To manufacture system and procedure packs in Australia, you must meet safety, quality and performance requirements.
Understanding these rules can help you manage your supply chain risks and meet your legal obligations.
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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GuidanceGuidance detailing self-certification procedures for Class I non-measuring, non-sterile non-IVD medical devices; Class 1 IVD medical devices; some systems and procedure packs; medical devices for export.
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GuidanceThis guidance applies to manufacturers of medical devices that are regulated as system or procedure packs and supplied using the special conformity assessment procedure regulatory pathway.
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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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GuidanceGuidance for sponsors and manufacturers on regulatory responsibilities associated with first aid kits supplied using the special Conformity Assessment procedure.
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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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