Provides a 25% reduction in FY22 payroll tax for eligible businesses; Payroll tax payments deferred until 7 October 2021 for all businesses; and Interest free 12-month repayment plans for deferred payroll tax. Availability is based on the full lockdown period. Support with tenancy Landlords can’t evict impacted retail or commercial tenancies without mediation. Provides land tax relief for landlords who reduce the rent for impacted tenants up to 100% of their 2021 land tax liability. These protections will last for the whole lockdown. Compare the available COVID-19 business grants and payments to determine which support best fits your business needs, here.   Support for micro-businesses (including sole traders) and small non-profits To be eligible your business or organisation must have a turnover between $30,000 and $75,000 per year, and your revenue has declined by 30% or more.   Support available 2021 COVID-19 Micro Business Grants Fortnightly grant of $1,500 From the start of the lockdown. If you are a sole trader, you are not eligible for BOTH the 2021 COVID-19 Micro Business Grant and the 2021 COVID-19 Disaster Payment. You also cannot receive both the 2021 Micro-Business Grant and the Commonwealth Disaster Payment. Support with tenancy Landlords can’t evict impacted retail or commercial tenancies without mediation. Provides land tax relief for landlords who reduce the rent for impacted tenants up to 100% of their 2021 land tax liability. These protections will last for the whole lockdown.   VICTORIA A $367 million package announced by the Commonwealth and Victorian governments on Thursday 12 August is set to provide financial assistance to many businesses in Victoria.   Support available Small Business COVID Hardship Fund To help businesses that have not qualified for existing support programs and have experienced a reduction in revenue by at least 70%. Businesses that are legally allowed to operate but have been unable to generate revenue due to restrictions. Business Costs Assistance Program Round Two The Victorian Government launched a round of grants for eligible small to medium businesses, including employing and non-employing businesses impacted by May-June 2021 restrictions in Victoria. Business Costs Assistance Program Round Two - July Extension The Business Costs Assistance Program Round Two July Extension provides eligible businesses that had not previously applied for the Program in June, or have since become eligible, with the opportunity to apply for $4800 in support. Business Costs Assistance Program Round Three - 12 August 2021 Top-Up for metropolitan Melbourne Additional payment for businesses based in metropolitan Melbourne that were recipients of the Business Costs Assistance Program Round Two or the Business Costs Assistance Program Round Two July Extension grant. Business Costs Assistance Program Round Three On Friday 6 August 2021, the Victorian Government announced an additional automatic payment for successful recipients of the Business Costs Assistance Program Round Two and the Business Costs Assistance Program Round Two July Extension. Business Continuity Fund The Business Continuity Fund supports businesses in 24 sectors that were affected by additional capacity limits when reopening in late July 2021 under COVID-19 restrictions. 21 July 2021 Top-Up Payment On Wednesday 21 July 2021, the Victorian Government announced another top-up payment for successful recipients of the Business Costs Assistance Program Round Two and the Licensed Hospitality Venue Fund 2021. 16 July 2021 Top-Up Payment The Victorian Government announced a further top-up payment for successful recipients of the Business Costs Assistance Program Round Two and the Licensed Hospitality Venue Fund 2021. Business recovery and resilience mentoring The Victorian Government and the Victorian Chamber of Commerce and Industry (VCCI) pair up to deliver a business mentoring program to help small businesses navigate the economic challenges posed by restrictions to help slow the spread of COVID-19. COVIDSafe Deep Cleaning Rebate Rebates to help businesses cover the cost of cleaning after closing a worksite due to a suspected or confirmed coronavirus (COVID?19) case. Wellbeing and Mental Health Support for Victorian Small Businesses Providing mental health support to Victorians dealing with the challenges of running a small business to help them navigate through the impacts of coronavirus (COVID-19). Circuit Breaker Business Support Package Package to assist small to medium businesses and sole traders, under the circuit breaker restrictions announced on 27 May 2021. Partners in Wellbeing helpline A confidential, one-on-one service providing support for small business owners and employees through trained wellbeing coaches, financial counsellors and business advisors.  Commercial Tenancy Relief Scheme will alleviate financial hardship faced by tenants and landlords as a result of the COVID-19 pandemic.   QUEENSLAND   Support available 2021 COVID-19 Business Support Grants for lockdown-impacted businesses in Queensland Successful applicants will receive the total value of the boosted grants ranging from $10,000 to $30,000 depending on the size of your annual payroll. Applications close 16 November 2021. 2021 COVID-19 Business Support Grants - non-employing sole traders Under the joint Queensland and Australian Government package, a $1,000 one-off grant to non-employing sole traders across Queensland has been announced. 2021 COVID-19 Business Support Grants for employing businesses Eligibility requires: a turnover of more than $75,000 per annum and an annual payroll in Queensland of less than $1.3 million; been impacted by the South East Queensland lockdown starting 31 July 2021 or the Cairns and Yarrabah lockdown starting 8 August 2021 or any other Queensland lockdown in August 2021. Coronavirus (COVID-19) business assistance finder Use this tool to discover what support is available from the Queensland and Australian governments, plus Queensland local councils. Queensland COVID-19 cleaning rebate Covers up to 80% of professional cleaning expenses, capped at $10,000 (excluding GST) per incident, where a business is identified as a COVID-19 exposure site by Queensland Health.   ACT   Support available COVID-19 Business Support Grants Deliver support of up to $10,000 for employing businesses and up to $4,000 for non-employing businesses over the three-week lockdown period where those businesses' turnover has declined by 30 per cent or more as a result of the COVID-19 health restrictions. COVID-19 Small Business Hardship Scheme - up to $10,000 Eligible small businesses will soon be able to apply to the ACT Government to receive credits for payroll tax, utility charges, rates and other selected fees and charges up to a maximum of $10,000 per operator. To be eligible for credits the applicant must be able to demonstrate 30 per cent loss in revenue. COVID-19 Disaster Payment Employees who are unable to earn an income during the lockdown may be able to access the Commonwealth Government’s COVID-19 Disaster Payment. Payment amounts will vary from $200 to up to $750 depending on the hours of work lost during the lockdown and other eligibility criteria.   SOUTH AUSTRALIA   Support available Business Support Package The Business Support Grant of $3,000 will be available to eligible small and medium businesses that suffer significant loss of income due to the lockdown, and $1,000 to eligible sole traders. The COVID-19 Disaster Payment Provides financial Support for South Australians who were unable to work due to the public health order restrictions from 21 July to 27 July 2021. SA Health mental health support Free resources are available for anyone feeling overwhelmed or needing additional support during the COVID-19 pandemic. COVID-19 Business Support Grant - July 2021 Supporti...
Posted in:Industry NewsCovid Updates  

TGA transition registration deadline of 25 August 2021

Posted by ADIA on 20 August 2021
TGA transition registration deadline of 25 August 2021

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

Posted in:Consultations / TGAIndustry News  

TGA talks - 'Meeting Your Obligations' - FREE webinar

Posted by ADIA on 18 August 2021
TGA talks - 'Meeting Your Obligations' - FREE webinar

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

Posted in:Consultations / TGAIndustry News  
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