UDI consultation paper 3: Detailed considerations for implementing the proposed Australian medical device UDI Regulatory Framework

Manufactured overseas, imported into Australia.

As our legal manufacturer is based in the EU, it will be easier for us as Sponsor to facilitate data entry into the AusUDID and ensure harmonisation where possible with the EUDAMED data.

No impact for retail POS (Point of Sale) devices.

There will be no benefits for our products as they are retail POS devices.

As our products are for retail POS, the impact to healthcare users as such hospitals is not relevant.

Within our organisation this will not happen as our legal manufacturer is based in the EU and will not be supplying US compliant labels to Australia and NZ as our products are CE marked.

maybe - as this would align with TGA's regulatory pathway recognising comparable regulators for medical device applications.

As the US currently do, recognising alternative UDIs in the form of EAN-13 barcode for retail POS devices. Additionally, as is the case for EUDAMED, data is not required for higher levels of packaging and this greatly reduces the burden especially as there is no advantage at these levels where they are already traceable through logistics systems.

For retail POS products, identifying the model of device where there is one ARTG entry covering more than one device inclusion by the EAN-13, would provide a fit-for-purpose solution that reduces complexity and does not diminish the principle objectives of UDI.

In the absence of UDI exemptions such as those currently in force in the US, the UDI will need to be made on the point of use labelling for retail POS products where they are supplied in a carton/outer packaging (point of sale packaging), this will provide no benefit to retail POS medical devices and has the potential to impact supply as the manufacturing process does not currently facilitate the addition of the UDI at this level. Human readable batch number and expiry as currently stated should be sufficient.

Retail POS products needs to be considered separately to non-retail medical devices, and in doing so there need to be regulatory changes that take into account these products and that the UDI would be fit for purpose for these. The 2 key principles the Australian UDI system focuses on are not enhanced by the addition of UDI to these types of products, and that the current barcode (EAN-13) is sufficient to meet the key principles intended by UDI in Australia.

Moving EUDAMED implementation timelines will impact EU UDI dates, we would like to recommend that the TGA also allow Australian implementation dates to also be flexible to allow for changes to EUDAMED which reduces dis-harmonisation. Noting the currently mandatory date for upload to EUDAMED is 24 months after it achieves full functionality.

Note in the Borderline Guidance: Devices that are supplied with a medicine to administer a medicine (e.g. syringe), the entire product is regulated as a medicine and do not have to be included in the ARTG. Therefore measuring devices supplied together with a medicine and will never be sold separately should also be exempt from UDI.

We would like to propose that the TGA mirror the general retail exemptions in the US - retail products do not require UDI because there is no benefit, as the UDI codes cannot be scanned at the retail level - imposing UDI on retail products is a burden to industry, for example adding 2D barcode is an additional investment at factory level and increases financial burden on industry.
We have already witnessed costly introduction in EU

As per the US exemptions.

It would be beneficial for the TGA to mirror the general retail exemptions in the US - retail products do not require UDI because there is no benefit, as the UDI codes cannot be scanned at the retail level - imposing UDI on retail products is burdensome to industry and require additional regulatory resources and efforts a well as at factory level, for example, adding 2D barcodes is an additional investment and increases financial burden on industry.

An approach similar to the FDA UDI alternative UDI-A160001 would be hugely beneficial and provide for more rapid identification of retail POS devices while industry establishes processes and procedures needed to comply with UDI requirements and also when accounting for the present state of technology at retail.

We would also like the TGA to consider that if an imported medical device complying to EU regulations (already "UDI'ed") then companies could still voluntarily add this information to the AusUDID to maintain consistency and harmonisation with the EU.

Currently not relevant to our organisation.

Retail POS products should be exempted from the labelling requirements of UDI, as it would provide no benefit for consumers at point of sale and does not improve post market vigilance as the existing barcodes (EAN-13) is sufficient. The barcode should be recognised as an appropriate UDI alternative for these types of medical device and therefore it would be the EAN-13 information entered into the AusUDID.

We recommend the TGA to also consider UDI exemptions for measuring devices (e.g. syringe supplied with a medicine), as the measure device will not be be supplied on its own, as such direct marking with a UDI-DI isn’t required. We understand that this is aligned with the EU position.

There is currently a lack of retail technology to read and interpret UDIs, in the absence of such technology, we recommend the TGA to grant ad-hoc exemptions for devices sold in the retail space until Australia gains a better understanding if there are benefits of UDIs for consumer products that are medical devices (for example, condoms, lubricants, eye drops). The product EANs are presently sufficient to identify medical devices and are well established for post-market safety monitoring and surveillance activities.

We would envisage that as soon as UDI requirements are applicable to 1 product, then that would take precedence over the exemption so there should not be any additional complexities.

In our portfolio this scenario will not occur. If 3 separate UDI records are filed by separate sponsors, how does the TGA foresee the data will be harmonised?

The UDI-PI should be exempt for consumer health products i.e. medical devices for retail POS as it provides no benefits to what is currently already available that adequately identifies the product for post-market monitoring and vigilance.

Direct marking should be exempt for medical devices when supplied together with a medicine (e.g. syringe) as it will never be sold individually and direct marking provides no benefits.

Not relevant for consumer health products for retail POS.

This is not fit for purpose for medical devices sold in retail.

This is not fit for purpose for medical devices sold in retail.

We foresee that discrepancies with GMDN codes would only occur on existing products where the GMDN agency makes older codes obsolete. In this instance the legal manufacturer would be required to update the technical dossiers, which would then flow on to Australian sponsors updating the ARTG with a newly assigned GMDN and in turn trigger an update in the AusUDID.

The correct GMDN should be determined by the legal manufacturer, not sponsor hence our understanding is that GMDN details should be uniform across different countries.

Under the current regulatory framework, as sponsors are responsible for maintaining the regulatory data, local regulatory teams here would take on the additional workload to input and maintain UDI information on the AusUDID in addition to the legal manufacturer's basic UDI data responsibilities.

Further, as our medical devices are predominently consumer products sold in retail and UDI information has no benefits, this is an added burden on the regulatory team.

In order to ensure the correct information will be entered into the AusUDID, a review of our existing products is likely to be carried out.

Not applicable for medical devices sold in retail POS.

There will be no benefit for medical devices sold in retail POS.

There will be no benefit for medical devices sold in retail POS.

There will be no benefit for medical devices sold in retail POS as consumers would not use this information.