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Exemption to enable the domestic manufacture and supply of ventilators

25 April 2020

On 8 April 2020 the Therapeutic Goods (Medical Devices—Ventilators) (COVID-19 Emergency) Exemption 2020 was made to support the Australian Government's rapid response to the COVID-19 emergency by facilitating access to medical devices to treat patients requiring invasive ventilation.

The new emergency exemption is in effect until 31 January 2021 and is applicable to ventilators that are not already included on the Australian Register of Therapeutic Goods (ARTG) in the name of the manufacturer and can demonstrate compliance with minimum technical requirements. The exemption does not permit the general supply of these ventilators to healthcare facilities or consumers outside the context of the COVID-19 emergency.

Ventilators supplied under this exemption must:

  • be manufactured domestically in Australia;
  • only be supplied to Australian healthcare facilities only and only used during the COVID-19 pandemic, and prior to January 2021; and
  • meet the specifications and testing requirements published in Ventilator for COVID-19 use in Australia.

The following guidance covers:

Note

Ventilators supplied under this exemption are only intended for use when purpose-made ICU ventilators, included on the ARTG, are not available.

Manufacturers who are not seeking to supply ventilators via the ventilator exemption should follow guidance for manufacturing medical devices for COVID-19.

Manufacturing under the exemption

If you are a domestic manufacturer intending to supply ventilators under this exemption you must declare this to the TGA and provide documentation demonstrating that your device meets the requirements set out in the ventilator exemption. Following review of this documentation, the TGA will write to you, giving permission to supply to Australian hospitals.

The TGA has developed the following documentation to assist you:

How to access a Word document

  1. Features and risk assessment checklist (docx,34kb)
  2. Test procedures and results template (docx,84kb)
  3. Declaration that the device has been manufactured in accordance with the minimum technical requirements (docx,61kb)
  4. Instructions for Use checklist (docx,35kb)

Completing this documentation will help you demonstrate that:

  • the ventilator has the required features and meets both the minimum specifications and the testing requirements, or in areas where it does not, the manufacturer has put in place appropriate risk mitigation, and
  • any design and manufacturing risks have been assessed and mitigated.

Once you have completed your documentation you will need to submit the following documents to DCAS@health.gov.au for review:

  1. Features and risk assessment checklist (docx,34kb)
  2. Test procedures and results template (docx,84kb)
  3. Declaration that the device has been manufactured in accordance with the minimum technical requirements (docx,61kb)

The TGA will review your documentation and, if suitable, provide permission to supply your ventilators to Australian healthcare facilities.

Note

If you are not able to meet some of the test standards in these documents, you may still be able to supply your ventilator providing that it can still be demonstrated that the specification is met.

Please contact DCAS@health.gov.au with information about the tests you are unable to meet along with any evidence you can supply to explain how the risk of not meeting them has been mitigated.

Permission to supply

The TGA will review the information you have provided and if it demonstrates adequately that your ventilator meets the specification, the TGA will write, notifying you of permission to supply.

The TGA will publish a list of all ventilators it has given permission to supply, under the COVID-19 ventilator exemption.

Ongoing obligations

If you receive permission from the TGA to supply your device, you will have ongoing obligations including:

Reporting requirements

You must notify the TGA within 48 hours (if the incident is a serious threat to public health) or within 10 days after becoming aware of:

  • any malfunction or deterioration in the characteristics or performance of the device;
  • any inadequacy in the design, production, labelling or Instructions for Use; and
  • any use of the ventilators that might lead, or might have led, to the death of a patient or a user of the device in Australia, or to a serious deterioration or serious injury to his or her state of health.

Note

All reports should be sent to IRIS@health.gov.au. For additional information on what should be reported and how to report an incident, please see Medical Device Incident Reporting Investigation Scheme (IRIS).

Please also see Adverse event reporting.

Record keeping requirements

You must keep records of the manufacture and supply of your ventilators, and this information must be made available to the TGA upon request. You should record:

  • details of any post-market activities undertaken after the device was supplied in Australia;
  • details of any changes or variations to the device and/or quality management system;
  • details of your quality management system;
  • the design, production process and intended performance of the ventilator; and
  • distribution records (for more information see Distribution Records), supply figures must be provided to the TGA on a monthly basis, from the date permission is given.

Please see Manufacturer's ongoing responsibilities for additional information.

Inspections, testing and recalls

In addition to reporting and record keeping, you must also engage with the TGA when requested for the purposes of inspections, testing and recall activities.

Inspections

Upon request from the TGA, you must allow an authorised person from the TGA to enter (at a reasonable time) any premises relating to the manufacture of the ventilators in order to:

  • inspect the premises and the ventilators; and
  • to examine, take measurements of, conduct tests on, or require tests to be conducted on, the ventilators.

Testing

You must also supply a representative sample ventilator for examination when requested in order to demonstrate compliance with the minimum technical requirements if requested by the TGA.

Recalls

You must notify the TGA of any technical or medical reason for a malfunction or deterioration that has led you to take steps to recover or recall ventilators that have been supplied. In the event that a recall or corrective action is required, you must also comply with requests made to you by the TGA. Corrective actions include: changes to device design; construction and information accompanying the device; suspension and/or cancellation of the product; recall actions including safety alerts and educational resources including website notifications.

Please see Australian recall actions and the Uniform Procedure for Therapeutic Goods (URPTG) for more information about recall actions that may be taken.

Note

There are criminal and civil penalties for breaching the conditions of the exemption. They are outlined in section 41MNB, 41MNC and 41MND of the Therapeutic Goods Act 1989.

For further information on the novel coronavirus (COVID-19), please see the Department of Health and TGA websites.