Medical devices cannot generally be imported, supplied in or exported from Australia unless they are included in the ARTG (Australian Register of Therapeutic Goods). The Australian sponsor must lodge an application to include a device or devices in the ARTG using eBS (Electronic Business Services).
Only an Australian sponsor can apply to include an IVD (In Vitro Diagnostics) in the ARTG. A sponsor can apply to include an IVD in the ARTG if: the device complies with the Essential Principles, and an appropriate conformity assessment procedure has been applied to the device. Depending on the type of IVD to be included in the ARTG, slightly different processes need to be followed.
The process for lodging an application for inclusion in the ARTG requires the sponsor to undertake the following, in accordance with Section 41FC of the Act:
- 1. Complete the appropriate application form;
- 2. Submit the completed application to the TGA;
- 3. Pay the prescribed application fee;
- 4. Ensure that, if a conformity assessment certificate is required for the device, the appropriate certificate has been obtained before lodging the application for inclusion of the IVD in the ARTG;
- 5. Ensure that the application does not contain information that is false or misleading.
The following must also be provided with the application lodged through eBS:
1. Australian Declaration of Conformity for Class 3 IVDs,
2. TGA-issued Design Examination certificate or Type Examination certificate, as appropriate, for Class 4 IVDs.
If the application is for a Class 3 IVD and a CMDCAS ISO 13485 certificate has been selected to support IVDs in the application, evidence of the Class 3 Canadian Medical Device Licence for the IVDs supported by the CMDCAS ISO 13485 certificate, if an active licence exists, should also be provided.
When lodging an application, the sponsor must certify in accordance with Section 41FD of the Act that:
- 1. The device/s are medical devices;
- 2. The device/s are intended for a specified purpose;
- 3. The device/s are correctly classified according to the medical device classifications;
- 4. The device/s comply with the Essential Principles;
- 5. They have: available sufficient information to substantiate compliance with the Essential Principles, or procedures in place, including a written agreement with the manufacturer of the device/s to ensure that this information can be obtained from the manufacturer within the period required by the TGA;
- 6. An appropriate conformity assessment procedure has been applied to the device/s;
- 7. They have: available sufficient information to substantiate the application of those conformity assessment procedures, or procedures in place, including a written agreement with the manufacturer of the device/ to ensure that this information can be obtained from the manufacturer within the period required by the TGA;
- 8. The device/s comply with every requirement (if any) relating to advertising;
- 9. The device/s do not contain substances that are prohibited imports for the purposes of the Customs Act 1901;
- 10. The information included in or with the application is complete and correct.
For Class 1 IVDs, the most successful applications lodged in eBS will result in an 'automatic' inclusion in the ARTG. This means that there will be no further assessment of the application by the TGA prior to the device being included in the ARTG. However, some devices in applications for Class 1, 2, and 3 IVDs may be subject to a mandatory or non-mandatory application audit which involves checking some or all aspects of the application and certifications. Application audits that are conducted on IVDs are generally limited to the product technical file and are often referred to by the TGA as Technical File Reviews (TFRs).
An inclusion in the ARTG is for a "kind of medical device". This means that an entry in the ARTG may cover a range of products that are of the same kind rather than individual devices. In the case of Class 1, Class 2, Class 3 IVDs, and Class 4 immunohematology reagents (IHRs), one IVD is considered to be of the "same kind" as another IVD, if both devices: have the same legal manufacturer and, have the same sponsor and, are the same classification and have the same GMDN code.
Provided these criteria are met, a single entry in the ARTG may encompass multiple devices. There is no record kept in the ARTG of the product family name, product numbers, or catalog numbers for Class 1, Class 2, or Class 3 IVD medical devices. However, for Class 4 IHRs and Class 1-3 IVDs that have undergone a mandatory technical file review, the names of the individual IVDs covered by an entry will appear in the ARTG. If a sponsor wishes to add a new IVD to an existing entry for a "kind of medical device", and the new IVD is subject to a mandatory technical file review, an application for variation to the ARTG needs to be submitted. For Class 4 IVDs (including Class 4 in-house IVDs) that are not IHRs, a further requirement is added to the definition of the same kind of medical device - they must have the same Unique Product Identifier (UPI).
The UPI is the combination of words, numbers, symbols, or letters assigned by the manufacturer to uniquely identify an individual IVD, or a combination of IVDs which together constitute an IVD closed system. An IVD closed system is a combination of reagents, calibrators, and quality control materials that: share a common intended purpose, and are to be used only in combination with each other as components of a single assay. Closed systems are usually dedicated for use with a single instrument.
The UPI is generally different from the catalog or stock unit identifier assigned to the device and usually, the family name, assay name, and/or test kit name will form a hierarchy in identifying the device. Different manufacturers identify their product lines in different ways such as:
- 1. using family names to identify a range of products that use similar platform technology;
- 2. uniquely identifying each device with an assay name;
- 3. specifying the technology or method an IVD uses;
- 4. specifying the disease marker, a device test; or
- 5. a combination of these approaches. Please note: Different pack sizes, for example, a 100-test kit or a 500-test kit of the same IVD, are not considered to form part of the UPI.
In accordance with section 41FO of the Act, the TGA may impose additional conditions when including the kind of device in the ARTG. These conditions may be imposed to address any specific concerns regarding the manufacture, storage, or disposal of products, keeping records and tracking devices, or any other issues relating to quality, safety, and performance. In accordance with section 41FP of the Act, the TGA may:
- 1. impose new conditions on the kind of device included in the ARTG;
- 2. vary or remove existing conditions. Imposing a new condition, or the variation or removal of an existing condition takes effect:
- 3. if the notice states that the action is necessary to prevent imminent risk of death, serious illness, or serious injury - on the day on which the notice is given to the person;
- 4. in any other case - on the day specified in the notice, not earlier than 20 working days after the notice is given to the sponsor.
In the end, sponsors will be notified by the TGA if their application for inclusion in the ARTG has been successful. The notification will include instructions for printing the Certificate of Inclusion from eBS.
Including IVD medical devices in the ARTG