If you’re producing personal protective equipment (PPE) like masks, gloves or gowns for therapeutic use, you must meet regulatory requirements.
Supply and distribution must protect product integrity during storage, handling and transport. If you import or export PPE, you must meet Australian regulations and maintain proper documentation.
Understanding these requirements helps you meet your legal obligations and mange risks through the supply chain.
You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information specific to medical devices. You may also have to meet obligations that apply to all medical devices and all products.
Supply
Understand your obligations to manage the ongoing supply of products.
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PageInformation for sponsors conducting market actions for therapeutic goods in Australia.
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PageGuidance on legally supplying medical devices in, and exporting them from, Australia.
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GuidanceGuidance for manufacturers of medical devices considering supplying the instructions for use of their device in an electronic or online format.
Import and export
Access requirements for import and export of therapeutic goods.
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PageTo export medical devices, including in-vitro diagnostic medical devices (IVDs) and other therapeutic goods (OTGs), you must meet requirements set out in the Australian therapeutic goods legislation.
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PageInformation on the different types of face masks and respirators.
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PageInformation for health professionals importing and supplying medical devices.