TGA Medical Device Class I Update – Changes to the Australian Register of Therapeutic Good (ARTG) inclusion process for non-measuring, non-sterile Class I medical devices
What does this mean?
The TGA has changed the inclusion process by which non-measuring, non-sterile Class I medical devices are included in the ARTG. The changes came into effect October 2020.
What has changed?
- The TGA has modified the process, by which Class I inclusion applications in the ARTG are done.
- The application has been updated with additional requirements; applicants must now provide a manufacturer’s Declaration of Conformity when applying to include the device on the ARTG.
- The Manufacturer’s Declaration of Conformity form for these devices has been amended, making it more user friendly.
- Unsuccessful applications, where the TGA deemed that the device has not met all the requirements for inclusion in the ARTG will be selected for an audit. An audit maybe conducted by the TGA if there are concerns regarding the device where it appears from the application that device is;
- Not a medical device
- Incorrectly classified
- Does not comply with the essential principles
- Has not had the appropriate conformity assessment procedures applied to it
- Incorrect information provided in the application or supporting documents
- Successful application, where it is deemed by the TGA that the device meets the requirements for inclusion in the ARTG, will be notified within 4 business days of application receipt by the TGA.
Who is impacted by the changes;
What is role of a sponsor in the application process;
A sponsor is a person or company who does one or more of the following:
- Exports therapeutic goods from Australia.
- Imports therapeutic goods into Australia.
- Manufactures therapeutic goods for supply in Australia or elsewhere.
- Arranges for another party to import, export or manufacture therapeutic goods.
The sponsor or agent is responsible for applying to the TGA to have their therapeutic good (medical device) included on the ARTG. In Australia, therapeutic goods (medical devices) must be included on the ARTG before they can be sold.
To complete the process of Class I medical device ARTG inclusion, an Australian address is required. KD&A can complete the application process required to obtain ARTG inclusion for your Class I medical device.
How to know if your product is a medical device?
KD&A can help with the determination of your product and should it be included in the ARTG.
Changes will not apply to Class I IVD medical devices, Class I Export Only, and Class I IVD Export Only devices.
This change has resulted in a more detailed application process, where more information is provided by the sponsor or agent when applying for the device to be included on the ARTG. The revision of the applications will help the TGA confirm if the device classification is correct for a Class I non-sterile, non-measuring medical device. The application process will now take up to 4 days, compared to 24 hours, under the previous inclusion process.
If your organisation has any questions regarding the changes by the TGA contact KD&A, we can complete ARTG applications, provide expert regulatory consulting service to medical device and IVD companies selling on Australian and international markets.
June 4, 2020