To ensure that your product is a medical device that requires inclusion in the ARTG you need to check the following:
- Is your product a medical device or IVD medical device?
- Has your product been declared not to be a medical device?
- Is your product a good that has been excluded from regulation?
- Is your product exempt from inclusion in the ARTG?
- Is your product a therapeutic good other than a medical device?
Is your product a medical device or IVD medical device?
Does the manufacturer's intended purpose meet the definition of a medical device under section 41BD of the Act and, if applicable, the definition of an IVD medical device in the Regulations?
Check if your product has been specified a medical device under:
Note
The manufacturer is responsible for determining the intended purpose of your product. The intended purpose of the product can be ascertained from the manufacturer's instructions from use, advertising material, technical documentation, and/or project label(s)
If you change the intended purpose of the product, you will meet the legislative definition of a manufacturer and you will need to meet the manufacturer's obligations under the relevant legislation.
Has your product been declared not to be a medical device?
Check if your product is declared not to be a medical device under:
- Therapeutic Goods (Articles that are not Medical Devices) Order No.1 2017
- Therapeutic Goods (Articles that are not Medical Devices) Order. No.1 of 2010
- Therapeutic Goods (Articles that are not Medical Devices) Order No.2 of 2004
Has your product been excluded from regulation?
Check the Therapeutic Goods (Excluded Goods) Determination 2018 to see if your product has been excluded from regulation. Products excluded from regulation do not need to be included in the ARTG before they can be exported from, imported to or supplied within Australia.
Is your IVD medical device intended for self-testing and is it prohibited from supply in Australia?
To determine whether your IVD medical device is prohibited from supply in Australia for self-testing purposes, please review the following:
Is your product exempt from inclusion in the ARTG?
Medical devices that are exempt from inclusion in the ARTG are those products:
- supplied for clinical trials in Australia,
- prescribed by authorised prescribers,
- supplied under the Special Access Scheme,
- imported for personal use under the Personal Importation Scheme, or
- that are custom-made medical devices.
Is your product a therapeutic good other than a medical device?
To determine whether your product is a therapeutic good other than a medical device (e.g. a medicine) that requires inclusion in the ARTG, please review the following:
- What are therapeutic goods?
- Regulation of therapeutic goods in Australia.
- Overview of supplying therapeutic goods in Australia.
- Device - medicine boundary products.
Your product is not a medical device that requires inclusion in the ARTG if it:
- does not meet the definition of a medical device; or
- has been declared not to be a medical device; or
- has been excluded from regulation; or
- is an exempt medical device; or
- is regulated as a therapeutic good other than a medical device.
Where to next?
If your product is a medical device or an IVD medical device that requires inclusion in the ARTG go to Step 2 - Things to consider prior to application