Response 552020337

Back to Response listing

Respondent details and general information

Name

EDDY MCFADDEN

Company/organisation

GE HEALTHCARE

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
If there are benefits, what are they?
There will be no reworking of labels to support Australia specific requirements if US and EU labels are acceptable.

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

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

Please select one item
Yes
No

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
Please provide more information below
If Australia is supporting both the US and EU labeling requirements, then yes, both data sets would need to be supported for medical devices with both target markets.

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
If yes, what would that be?
Harmonization with existing US and EU nomenclature and same database

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

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
If yes, please provide more information
Propose to either split Class IIa and Class IIb into 2 phases or Extend Class II implementation to July-2025

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
Consistent with other target markets; harmonized approach

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

3.7. 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
Please provide any other feedback here
Should not be defined by financial reasons; rather intended use and potential risk

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

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
Please provide any feedback here
Aligns with EU and US; traceability back to the manufacturer

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 provide any feedback here
See above; traceability for post market event

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

4.7. 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
Bulk file upload
Web-based (using the online portal)

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

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
Please provide any feedback here
Consistent with US and EU

Question 6 - Fees and charges

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

6.7. 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

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
If yes, please provide more information
Remain aligned with EU or not require a PI per US FDA

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?

Remediate product in the field is challenge

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
If yes, please provide more information
Seems databases are not connected & are dependent on manual updates

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