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Exporting a ventilator: A fact sheet for Australian sponsors and manufacturers

31 January 2021

Pathways to exporting a ventilator

There are three pathways to exporting a ventilator from Australia:

  1. Gaining TGA Approval for the ventilator - Including the device in the Australian Register of Therapeutic Goods (ARTG) with the correct classification under the Australian regulatory requirements.
  2. Export only - Including the device in the ARTG as a Class I Export Only device. Class I (Export Only) devices are not subject to comprehensive assessment by the TGA and cannot be sold within Australia. This pathway may be considered by manufacturers who have supplied ventilators under the Therapeutic Goods (Medical Devices - Ventilators) (COVID-19 Emergency) Exemption 2020. Class I (Export Only) requires a declaration to be made regarding the devices safety and performance.
  3. Charitable donation for export only - Using the exemption for devices supplied for non-commercial purposes (i.e. devices are donated for humanitarian or charitable purposes).

Note

If you are intending to export your devices, you should also consider the requirements of the importing country.

Ventilators supplied to hospitals under the Therapeutic Goods (Medical Devices—Ventilators) (COVID-19 Emergency) Exemption 2020 were not TGA approved or included on the ARTG, and therefore cannot be exported. This exemption commenced on 8 April 2020 and ceased on 31 January 2021.

1. Gaining TGA approval so that the ventilator can be sold in Australia or exported

Ventilators sold in Australia must meet Australian regulatory requirements and be included in the Australian Register of Therapeutic Goods (the ARTG). This means the device:

  • will be classified as a Class IIa or IIb device; and
  • will need to have a conformity assessment certificate issued by the TGA (or a European notified body or other recognised comparable regulator). This certificate demonstrates that the device:
    • is manufactured under a suitable quality management system; and
    • meets safety and performance requirements known as the Essential Principles.

Note

If you are considering applying for Conformity Assessment through the TGA please familiarise yourself with the expected application processing timeframes and relevant fees.

The essential principles checklist will help you document compliance with the principles. Completing this checklist will assist when you commence the conformity assessment certification process.

If you have a conformity assessment certificate and would like to supply your ventilator in Australia you need to include your device in the ARTG. The medical device inclusion process guidance provides a step-by-step guide to help you.

2. Export only - Including the device in the ARTG as a Class I (Export Only) device

If you do not intend to supply your ventilator in Australia, but instead wish to export the ventilator to other countries, you must include the ventilator on the ARTG as a Class I (Export Only).

Class I (Export Only) devices are:

  • not reviewed by the TGA before processing;
  • processed within a matter of days; and
  • supported by a self-certification (declaration) made by you that you can demonstrate that the device meets the essential principles.

Note

Importing countries are aware that Class I (Export Only) devices have not undergone independent assessment by the TGA (or a European notified body or other recognised comparable regulator), and may not have undergone an appropriate level of assessment under the Australian regulatory framework to ensure the device is safe and fit for its intended purpose.

For this reason, some countries will not import Class I (Export Only) devices.

Export only - Declaration for Class I (Export Only)

While you do not need a conformity assessment certificate from the TGA (or a European notified body or other recognised comparable regulator), the manufacturer of a Class I (Export Only) device will need to make a declaration of conformity (DoC).

The DoC can be in any format, but it must include the following information:

  • Name and address of the manufacturer.
  • Identification of the product (name, type number or model number, or serial number).
  • Reference to conformity assessment procedure Part 6, (clause 6.6.), which is the DoC you are making.
  • A list of harmonised standards/methods you have used to demonstrate that the device meets the essential principles.
  • The date of issue of the declaration.
  • The signature and title of the manufacturer's CEO or equivalent.

Note

DoC templates are available. Class I (Export Only) devices should use the template under Schedule 3, Part 6, Clause 6.6).

Note: It is an offence to submit false or misleading information in a declaration to the Commonwealth Government.

By signing the DoC, the manufacturer is declaring that they have prepared technical documentation for the device demonstrating that it meets the essential principles.

Technical documentation includes, but is not limited to:

  • Design diagrams or drawings, including any components, sub‑assemblies or circuits.
  • The test protocols and results to demonstrate performance, biocompatibility, stability, and sterility (if applicable).
  • A list of any tests conducted to relevant standards.
  • Clinical evidence (i.e literature review, clinical trial, post market data).
  • Risk management documentation (e.g. per ISO 14971).
  • Labelling and Information For Use (IFU) (i.e displaying ‘For export only' if applicable)

The manufacturer must maintain records and provide evidence to substantiate any claims made within the DoC if requested by the TGA.

Advertising claims

Any advertising material or information provided with a Class I (Export Only) device must not imply endorsement, or approval, by the TGA or a government authority.

You must also make it clear that the device is a Class I (Export Only) device and not imply that the device can be sold within Australia.

Export only - Applying for a Class I (Export Only) ARTG entry

Once you have completed the DoC, you can apply to include your Class I (Export Only) device in the ARTG. Step-by- step instructions are available.

Note in particular:

Note

  • The DoC signed by the manufacturer will need to be uploaded with the application; and
  • there will be an applicable application fee.

Export only - Ongoing responsibilities

If you have a Class I (Export Only) device, there are ongoing responsibilities and conditions of inclusion. Detailed information about these obligations can be found on the “Post market” tab of the Australian Regulatory Guidelines for Medical Devices (ARGMD).

Your ongoing responsibilities include, but are not limited to:

3. Charitable donation - Exporting for non-commercial purpose

You are able to export a device without including it in the ARTG if the device is generally to be donated and only used for humanitarian purposes (i.e. on a non-commercial basis). Specifically the device:

  1. is not intended for commercial supply;
  2. does not contain a substance the export of which is prohibited under the Customs Act 1901; and
  3. is not intended for use for experimental purposes on humans.

For more information, see Schedule 4, Part 1.1 of the Therapeutic Goods (Medical Devices) Regulations 2002

Requirements of the importing country

This fact sheet contains information about the legal export of devices from Australia. Importing countries may have further requirements, including the need for a Certificate of Free Sale/Export Certificate. These are available from the TGA after you have included your devices on the ARTG, and is subject to a processing fee.

Note

The TGA does not track individual requirements for other countries around the world. We strongly recommend that you contact the country of import through their consulate or embassy to determine their specific requirements.

For further information

For general enquiries and more information about therapeutic goods, you can contact the TGA.

For specific enquiries relating to medical devices, including IVDs, you can contact the Medical Devices Information Unit.