Producing and supplying personal protective equipment requires meeting regulatory standards to ensure safety and quality.
Devices must be manufactured under a certified Quality Management System (QMS). They must also comply with the Essential Principles to ensure safety and performance.
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.
Conformity assessment
Find conformity assessment requirements and variations.
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FormsInformation and templates for manufacturers making an Australian declaration of conformity.
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PageConformity Assessment, Essential Principles and consent to supply.
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PageGuidance and links to information on Conformity Assessment for medical devices.
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PageNew features have been launched for the Medical Devices Consent for Non-compliance Dashboard in TBS Business Services Portal.
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PageGuidance on the two key requirements of the conformity assessment procedures for medical devices that a manufacturer must implement
Certification
Access information on applying for or varying certification.
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GuidanceGuidance for notifying the TGA about substantial changes to, or transfers of, Conformity Assessment certificates.
Evidence
Access evidence requirements for manufacturing medical devices.
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PageHow to apply for inclusion of face masks (including respirators), that are medical devices, in the Australian Register of Therapeutic Goods (ARTG).
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PageA Manufacturer Evidence application must be submitted and accepted by the TGA before you can commence an application for any medical device.
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PageMedical device and in vitro diagnostic (IVD) applications require a Manufacturer's Evidence application.
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GuidanceGuidance to assist researchers who are developing new medical devices understand the evidence requirements for market authorisation.
Product types