MTAA COVID-19 update

14 May 2020

Freight update

Additional flights have been arranged through the International Freight Assistance Mechanism (IFAM).

There is capacity inbound from Auckland, Hong Kong, Tokyo (Narita) and Singapore in which medical supplies will be prioritised.

Please see the Qantas flight schedule and Singapore Airlines schedule for flight numbers, days of operation, departure and arrival times.

Members will need to work with their freight forwarders in order to access freight space. If members require additional assistance and suggestions of freight forwarders based with medical and market expertise, Austrade is able to provide this.

For any further assistance or questions, please feel free to contact or Austrade directly at airfreight@austrade.gov.au.

 

Essential Traveller Update – QLD

Due to changes in restrictions, returning QLD residents must apply online for a Queensland Entry Pass, which can be accessed here. The new passes are applicable to a person rather than a vehicle, as was the case with the previous pass.

 

Government releases Roadmap to a COVIDSafe Australia

The Federal Government has released ‘Roadmap to a COVIDSafe Australia’, a three-step pathway for easing restrictions. Read more here.
 

NCCC business COVIDSafe plan toolkit

The National Covid-19 Coordination Commission has released a guide for business to develop a COVIDSafe plan. The guide can be accessed here.

 

JobKeeper Payment Guide

ACCI has released an updated JobKeeper Payment Guide to assist employers. The information guide seeks to explain and answer some of the more common questions employers may have around the payment scheme and it can be accessed here.

 

Elective Surgery – South Australia to resume

South Australia will become the first state to begin to fully restore elective surgery with the lifting of the Appropriate Surgery Direction under the Emergency Management Declaration. Read media release here.

 

National Measurement Institute helping the health and manufacturing industry respond to COVID-19

The Department of Industry, Science, Energy and Resources has just published a news story on their website regarding the National Measurement Institute and how they are helping the health and manufacturing industries to respond to the COVID-19 pandemic.

You can view the full news story here.

 

Applications open for COVID-19 research grants

Guidelines and application details for round one of the NSW Heath COVID-19 Research Grants are now available on the NSW health and medical research website.

Round one applications close on 20 May 2020. Apply here.


Free and discounted training courses available to MTAA members

In response to the impact of COVID-19 on our members, we are providing a number of training courses free or at a 25% discount. Please see the MTAA website for more information.


6 May 2020

Essential Traveller update

MTAA is continuing to work on addressing issues faced by members around interstate travel restrictions, however, we have received feedback from a number of member companies that in most cases, restrictions can be addressed by providing the relevant documentation. We recommend that medtech employees carry with them, as a minimum:

  • Physical copies of any documentation specifically required by the state to which they are travelling, links available on MTAA website;
  • A letter from their employer; and
  • A letter from the relevant customer (ie the hospital to which they are travelling).

MTAA is able to provide a letter confirming MTAA membership and completion of OTP course if required. We can also provide a template letter to assist with identification purposes for staff of member companies. Please contact Peter Tustin for further assistance: ptustin@mtaa.org.au.

 

Freight Update

On 23 April, the Government announced a new network of 15 air freight service providers and freight forwarders to accelerate the delivery of agricultural and fisheries exports to key overseas markets. On return, these flights will bring back medical supplies, medicines and equipment to support Australia’s COVID-19 response. The $110 million International Freight Assistance Mechanism (IFAM) is to provide assistance to exporters and re-establish global supply chains.

Further information on the International Freight Assistance Mechanism is available here. For more information about importing medical supplies, please contact airfreight@austrade.gov.au.

 

Austrade Medical Imports contact
Mrs Emily Bogue is the head of the office’s medical imports team and is working for the new International Airfreight Coordinator General. Her email contact is: Emily.Bogue@austrade.gov.au. There is also a general inbox: Airfreight@austrade.gov.au.

The Office of the International Airfreight Coordinator General is managing requests to assist in the import of medical goods and PPE including medical devices and their components for machines like ventilators and may be able to assist with international freight needs. The Office has specific templates to help match industry demand to available services that they are operating. The office also has embedded officers and logistics experts from Qantas and Virgin, and also operates a panel arrangement with a number of key freight forward operators and international airline contractors in the service of their program. If they are unable to assist with specific requests they may be able to connect people with appropriate industry contacts that can support commercial terms.

You can read the media release here.

 

MTAA freight working group
MTAA has established a specialist freight group as part of MTAA’s COVID-19 Working Group structure. The purpose of the group is to provide a summary of issues and freight route priorities to feed directly into Austrade’s weekly panel meetings.

Please contact Paul Dale if you would like to be part of this.

 

Update: ACCC interim authorisation

As part of MTAA’s COVID-19 effort, a conditional authorisation (AA1000479) was successfully obtained from the ACCC to enable industry to collaborate in supporting the Commonwealth to secure medical supplies throughout the COVID-19 pandemic.

The ACCC have advised MTAA that, as part of their review, they will be contacting the companies listed on the conditional authorisation (AA1000479) to request feedback on how the authorisation is working. MTAA encourages companies to provide a response, particularly those companies that are actively involved in the COVID-19 working groups.

 

NSW Government COVID-19 Emergency Supplies Portal

The NSW Government has recently launched the COVID-19 Emergency Supplies Portal. Businesses interested in sourcing hand sanitiser, examination gloves, disinfectant and cleaning products, handwash and soap, masks, eyewear, gowns and protective overalls and paper products including toilet and tissue paper, can access local PPE suppliers here. Businesses can continue to register their interest to supply here.

 

Standards Australia summary information on standards and conformance for PPE products

Standards Australia have recently released summary information on standards and conformance for PPE products in consultation with the Australian Technical Infrastructure Alliance, to assist in helping manufacturers identify relevant standards and find potential pathways to market. Read more here.

 

McKinsey paper on COVID & MedTech

McKinsey & Company have recently published a paper on COVID-19 and MedTech, Reimagining medtech for a COVID-19 world. You can read it here.


28 April 2020

Government assistance for the MedTech sector

MTAA wrote to Minister Hunt on 29 March outlining the very significant pressures facing the medical technology industry in the current environment and requesting a number of urgent measures to address the ongoing viability of Australia’s MedTech industry as the COVID-19 crisis continues.

The MTAA Board met with Health Minister Greg Hunt on Friday last week to discuss this and other matters, including a return to elective surgery and additional support measures for SMEs and Australian companies. 

Following this meeting and a period of intense discussions between MTAA and Minister Hunt and his office, a number of measures have been confirmed by the Minister in relation to PL reform.

 

Jobkeeper update

MTAA has been liaising with the Australian Tax Office (ATO) in order to seek clarity on the Jobkeeper provisions available to medtech companies, particular in relation to small companies where they are a local branch of a global company.

The ATO have clarified that, in determining whether a company must show a 30% or a 50% reduction in turnover, the global revenue of the global entity of which it is a part is included. If the global entity exceeds $1b, at least a 50% reduction must be demonstrated to qualify.

However, once the threshold is set, the turnover test itself is based on local GST revenue, not global revenue. Therefore, a small company which is a local branch of a global company exceeding $1b in revenue in total would still need to show that Australian turnover has fallen more than 50% to qualify for JobKeeper.

If global revenues were less than $1b, the fall in Australian turnover would only need to be 30% to qualify.

 

Freight group – call for EOIs

MTAA is calling for expressions of interest from those interested in joining a specialist freight group as part of MTAA’s COVID-19 Working Group structure.

The purpose of the group would most likely be to provide a summary of issues and freight route priorities to feed directly into Austrade’s weekly panel meetings. It is envisaged that a representative from Austrade would be part of the group.

Please contact Paul Dale if you would like to be part of this.


 

21 April 2020

Elective Surgery to resume after Anzac Day

Prime Minister Scott Morrison has announced that elective surgery will begin to gradually re-start after the Anzac Day long weekend.

National Cabinet met this afternoon and agreed that category two surgeries and selected category three surgeries will start from Monday, with a review on May 11 to determine if and when more restrictions will be lifted.

Click here to read the Department of Health media release.

 

Essential Traveller update – South Australia

The South Australian Government has published an updated link to their essential traveller guidelines, available here. The guidelines now include a formal written clarification around ‘health services’.

2—Health services

Persons who are requested by the Chief Executive of the Department for Health and Wellbeing, or by the Secretary of the Commonwealth Department of Health, or by the delegate of either, to assist in the provision of health services in South Australia and who are required to be physically present in South Australia in the conduct of those duties.

Note—

This means that South Australian health care workers who wish to provide services in another State or jurisdiction will be required to undertake a 14-day quarantine period on their return to South Australia. The only exception is a person who falls within the terms of this clause.

If you require further information you can call the SA COVID-19 Information Line on 1800 253 787 between the hours of 8am to 8pm seven days a week or go to the SA Health website at www.sahealth.sa.gov.au or www.sa.gov.au/covid-19

 

EU-MDR Update

EU Parliament decides to postpone implementation of new Medical Devices Regulation by one year

On Friday April 17th the EU Parliament decided to postpone implementation of the new medical devices and in vitro medical devices regulations 2017/745 (MDR) and 2017/746 (IVDR) by one year. The new regulations entered into force in May 2017 with a transitional period for full enforcement of 3 years for the MDR (i.e. until May 2020) and 5 years for the IVDR (until May 2022).

Due to the current pressure on national health authorities, manufacturers and suppliers of medical devices to address COVID-19 priorities, the European Parliament has decided to postpone the deadline for full enforcement of the MDR by one year to allow authorities and manufacturers alike to prioritise the fight against the coronavirus pandemic. Read the full EU Parliament press release here.

The Australian policy is to remain aligned with the EU medical device regulations and TGA has already started to take steps aligning with the new EU MDR, such as adopting requirements for patient implant cards and information leaflets and up-classifying certain medical devices. As the majority of medical devices included in the ARTG rely on a EU CE Marking approval, it is important that Australian timelines for implementation of regulatory requirements aligning with the EU MDR take into consideration this latest deferment of deadlines.

MTAA continues to work closely with the TGA to ensure that local supply of medical technology is not adversely affected by ongoing COVID-19 challenges and changes in regulatory framework.

 

Global Medical Technology Alliance Updates

GMTA Proposal for a COVID-19 Thought Partnership Forum

The Global Medical Technology Alliance (GMTA) has unanimously supported a proposal to establish a thought-partnership forum to provide advice, consultation and a coordination mechanism between key global manufacturers of critically needed equipment, the WHO and other multilateral organizations. Read more here.

GMTA Cross-industry Statement in Response to Mexican UN Resolution on COVID-19

On behalf of global biopharmaceutical and medical technologies companies, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), the International Council of Biotechnology Associations (ICBA), the Global Medical Technology Alliance (GMTA), the Global Diagnostic Imaging, Healthcare IT & Radiation Therapy Trade Association (DITTA), and the Global Self-Care Federation (GSCF) welcome the initiative by the Government of Mexico to highlight the need for effective international cooperation to ensure that no one is left behind in the race against COVID-19 through the UNGA Resolution “International Cooperation to ensure global access to medicines, vaccines and medical equipment to face COVID-19” (A/75/L.56). Read more here.

 

MTAA temporary Code exemption

As the COVID-19 situation is evolving at a fast pace, MTAA understands that there will be an increased need to support Hospitals and other Healthcare settings (Healthcare Professionals [HCPs]) to ensure they have adequate supplies to be able to care for and treat patients in a healthy and safe environment.

The Code Authority Committee recommended to the Board that a temporary exemption be granted to MTAA members in relation to clause 9.9.4 of the Code of Practice Edition 11 2020 (the Code). This temporary exemption is to assist members to provide medical equipment, technologies and related services to HCPs during the COVID-19 pandemic.

When dealing with any request related to COVID-19, the principles of the Code should always be applied, but in some cases the current situation may require that principles be applied in a different way than in normal times. Therefore, it was proposed to the Board that Members be advised that responses to such requests must:

  1. Be free from any intent to improperly induce purchase of products or services;
  2. Be fully documented to allow for full transparency;
  3. Always consider the perception and the image of the industry;

NOTE: For the purposes of the temporary exemption, the company must document requests related to COVID-19 to the Code Authority. 

At the April Board meeting, the Board of Directors resolved to allow the temporary exemption of Members from Clause 9.9.4 of the Code of Practice Edition 11 for the duration of the COVID-19 pandemic.

 

ACCC exemption update

The ACCC has granted interim authorisation to MTAA to allow its members and other groups, such as suppliers or distributors of medical equipment, to share information between each other, co-ordinate orders and supply requests, prioritise requests, and jointly tender to supply COVID-19 medical equipment.

The ACCC initially granted interim authorisation to MTAA on 25th March. Subsequently MTAA has amended its application, and sought interim authorisation for the conduct described in the amended application. The ACCC has revoked the interim authorisation granted on 25 March, and granted replacement conditional interim authorisation to MTAA for its amended conduct. Read more here.

 

NSW Government PPE Survey

The NSW Government is seeking to understand the constraints the medical technology industry is experiencing with regards to obtaining personal protective equipment (PPE) or retooling to meet changed or new customer demands.  

They have developed a short survey and have requested that it be distributed to MTAA members in order to help the NSW Government target their efforts at addressing the problems for business in accessing what they need to keep their business going such as PPE, sanitiser, parts and raw materials and developing a clear picture of the impact this is having on your business operations and the industry as a whole.

The survey is available through the following survey link.

 

The story behind your pathology tests

Pathology Awareness Australia Limited (PAA) is a not-for-profit group representing approximately 95% of the Australian pathology landscape. They launched the Know Pathology, Know Healthcare initiative to help educate the Australian public about the critical role that pathology plays in our lives. Know Pathology, Know Healthcare recently launched an animation to show the story behind pathology testing. You can watch it here.


9 April 2020

International air freight options

The Department of Industry, Science, Energy and Resources is working with Austrade and other Australian Government departments to assist Australian importers and exporters in identifying available international air freight opportunities.

Air freight capacity on repatriation international passenger services to and from Auckland, Hong Kong, Los Angeles and London

To support Australian importers and exporters, Qantas and Virgin Australia are offering air freight capacity on repatriation international passenger services to and from Auckland, Hong Kong, Los Angeles and London, from Thursday 9 April 2020. 

While these services are limited, this will give Australian producers a way to obtain valuable inputs for their businesses. The return flights to Australia will bring in vital medicines, medical supplies and equipment to support Australia’s response to the COVID-19 pandemic. The confirmed international flights will operate for approximately 4 weeks.

For more information on the repatriation flights, visit:
Qantas or email freightsalessupport@qantas.com.au 
Virgin Australia or email syd.cargosales@fly.virgin.com

 

Additional freight-only flights

In addition, 55 commercial freight-only flights have also been scheduled for April, totalling 540 services for this month.

Austrade advise that the best way to access these flights is to utilise your standard freight operations channels, including your Freight Forwarder.

The Customs Brokers and Forwarders Council of Australia Inc. (CBFCA) represents members interests in international trade logistics and supply chain management service provision. You can refer to this link to help you find a freight forwarder. The International Federation of Freight Forwarders Associations (FIATA) also has a member directory that can be searched through this link.

 

Austrade

If you are unable to identify air freight opportunities through these channels, Austrade, https://www.austrade.gov.au, have established a dedicated email address for international freight enquiries: Airfreight@austrade.gov.au.

 

Australian Government’s International Freight Assistance Mechanism

For information on the Australian Government’s International Freight Assistance Mechanism to back Australia’s agriculture and seafood export sectors, visit:
https://haveyoursay.agriculture.gov.au/international-freight-assistance


31 March 2020

  • Overnight Medtronic announced they are publicly sharing the design specifications for the Puritan Bennett™ 560 (PB 560) to enable participants across industries to evaluate options for rapid ventilator manufacturing to help doctors and patients dealing with COVID-19. Read more.

  • Local success story: the US FDA has approved Abbott Labs five-minute “rapid coronavirus test” – this machine was developed in Melbourne and for the first few years of its life was exclusively manufactured in Dandenong by SRX. The machine, IDNow, was originally developed for Alere and production was moved from SRX after Alere was purchased by Abbott. Read more.

  • MTAA member Gelworks is setting up to start manufacturing hand sanitiser to help out with the local shortage. Read more.

 

3DMeditech available for local device, part and component collaborations

We are all aware that the ongoing Coronavirus (COVID-19) global health emergency has resulted in acute shortages of key medical devices and component parts. These shortages could be caused by unprecedented demand, logistics constraints or even export controls in the jurisdiction of manufacture. 

Early reports from Europe and North America indicate that 3D Printing is uniquely capable of rapid local deployment to assist in preventing these shortages.  However, when doing so, ensuring that the highest levels of clinical, engineering, regulatory and supply certainty are met is essential.

Based in Melbourne, 3DMEDiTech (www.3dmeditech.com) operates one of the only – and certainly the largest – ISO13485 certified medical 3DPrinting manufacturing facilities in Australia. Read more.

 

Fumigation of testing kits

We have been advised that any Customs Broker or Importer that has a consignment that contains COVID-19 diagnostic kits or related goods for Coronavirus that is subject to Brown marmorated stink bug (BMSB) may contact the Seasonal Pest Policy team at SPP@agriculture.gov.au and they will manage the consignment on a case by case basis.

 

Media Release - Clinical trials are critical in COVID-19 fight

In support of the clinical trials sector during the COVID-19 pandemic, a position statement has been developed by the Research and Development TaskForce (RDTF), sponsored by AusBiotech, Medicines Australia, and the Medical Technology Association of Australia, together with respective memberships. Read more.

 

Request for Member information - freight

If you are experiencing difficulties with securing freight routes please contact Rachel Fry: rfry@mtaa.org.au. We are in the process of compiling information on this to escalate to government.


25 March 2020

MTAA is working closely with federal and state governments to ensure that the manufacture and supply of life-saving medical technology is maintained throughout the COVID-19 pandemic response.

In addition to providing daily updates to Health Minister Greg Hunt and Industry Minister Karen Andrews, MTAA is a member of the Coronavirus Industry Roundtable which is meeting regularly to discuss and address supply chain issues.         

If your company has a specific issue that needs to be raised in the Roundtable process, please contact Rachel Fry at rfry@mtaa.org.au.