Yesterday the Premier announced a State of Disaster for Victoria commencing at 6pm. Melbourne has also moved to Stage 4 restrictions and regional Victoria (including the Shire of Mitchell) will be on Stage 3 restrictions.
 

Today the Premier expanded further on the restrictions and advised further details will be provided during this week. The restrictions are being implemented to limit the movement of people, and therefore limit the movement of this virus.
 

There will be three lists that will apply during Stage 4 restrictions.

1. Supermarkets, grocery stores, bottle shops, pharmacies, petrol stations, banks, newsagencies, post offices, plus everyone involved in the frontline response, will continue to operate.

2. Industries which will be required to cease operations include retail, some manufacturing and administration. These businesses will all need to close by 11:59pm Wednesday 5 August. Information on industries effected will be provided later in the week.

3. The final list is made up of industries that are permitted to operate but under significantly different conditions. Information on industries effected will be provided later in the week.
 

Warehousing and distribution centres in Melbourne will be limited to no more than two-thirds the normal workforce allowed onsite at any one time.
 

All open businesses and services will have until 11:59pm Friday 7 August to enact a COVIDSafe plan focused on safety, prevention, and response if coronavirus is linked to the workplace. We previously provided information on how to become a COVIDSafe plan and it can be sourced here.

For those businesses that suffer significant losses or need to close due to the current restrictions, the Victorian Government will provide support through expanding the Business Support Fund. Businesses in regional Victoria can apply for a $5,000 grant while those in Melbourne and Mitchell Shire can apply for up to $10,000 in recognition of spending longer under restrictions.
 

ENDS.

Currency Of Information & Disclaimer
This update was issued on 3 August 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.

The recent surge in Coronavirus infections in Victoria has seen the implementation of a six-week stay at home order for the City of Melbourne and the Shire of Mitchell, coming into effect on 8 July. This will affect dental practices and the wider industry. 

Dental practice restrictions at level one
Along with changes to schooling, restaurants and cafes, and health and fitness, this also means a possible rollback to stricter dental practice restrictions. Currently at level one, the Australian Dental Association Victoria Branch (ADAVB) is discussing the possibility of moving to level two with the Chief Medical Officer. You can read requirements for each individual stage here. While still operating at level one, the ADAVB is recommending those practicing in 'hotspot' areas take further precautions. You can read the recommendations and latest news from ADAVB here.

Fair Work updates for Victorian restrictions
For those who need to make changes to their business to accommodate the six-week lockdown, the Fair Work Ombudsman has released further information and resources since the announcement. While much of the information remains the same as last lockdown, it is important to note, provisional laws have been put in place to deal with industrial relations issues since the first lockdown, including pay and leave options during self-isolation.

Victoria - New South Wales border closure
As well as the stay at home order, this week the NSW Government has also elected to close the border between NSW and Victoria. The border between Victoria and South Australia will remain closed also. No exemptions or permissions are currently required to enter Victoria, however, if travelling from Victoria to New South Wales, a permit is required. Read more about permit categories, exemptions and how they apply to your business here.

News from ADIA - Insights Webinar Series
As part of the expansion of our online offering, ADIA is introducing the Insights Webinar Series this month. The webinars are free for members and will be held on the third Tuesday of each month (10am AEST / AEDT).

The ADIA has been very fortunate to book a varied and esteemed line up of speakers for the series.

The first webinar, to be held on Tuesday 21 July, will feature Kaixin Owyong from NAB presenting a 2020 Economic Outlook. Kaixin is an Economist in the Global Markets Research team at NAB. She has a strong track record of translating economic data into clear and insightful analysis.

Webinar 2 - Tuesday 18 August: Tracey Duffy, Therapeutic Goods Administration

Webinar 3 - Tuesday 15 September: The Hon Michaelia Cash, Minister for Employment, Skills, Small and Family Business
Webinar 4 - Tuesday 20 October:
Panel Session "What does the change in Scope of Practice mean for Industry"
Panel includes, DHAA, ADOHTA, ADPA, ADANSW and DAPA

ENDS.

Currency Of Information & Disclaimer
This update was issued on 9 July 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.

 

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.