Producing medical devices requires meeting regulatory requirements to ensure quality, safety and performance.
Manufacturers take full responsibility for the design and production of a medical device, whether they make the device themselves or subcontract some of these activities.
Some devices must be manufactured under a certified Quality Management System. 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 products.
Conformity assessment
Find conformity assessment requirements and variations.
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PageInstructions on how to apply for a Conformity Assessment certificate.
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GuidanceAn overview on the application process for manufacturers aiming to obtain a TGA-issued Conformity Assessment certificate.
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GuidanceGuidance to assist Australian corporations seeking to apply for an Australian Conformity Assessment Body (CAB) determination for medical devices (including IVDs) by the TGA.
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PageAustralian corporations can now apply to become an Australian Conformity Assessment Body (Australian CAB)
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FormsInformation and templates for manufacturers making an Australian declaration of conformity.
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User guideNotifying us of any medical device Conformity Assessment certification lapse is a legal requirement.
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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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PageRead our questions and answers for sponsors and manufacturers about the Medical Device Single Audit Program (MDSAP).
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PageGuidance on the two key requirements of the conformity assessment procedures for medical devices that a manufacturer must implement
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PageLearn about Quality Management Systems and how medical device manufacturers use them to meet their regulatory and customer requirements.
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PageRegulatory responsibilities and expectations for manufacturers of medical devices, including in vitro diagnostics (IVDs).
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GuidanceGuidance to assist manufacturers of medical devices and their component parts with meeting their regulatory obligations.
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PageThis section is for manufacturers of medical devices and IVDs.
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PageVarious regulatory requirements and processes apply to the manufacture of medical devices, including in vitro diagnostic (IVD) devices.
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PageLearn about quality management systems and medical devices.
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PageGuidance for medical devices manufacturers on how we conduct Quality Management System (QMS) audits, roles and responsibilities for audits, aspects of conformity assessment certification and post-audit activities.
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PageGain an understanding of commonly identified nonconformities during TGA audits
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PageOur approach to delays in overseas and Australian Conformity Assessment recertifications due to the COVID-19 pandemic and the implementation of the EU MDR/IVDR.
Auditing
Learn how TGA conducts manufacturing audits and understand your obligations.
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PageRead our questions and answers for sponsors and manufacturers about the Medical Device Single Audit Program (MDSAP).
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FormsFind further information about inspection and audit feedback forms.
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PageThe MDSAP allows recognised organisations to audit device manufacturers in a single program that satisfies the requirements of the participating regulatory authorities.
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PageGuidance for medical devices manufacturers on how we conduct Quality Management System (QMS) audits, roles and responsibilities for audits, aspects of conformity assessment certification and post-audit activities.
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PageGain an understanding of commonly identified nonconformities during TGA audits
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GuidanceGuidance for sponsors of medical devices seeking to include a medical device (including in vitro diagnostic devices) in the Australian Register of Therapeutic Goods (ARTG).
Certification
Access information on applying for or varying certification.
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PageInstructions on how to apply for a Conformity Assessment certificate.
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GuidanceAn overview on the application process for manufacturers aiming to obtain a TGA-issued Conformity Assessment certificate.
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GuidanceThis guidance is to assist you to apply for a Certificate of Free Sale or an Export Certificate for medical devices, including in-vitro diagnostic medical devices (IVDs) and Other Therapeutic Goods (OTGs).
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GuidanceGuidance for notifying the TGA about substantial changes to, or transfers of, Conformity Assessment certificates.
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User guideNotifying us of any medical device Conformity Assessment certification lapse is a legal requirement.
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PageThe Conformity Assessment certification and audit requirements for certain medical devices have changed.
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PageInstructions for printing your certificate of inclusion in the Australian Register of Therapeutic Goods.
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PageGuidance for medical devices manufacturers on how we conduct Quality Management System (QMS) audits, roles and responsibilities for audits, aspects of conformity assessment certification and post-audit activities.
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PageAbout revocation of TGA issued conformity assessment certificates.
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PageOur approach to delays in overseas and Australian Conformity Assessment recertifications due to the COVID-19 pandemic and the implementation of the EU MDR/IVDR.
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FormsTransfers of conformity assessment certificates.
Evidence
Access evidence requirements for manufacturing medical devices.
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PageInstructions on how to apply for a Conformity Assessment certificate.
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PageInformation on Australian evidence options including TGA conformity assessment certification.
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GuidanceManufacturers are responsible for maintaining scientific and engineering evidence that shows that their devices comply with the Essential Principles (the Principles).
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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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PageUnderstand what evidence is needed to have a medical device included in the Australian Register of Therapeutic Goods (ARTG).
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PageYou may be able to use overseas evidence to have your medical device included in the Australian Register of Therapeutic Goods (ARTG).
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PageInformation about the types of Real World Evidence (RWE) relevant in the Australian, for sponsors and manufacturers.
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PageAbout revocation of TGA issued conformity assessment certificates.
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PageOur approach to delays in overseas and Australian Conformity Assessment recertifications due to the COVID-19 pandemic and the implementation of the EU MDR/IVDR.
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GuidanceGuidance to assist researchers who are developing new medical devices understand the evidence requirements for market authorisation.
Inspections
Learn how TGA conducts inspections of manufacturing sites.
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FormsFind further information about inspection and audit feedback forms.
Product types