Along with the Prime Minister's announcements for the general public and business on Friday, the Australian Health Protection Principal Committee, led by Professor Brendan Murphy also announced a roll back to level one restrictions for dental practitioners. This reflects an easing of restrictions on elective surgery, investigations and procedures.

The move was made in light of the current epidemiology and the wider availability of surgical masks and other personal protective equipment. The lighter restriction level will apply to all dental practitioners.

Essentially, this means as long as a patient is deemed not at risk of having or transmitting COVID-19, they can be treated following the usual safety protocols.

Both the AHPPC and the Australian Dental Board outlined this change can only be taken in consultation with any State-based regulations. Where the State regulations are tougher, they will take precedent. The Australian Dental Board will be advising all dental practitioners today.

The Australian Dental Association released a decision tree for level one restrictions on Friday.

We will continue to monitor any changes to the dental industry, along with any news relevant to wider business.

ENDS.

Currency Of Information & Disclaimer

This update was issued on 11 May 2020 and please note that changes in circumstances after the publication of material or information may impact upon its accuracy and also change regulatory compliance obligations. The statements, regulatory and technical information contained herein are believed to be accurate and are provided for information purposes only. Readers are responsible for assessing its relevance and verifying the accuracy of the content. To the fullest extent permitted by law, ADIA will not be liable for any loss, damage, cost or expense incurred in relation to or arising as a result of relying on the information presented here. 

Invitation to comment: Sterilisation and Substantial changes

The Therapeutic Goods Administration (TGA) is requesting your comments on the following documents regarding Sterilisation and Substantial changes.

Click here to read the Changes affecting TGA issued conformity assessment certificates documentation.

Background
The TGA guidance 'Checklist guidance to supporting data required for adding or changing sterilisation suppliers for TGA conformity assessment applications' provides additional detail on the documentation required for applications relating to sterilisation supplier changes. It is acknowledged that incomplete or inadequately prepared submissions can further lengthen TGA's review process.

Click here for the Guidance checklist for substantial changes to Sterilisation suppliers.

We look forward to your thoughts. Please submit your response to policy@adia.org.au by close of business Monday, 11 May 2020. Feedback will then be compiled and submitted on Wednesday, 13 May 2020.

Invitation to comment: Scope of regulated software-based products

The Therapeutic Goods Administration (TGA) is requesting your comment on a consultation on a potential exemption or exclusion of certain regulated software-based products (Software as a Medical DeviceSaMD).

Medical device regulations are currently being reformed, including SaMDsuch as smartphone apps that may be used to diagnose and monitor disease. The reforms are also in line with similar changes introduced by regulators internationally, including in the EU.

Background Information
In 2019, the TGA consulted with stakeholders on a proposal to amend the existing regulations in relation to SaMD. Following this consultation, on 12 December 2019, the Therapeutic Goods (Medical Devices) Regulations 2002 were amended to (in part):

a) provide further detail in the essential principles for SaMD including with regard to cyber security; the management of data and information; and requirements relating to development, production, and maintenance; and

b) introduce new classification rules for SaMD for diagnosis or screening; monitoring; or specifying or recommending treatments for a disease or condition; or for providing therapy through the provision of information.

Currently, the amendments apply from 12 December 2019, while the classification rules apply from 25 August 2020 with transitional provisions applying for four years after that date for those sponsors who have ARTG entries prior to 25 August 2020 and who notify the TGA by 25 February 2021.

Please note - these dates are likely to be extended following an EU decision on Monday, 20 April 2020 to delay due to the pandemic.

The TGA is currently developing industry guidance to help sponsors and manufacturers understand how they can demonstrate compliance with the amended regulations. The guidance will be progressively published on the TGA website throughout 2020. You can read the amended regulations here.

Based on feedback to the 2019 consultation, the TGA is now seeking further clarification on the boundary for software-based products that could potentially be exempt or excluded so that sponsors and manufacturers are not subject to unnecessary regulatory burden, for instance, in cases where products present lower risk to safety or where products may already be subject to suitable oversight under other regulatory frameworks.

We look forward to your thoughts on the consultation paper. Please submit your response to policy@adia.org.au by close of business Monday, 11 May 2020. Feedback on the consultation paper will then be compiled and submitted on Wednesday, 13 May 2020.

As of Monday 27 April, dentistry has been rolled back to level 2 restrictions. The Prime Minister, in conjunction with the National Cabinet made this announcement at a press conference last week. The restrictions follow the framework presented to the Australian Health Protection Principal Committee (AHPPC) by the Australian Dentistry Association.

Level 2, according to these guidelines allows for the provision of dental treatments that are unlikely to generate aerosols, or where aerosols generated have the presence of minimal saliva or blood due to the use of a rubber dam.

This is great news, and though contingent on the continued availability of PPE, a sign of a gradual return to normal for the dental industry in Australia.

You can read more about Level 2 restrictions, along with the other levels and the rest of the framework for dentistry.

ENDS.

Currency Of Information & Disclaimer

This update was issued on 28 April 2020 and please note that changes in circumstances after the publication of material or information may impact upon its accuracy and also change regulatory compliance obligations. The statements, regulatory and technical information contained herein are believed to be accurate and are provided for information purposes only. Readers are responsible for assessing its relevance and verifying the accuracy of the content. To the fullest extent permitted by law, ADIA will not be liable for any loss, damage, cost or expense incurred in relation to or arising as a result of relying on the information presented here.

If you have registered your interest in the Commonwealth JobKeeper Payment, you should have received news from the Australian Taxation Office that enrolments are now open.

If you intend to make a claim for payments that fall in April, you will need to enrol before the end of the month to ensure you receive payments as early as possible. This step is additional to registering your interest, which we invited you to do when the payments were first announced by the National Cabinet.

There are a few steps involved, along with forms for both employer and employee to fill out, making it necessary for most to start the process now.

To aid in this exercise, we have summarised the steps involved and provided links below.

 

Claiming the JobKeeper Payment on behalf of your employees

1. Eligibility

• Determine the eligibility of your business to participate in the JobKeeper Payment scheme. This includes being able to demonstrate a 30% drop in turnover as a result of COVID-19.
   
• Determine the eligibility of your staff to receive payments. Each employee must have been actively employed in the business on 1 March 2020. They must be older than 16 years of age and not currently receiving any Government payments that conflict with the JobKeeper Payment.
   

2. Enrol

• Contact each employee you plan to nominate. You must ensure they are not nominated through another company, as they can only receive the payment once. Send each employee the JobKeeper Employee nomination notice. This must be returned to you by the end of the month and kept on file.
   
• Enrol the business through the ATO. There are three ways you can do this.
  
  1. Through the ATO Business Portal
  2. Using ATO Online Services through MyGov (for sole traders)
  3. Using a registered tax or BAS agent
  
  Instructions can be found here
   
• Identify and maintain your eligible employees with the ATO. There are a few different ways to do this depending on your payroll software and your number of employees. You can find instructions here.
   
• Make a business monthly declaration. You can do this through your tax agent, or via the ATO Business Portal. Each month you will need to reconfirm your eligible employees as well as make a GST turnover estimate. This is not a means test, but a measure of business progress under the JobKeeper Payment scheme.
   

3. Payments

• Payments will be made to employers via the bank details provided in their enrolment form.
   
• JobKeeper payments are paid to employers in arrears.
   
• Employers must pay their employees (a minimum of $1500 per fortnight) during the applicable pay period and be reimbursed by the ATO. If you are claiming for the two fortnights in April, you will need to ensure your employees are paid the minimum before the end of this month.
   
• In order to remain eligible for the JobKeeper Payment, employers must continue to pay nominated employees a minimum of $1,500 per fortnight, regardless of their normal earnings.
   
• The JobKeeper Payment is considered assessable income for the business receiving the subsidy and normal deductibility rules apply. The payments are not subject to GST.
  
   

 

Important things to note:

To ensure you receive payments as early as possible you should enrol by the end of April. However, enrolments are open until the end of May if you need more time.

If any employees leave your business during the duration of the JobKeeper Payment scheme, you must make the ATO aware. This can be done through the business monthly declaration.

The Federal Government have announced the intention that Superannuation guarantee payments will not be required on JobKeeper Payments. However, these rules are still in development. The ATO will update registered JobKeeper businesses when the changes are made.

If your employees have been stood down and are currently receiving other payments eg. Job Seeker, they must contact Services Australia to let them know you have applied for JobKeeper on their behalf in order to avoid a payable debt.

I will continue to bring relevant information regarding the JobKeeper Payment and any other Government measure as it becomes available.

Should you have a question you would like answered in an update, please send it through here.

 

Currency Of Information & Disclaimer

This update was issued on 21 April 2020 and please note that changes in circumstances after the publication of material or information may impact upon its accuracy and also change regulatory compliance obligations. The statements, regulatory and technical information contained herein are believed to be accurate and are provided for information purposes only. Readers are responsible for assessing its relevance and verifying the accuracy of the content. To the fullest extent permitted by law, ADIA will not be liable for any loss, damage, cost or expense incurred in relation to or arising as a result of relying on the information presented here.

This publication is available for your use under a Creative Commons Attribution 3.0 Australia licence, with the exception of the ADIA logo, other images and where otherwise stated.