Response 187317303

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Respondent details and general information

Country

Australia

Which industry component(s) do you represent?

Please select all that apply
Biomedical engineer
Consumer
Consumer organisation
Dental
General practitioner
Government (state or territory)
Government (federal)
Health professional (please specify)
Hospital
Industry organisation or peak body
Issuing Agency
Laboratory professional
Manufacturer (small)
Manufacturer (medium)
Manufacturer (large)
Manufacturer (Australian)
Manufacturer (Australian, export only)
Manufacturer (overseas)
Procurement
Professional body
Registry
Regulator
Regulatory affairs consultant
Researcher or research organisation
Software provider/developer
Sole trader
Specialist
Sponsor
Third party logistics/distributor
Other (please specify)

Are you responding:

Please select one item
As an individual
On behalf of an organisation

Question 1 - If Australia accepts both EU and U.S. compliant labels, what might the impact be?

1.1. Which markets do you supply to or import from?

Please select all that apply
Australia
U.S.
EU

1.2. If Australia is to accept labels and data from both the EU and U.S. what might the impact be for manufacturers/sponsors?

Please select all that apply
There will be benefits
There are no benefits
It will increase the burden

1.3. If Australia is to accept labels and data from both the EU and the U.S. what might the impact be for procurement and supply chain?

Please select all that apply
There will be benefits
There are no benefits
It will increase the burden

1.4. If Australian is to accept labels and data from both the EU and U.S. what might the impact be for healthcare users (such as hospitals)?

Please select all that apply
There will be benefits
There are no benefits
It will increase the burden
If the burden will increase, please provide more information
UDI or medical mattresses and positioning devices will not benefit

1.5. Are there any other benefits we should take into consideration?

Please select one item
Yes
No

1.6. Are there any other disadvantages we should consider?

Please select one item
Yes
No
If yes, what are they?
additional operating costs which will need to be passed on to the consumer with no end user benefit

1.7. Might this create a scenario where there is more than one UDI for the same model of device in Australia?

Please select one item
Yes
No

1.8. Might Australia need to cater for two complete data sets - both EU and U.S.?

Please select one item
Yes
No

Question 2 - What should the phased implementation approach be?

2.1. Do you plan to voluntarily comply with the UDI requirements prior to the mandatory compliance data (for assignment, labelling, and provision of data)?

Please select one item
Yes
No

2.2. If yes, for which devices?

Please select all that apply
All
Class III
Class II
Class I
Class 4 IVD
Class 3 IVD
Class 2 IVD
Class 1 IVD

2.3. Is there anything the TGA could potentially do to accelerate the compliance/provision of data for existing devices (such as using GUDID data for example?)

Please select one item
Yes
No

2.4. For existing devices, what might the complexities be in providing UDIs for each ARTG inclusion if there is more than one device for the inclusion?

mass production of simple low risk Class 1 MD - would not be practical

2.5. Do you envisage any supply related issues in meeting the UDI requirements?

Please select one item
Yes
No

2.6. Are there any other Australian-based regulatory changes we should take into account in our considerations?

Please select one item
Yes
No

2.7. Are there any other international regulatory changes we should take into account in our considerations?

Please select one item
Yes
No

2.8. Is there anything else we should have taken into account for the proposed phased implementation that we have missed?

Please select one item
Yes
No

2.9. Do you have any other thoughts or suggestions on the implementation?

If yes, please provide them here
nil

Question 3 - Scope and exemptions

3.1. Should Class I medical devices be in scope for UDI?

Please select one item
In scope
Out of scope
Voluntary
Please provide more information
mass production of simple low risk Class 1 MD that are provided non-sterile and have no measuring capacity would not be suited for this system. Totally understand with implantable , sterile devices and other high risk MDs

3.2. Should Class I IVDs be in scope for UDI?

Please select one item
In scope
Out of scope
Voluntary

3.3. Should Australia adopt a similar approach to the U.S. for consumer health products (that is, the universal product code becomes the primary identifier and data is not included in the UDI database)?

Please select one item
Yes
No

3.4. Should Australia adopt a similar approach to the EU in grouping Class I devices (such as the Master UDI-DI)?

Please select one item
Yes
No

3.5. Are there any additional devices that could be exempt?

Please select one item
Yes
No
If yes, which devices and why?
medical mattresses, positioning devices, wheel chair pads, heel cushions

3.6. Are there any devices we have proposed to be exempt that should not be?

Please select one item
Yes
No

3.7. Should there be special considerations for packages (which include medical devices) supplied free of charge to homeless or disadvantaged people? Should these packages as a whole be exempt from UDI requirements?

Please select one item
Yes
No

3.8. Should the Australian system include ad-hoc requirements for exemptions (as the U.S. does)?

Please select one item
Yes
No

3.9. Are there complexities we should consider in linking ARTG ID to UDIs if some devices in a single ARTG inclusion are exempt from UDI requirements, and others are not?

Please select one item
Yes
No

Question 4 - Who should provide and maintain the data where there are multiple sponsors for a device?

4.1. Should there be one UDI record per combination of model of device and sponsor? That is, if one model of device is supplied by three sponsors should there be three UDI records for the same device, one per sponsor?

Please select one item
Yes
No

4.2. Where a model of device is supplied by more than one sponsor, should there be a single UDI record and single 'owner' of all device (i.e. non-sponsor) data in the AusUDID?

Please select one item
Yes
No

4.3. If yes, who should it be?

Please select one item
Manufacturer
First authorised sponsor
Other

4.4. Should the labeller be responsible for all the data, including the sponsor details?

Please select one item
Yes
No

4.5. Should the TGA limit access to specific data elements depending on role? For example, should there be a 'labeller' role which can access all the data, but the 'sponsor' role can only add/amend sponsor details?

Please select one item
Yes
No

4.6. Are there other approaches the TGA should consider?

Please select one item
Yes
No

4.7. Might we need to allow for a scenario where a device that is supplied by multiple sponsors may have to allow for different commercial distribution statuses? That is, if two sponsors supply one model of device, could it be in commercial distribution with one but not the other?

Please select one item
Yes
No

Question 5 - Providing and maintaining data over the full life of the device

5.1. How many models of devices do you expect to provide data for (existing devices)?

Please select one item
<10
10-50
51-100
>100

5.2. Which method do you plan to use to provide UDI data to the TGA? Please rank (1=most preferred, 4=least preferred)

Please rank these from 1 to 4
Bulk - Machine to Machine (e.g. HL7 SPL)
1
Bulk – National Product Catalogue
2
Bulk file upload
4
Web-based (using the online portal)
3

5.3. Do you foresee any challenges relating to the proposed triggers?

Please select one item
Yes
No

5.4. Are there any data elements we have missed?

Please select one item
Yes
No

5.5. Are there any data elements we have included that are not required?

Please select one item
Yes
No

5.6. Are there any data elements we should not require for IVDs?

Please select one item
Yes
No

5.7. Do you envisage you will make any changes to the ARTG as a result of the introduction of UDI?

Please select one item
Yes
No

5.8. Do you envisage any difficulties in keeping the data in the ARTG, Prostheses List and AusUDID aligned and current?

Please select one item
Yes
No

5.9. Do you think the TGA should require that the GMDN code be kept aligned with the GMDN Agency codeset while the device is in commercial supply?

Please select one item
Yes
No

5.10. Do you think there should be a one-to-one relationship between the catalogue number and the UDI? That is, if the catalogue number changes a new UDI-DI is required and vice versa?

Please select one item
Yes
No

5.11. Should the TGA consider additional fields for MRI safety status?

Please select one item
Yes
No

5.12. Please provide any other data feedback here

nil

Question 6 - Fees and charges

6.1. Do you have any feedback on what we should take into account when developing the UDI fees and charges model? In particular, considerations around current and correct data, and understanding that device data will change over time?

Please select one item
Yes
No

6.2. Should the TGA consider moving to a fee structure which takes into consideration the number of changes to the UDI data over time?

Please select one item
Yes
No

6.3. Should the TGA consider moving to an annual charge for UDI based on the number of UDI records?

Please select one item
Yes
No

6.4. Is there anything else the TGA should consider in relation to determining the annual charge?

type, criticality and complexity of the device v simple class 1

6.5. What might make it easier for labellers to keep the data up to date in relation to fees and charges?

nil

6.6. What might the TGA consider in relation to fees and charges for machine to machine, NPC, or bulk transactions?

nil

6.7. Should the TGA include the cost of regular reviews and updates of the AusUDID to ensure it remains fit for purpose over time?

Please select one item
Yes
No

6.8. Please provide any other fees and charges feedback

nil

Question 7 - UDI labelling and supporting documentation

7.1. Do you have any feedback on the composition of the UDI-PI for specific devices or scenarios?

Please select one item
Yes
No

7.2. Do you have any feedback on direct marking requirements? Are there considerations or scenarios we have not taken into account?

Please select one item
Yes
No

7.3. Are there any considerations we should take into account for Patient Implant Cards?

Please select one item
Yes
No

7.4. What would be your preferred method of providing Patient Information Leaflets for your devices?

Please select one item
As a PDF document
As a link to an external website where the PIL is hosted and publicly available for download
Both a PDF copy and a link to an external website
Other

7.5. Do you foresee any issues or complications if the PIL repository was developed as part of the AusUDID database or the ARTG Search database on the TGA website?

Please select one item
Yes
No

7.6. Are there complexities we should take into account if PILs are required for multiple devices in an ARTG inclusion?

Please select one item
Yes
No

7.7. Do you think there is a better platform other than the AusUDID or the ARTG Search, through which a PIL repository could be delivered?

Please select one item
Yes
No

7.8. How might hospitals capture UDIs at the point of care for small implantable devices that cannot be direct marked and are unpackaged? Should labellers/kit providers provide additional information?

Please select all that apply
Labellers or kit suppliers should provide additional information (say via a checklist or kit packing list)
Labellers or kit suppliers should provide stickers
Other

Question 8 - Global Medical Device Nomenclature

8.1. Can you foresee issues in having GMDN at kind of device level in the ARTG and model of device level in AusUDID?

Please select one item
Yes
No

8.2. If the TGA was to require that the GMDN Term Name in the AusUDID is to remain aligned with the GMDN Agency code set over the life of the device, what might the impact be for manufacturers and sponsors?

nil

8.3. With the introduction of UDI in multiple countries, do you already have challenges in maintaining GMDN for your devices?

Please select one item
Yes
No

8.4. For IVDs, do you foresee any issues in requiring collective terms (CT) for the ARTG inclusion and GMDN Term Name in AusUDID?

Please select one item
Yes
No

Question 9 - Regulatory burden

9.1. Given the details provided in this paper, do you envisage that the introduction of the Australian UDI will increase the burden on manufacturers or sponsors over and above complying with other countries requirements?

Please select one item
Yes
No

9.2. If yes, what might those be?

Please select all that apply
Additional cost
Administrative overheads
Data management overheads
Other

9.3. Do you see the implementation of the Australian UDI requirements as a point at which you might review the products you supply into Australia?

Please select one item
Yes
No

Question 10 - Adoption and use

10.1. Is it possible that there will be challenges at the point of care in working out which UDI-DI to assign to the patient? For example, it could be a Direct Marked DI, Unit of Use DI or Primary DI.

Please select one item
Yes
No
If yes, please provide more information
medical mattresses, positioning devices, wheelchair cushions and heel rests would not benefit

10.2. Would there be benefit in the AusUDID including a point of care DI "POC-DI" in the AusUDID?

Please select one item
Yes
No

10.3. Should the same apply for UDIs used for billing purposes?

Please select one item
Yes
No

10.4. Are there any specific considerations we should take into account from the data users' perspective?

Please select one item
Yes
No

Question 11 - Any other feedback?

We would appreciate you providing any other feedback that you might have

nil