Australian Register of Therapeutic Goods (ARTG) is an online database of Therapeutic Goods Administration (TGA). The goods listed in this database are legalized for commercial supply in Australia and the goods which are not listed in the ARTG database cannot be sold in Australia.
Who Should Register the Medical Devices in ARTG Database?
The Australia-based manufacturer or Authorized Representative of the foreign manufacturers, termed as the “Sponsor” in Australia, should register the medical devices in the ARTG database. The Sponsor shall cross verify, if the information of goods included in the ARTG database is correct. If the goods are incorrectly listed, the Sponsor can request for the cancellation from the ARTG database. In case, the TGA identifies any incorrect entries in the ARTG list, the Agency may seek further explanation from the Sponsor.
What Kind of Information Should be Provided for the Listing?
ARTG holds the record of content and classification details of medical devices. The entry shall include, details of device name and formulation details, Sponsor (company) and manufacturer details. The Sponsor shall share a detailed description on the device like its classification, manufacturer evidence, supporting documents for inclusion and auditing application for medical devices and IVDs depending on the risk class of the device. If the devices do not meet the standards set by the TGA, they will get cancelled from the Australian Register of Therapeutic Goods (ARTG) and cannot be marketed in Australia.
What is the Process for Inclusion of a Medical Device in ARTG List?
The process for inclusion in the ARTG database varies with the class of device. Process shall begin with evaluation of the product, whether its is considered as a medical device and requires an ARTG listing, as per the TGA regulations. Based on the confirmation the below steps need to be followed- -
- Determine the class of device and identify, if the device is subject to mandatory audit requirement
- Identify the documents required to be produced to the TGA. The applicant / Sponsor can leverage the overseas approvals and conformity assessments and go for abridged assessment by the TGA. The TGA considers the approvals and certificates issued by the Notified Bodies, under the EU MDD, MDR and IVDR; Food and Drug Administration (FDA), USA; Health Canada, Canada; Pharmaceuticals and Medical Devices Agency (PMDA), Japan; Certificates issued by Auditing Organizations (AO), under MDSAP program and ISO 13485:2016 certifications
- Apply for and obtain client ID from the TGA; update the details in the TGA Business Services (TBS)
- Three (3) different sections are available, one each for Class I non-sterile, non-measuring and Class 1 IVD medical devices; Class I Medical Device (Export Only) and Class 1 IVD medical device (Export Only); all classes except, Class I non-sterile, non-measuring medical device, Class I IVD medical device and Class I medical device/Class I IVD medical device Export Only)
- Identify the right section for the device in scope and submit the required information in the sections
- The TGA will review the device details and determine the Audit requirement. There are 2 levels of audits – Level I audit and Level II audit applicable for medical devices. There is a single application audit for IVDs, also called as Technical File review. The TGA determines the applicable audit level and notify the Sponsor about the audit level and the documents to be submitted. The Sponsor shall submit the documents and pay the applicable fees to TGA
- Once approved by the TGA and included in the ARTG database, the Sponsor shall comply with the post market vigilance and monitoring requirements of the TGA and pay annual charges to maintain inclusion of device in the ARTG database.
What are the various ARTG timeframe data available in database?
The ARTG database includes, ARTG start date and effective dates. The ARTG start date is the date of initial entry of the medical device into the ARTG database. The effective date is the date of last change made to the entry and when this change is effective.
What is the TGA Fees for Inclusion of Medical Devices in ARTG?
The fees charged by the TGA for inclusion of device in ARTG varies with the class of medical devices. The agency charges $ 1,370 for Active Implantable Medical Devices (AIMD) and Class III devices; $1,060 for all classes of IVDs, Class IIa, IIb, Class I - sterile, Class I - measuring function and other Class I devices (excluding export only devices). This fee excludes application audit assessment fees for medical devices and IVDs. The audit fees varies for level 1 and level 2 application audits of Medical Devices and IVD application audits. There is a provision for reduction of audit assessment fees, provided the applications meet the predetermined criteria.
Can the ARTG Listing be Transferred to a New Sponsor?
The Sponsor can transfer the device registration and the ARTG listing to the new Sponsor. In case of change in Sponsor, the TGA shall be notified of the change. The new Sponsor will be responsible for the therapeutic goods listed in the ARTG database. Additionally, any change in the name of the Sponsor or in the company shall also be notified to the TGA.
When Does a Change in Sponsor Require a New ARTG Listing?
If the new Sponsor intends to change the name of goods, they should register the device and make an entry in the ARTG database before they are marketed in Australia. The device with different brand names will be considered as distinct goods by the TGA and requires a new registration.
What is the Legislative Basis for Changing the Name of Sponsor?
The section 10FA of the Therapeutic Goods Regulations 1990 is the legal basis for changing the name of Sponsor.
What is the Process for Changing the Name of Sponsor in ARTG Database?
The Sponsor shall submit the form – “Notification: Change of Sponsor name to TGA”, through EBS platform. The application form shall be accompanied by the declaration made by the Sponsor or any authorized person on behalf of the Sponsor.
When is an ARTG Entry Cancelled?
A therapeutic good is withdrawn from the ARTG listing, upon request received from the Sponsor to cancel the product or if the Sponsor does not pay the annual charges. The TGA may remove the goods from the database, if any safety concerns arise triggering the Regulatory action.
Once Cancelled, is it Possible to Re-instate the Therapeutic Goods into ARTG Database?
Yes, the therapeutic goods can be re-entered into the ARTG database once cancelled, due to request from the Sponsor or due to non-payment of fees. The Sponsor should request the TGA for re-entry within 90 days from date of cancellation. The Sponsor shall make all the outstanding payments and pay the application fee for re-instatement.
What is the TGA Fees for Re-instatement of the Cancelled Therapeutic Goods?
The Sponsor shall pay $ 160 for there-instatement of the first cancelled therapeutic goods. The Sponsor shall pay $ 50 for every additional product to be re-instated.
What is the Legislative Basis for the Re-Instatement of Therapeutic Goods?
The goods cancelled due to request from the Sponsor can be re-instated under the section 41GLA of the Therapeutic Goods Act 1989 and the goods cancelled for non-payment of annual fees can be re-instated under the section 41GLB of the Therapeutic Goods Act 1989.
Are you looking forward to launching your medical device in the Australian market? Would you like to gain more insight on ARTG listing procedures? Consult a regional Regulatory expert like Freyr.