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 for Australian corporations applying to become an Australian Conformity Assessment Body (CAB) for medical devices, including IVDs.
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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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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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User guideNotifying us of any medical device Conformity Assessment certification lapse is a legal requirement.
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GuidanceGuidance on ARTG and Conformity Assessment requirements for immunohaematology reagents (IHRs).
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GuidanceGuidance on how to interpret Essential Principle 13B and how it applies to your device.
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GuidanceGuidance for manufacturers and sponsors on cyber security of medical devices that include software or electronic components.
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PageInformation on Conformity 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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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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PageTo help sponsors apply for permission to import, supply, or export medical devices that do not fully comply with one or more Essential Principles for a limited period.
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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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GuidanceGuidance explaining regulatory requirements for in-house in-vitro diagnostic medical devices (IVDs).
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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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GuidanceGuidance for sponsors and manufacturers on regulatory responsibilities associated with first aid kits supplied using the special Conformity Assessment procedure.
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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 for manufacturers outlining the procedures for submitting Conformity Assessments and declarations of conformity for in-vitro diagnostic devices (IVDs)
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GuidanceGuidance explaining sponsor requirements for IVD Conformity Assessment through manufacturer agreements and regulatory compliance.
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 Medical Device Single Audit Program (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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GuidanceGuidance for preparing a technical file review, as part of your application to include an in-vitro medical device (IVD) 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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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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FormsApply for a Certificate of Free Sale or an Export Certificate for a medical device.
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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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PageClinical evidence guidelines: medical devices have been finalised and are now available
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GuidanceManufacturers are responsible for maintaining evidence that their devices comply with the Essential Principles.
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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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PageThis page outlines requirements for medical devices that use Artificial Intelligence (AI) and machine learning.
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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 understand how we interpret regulations and how manufacturers can comply with them.
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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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GuidanceThis guidance is to help sponsors and manufacturers of in-vitro diagnostic (IVD) medical devices transition to new manufacturer evidence requirements.
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GuidanceGuidance to assist researchers who are developing new medical devices understand the evidence requirements for market authorisation.
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GuidanceGuidance on the regulatory framework for in vitro diagnostic (IVD) companion diagnostics (CDx) and for the medicine or biological that requires CDx testing.
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GuidanceThis guidance is for sponsors of applications for inclusion of medical devices, including in vitro diagnostic (IVD) devices, in the Australian Register of Therapeutic Goods (ARTG).
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GuidanceThis guidance explains how overseas assessments can support our medical device certification and registration processes.
Inspections
Learn how TGA conducts inspections of manufacturing sites.
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FormsFind further information about inspection and audit feedback forms.
Product types