Reforms in the Medical Devices Regulatory Framework: Summary Table of Submissions



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Proposal 3

Proposal 3(i)

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Respondent

Response


1

3M Australia Pty Ltd

Do not support because:

  • Itemising will not enhance the consumer or patient’s ability to identify registered products as often it is the health professional using the product;

  • Dental and orthodontic products maintenance of products by item number is a huge undertaking –several hundred items per same kind of device- and benefit is questionable;

  • Suggest listing of brand names as an alternative, similar to prescription and OTC;

  • Transition period is too short; and

  • Will result in a significant ongoing cost as the sponsor would be paying for each new item added.

2

Abbott Australasia P/L (Diagnostics Division)

Recognises the limitations of the current regulatory system. Suggests that inclusion of model numbers and variants for IVD devices be optional. For low and medium risk devices not requiring assessment recommends that sponsors be able to update/vary their entries to add new models as an auto update to the ARTG through eBS with no pre market oversight or fee increase. Higher risk devices to continue to require an assessment including new products. Do not support any proposal for further IVD devices to undergo an assessment to allow an addition of a new/product or model to an existing inclusion on the ARTG.

Are willing to supply the TGA with the Document of Conformity Assessment (DoC) but do not support its inclusion on the TGA website as a public document as the DoC:



  • Could contain confidential information;

  • Would mean little to the general public; and

  • May take on a variety of forms from manufacturers, making it difficult to interpret the information.

Suggest that the only information of value to stakeholders would be the names of the medical devices which could be provided as a simple table under the ARTG inclusion.

3

Advocate for the Consumer, Cosmetic, Hygiene and Specialty Products Industry (ACCORD)

Tentatively accept provided that the assessment requirement is removed for devices that are Class IIb and above. Are not aware of any failures in the system to warrant their increased assessment.

Tentatively supports creating a list of all medical devices that are included under an ARTG entry as long as there is no fee and the TGA eBS system can cope. Will address TGA’s need for increased post market monitoring.



4

Advanced Medical Technology Association (AdvaMed)

Supports Medical Technology Association of Australia (MTAA) position.

5

Amgen Australia

Should apply to Class III and above. The regulatory burden and ARTG burden to list different models doesn’t match the benefit for low risk items.

6

AMPAC Dental Pty Ltd

Would place an additional burden and result in additional costs. Would like TGA to define the specifics of a model and when sponsors must notify the TGA of changes.

7

ANZ dental

Will result in a large one off cost and increased ongoing costs. Transition time is too short. Suggests listing the device name on the ARTG to avoid increased compliance costs.

8

AusBiotech Ltd

Supports this proposal in principle. Notes that industry requires clarity on requirements, definition of models, and individual devices. Concerned that this could cause huge increases in item listings and resultant increases in administrative burdens and increased regulatory costs. The requirement for an application for variation for each subsequent addition on new devices/models could result in extensive lists of products that may make it harder for healthcare professionals and the public to access relevant information.

9

Australian Dental Association Inc (ADA)

Concurs with the ADIA. Preferred alternative to list the product name on the ARTG entry for a medical device. Timeframe is too tight. Propose two years.

10

Australian Dental Industry Association Inc (ADIA)

Not supported in its current form as it will add significantly to the regulatory compliance costs and hence consumers. Ambiguity in how the TGA will require sponsors to itemise the devices, by model number, model or trade name. Advice to the ADIA from the dental industry arising from this proposal would require fifty new model applications each week impacting on processing times. Recommends a 3 year implementation. Proposal is inconsistent with the OECD Guiding Principles for Regulatory Quality and Performance. It is expected that the dental industry will be required to provide nearly 30000 new data items over the twelve month period with an estimated increased compliance cost of 1-1.5% to industry over the twelve months. With 4000 entries requiring amendment annually and an ongoing regulatory compliance cost to industry of 0.75%. Recommends trade name be used.- Define new model. Update eBS portal to allow sponsors to update on a fee free basis. Update ARTG website to allow search by trade name and 24 months be given for implementation.

11

Australian Health Insurance Association (AHIA)

Support- The National Product Catalogue should be used to capture device details across industry.

12

Australian Orthapaedic Associaiton Limited

Agrees with the approach as they are outlined in the proposal.

13

Baxter Healthcare Pty Limited

Recommends that this part be adopted. Sponsors to provide the TGA with a list of registered devices identified by model number, product catalogue number or trade name under each ARTG entry.

14

BIOTRONIK Australia Pty Ltd

Understands and supports the proposal, however rejects any proposal to place the ARTG number on the label on the product as it would require country specific labelling which is not feasible.

15

BORG Dental (Bordent Pty Ltd)

Do not support. Increased regulatory burden due to the increased size of applications and required IT and maintenance. Increase time to market and discourage companies and suppliers from introducing updated devices into Australia.

16

Bosco Medical Australia

Suggest that the transition period be 24 months and that no fees be charged for the variance.

17

Bourke Dental Supplies

Do not support. Increased applications required and increased burden on IT requirements.

18

CareFusion Australia & New Zealand

This proposal is confusing as it only applies to Class IIb or above. Sponsors will simply include one or two models at the first application, then add all the rest of the models later to avoid unnecessary scrutiny by the TGA.

19

Carl Zeiss Vision

No comment.

20

ConMed Corporation

This proposal goes further than the Recommendation 8 of the HTA review as it includes all devices not just higher risk devices. Inclusion and variation costs could deny access to new models. The list will allow ready access by organisations to their competitors’ full listing of approved devices. Propose to allow sponsors to update within a defined period of time a list of models in a sponsor/TGA restricted area of eBS ARTG. Define a list of variants that assessment would not be required and make fees nominal for a variation if any especially if sponsors upload the material themselves.

21

Consumers Health Forum of Australia (CHF)

Support the proposal to itemise the devices and various models to allow better tracking for safety. Consumers wish to see greater harmonisation between Australia and international processes. Suggests that TGA undergoes a program of information sharing with bodies recognised under the MRA and remains up to date with current international trends.

22

Cosmetic Physicians Society of Australasia Inc

No comment.

23

Critical Dental Pty Limited

This will result in a substantial one off cost and ongoing costs. Prefers to list the product names of devices in the ARTG entry rather than the model name allowing more model updates that do not considerably alter the devices function to be updated at minimal cost. Also support a 2 year time frame.

24

Dentalife Pty Ltd

Strongly support. Will increase transparency of the TGA regulatory approval for medical devices and enhance identification to legally supplied approved medical devices. Will also give healthcare providers and consumers’ confidence in the use of the product.

25

Dentaurum Australia Pty Limited

Will result in a very large initial one off cost and significant ongoing costs.

26

Dentsply (Australia) Pty Ltd

Will lead to increased regulatory burden for lower risk devices where there are large numbers of devices. No detail provided in the paper of a clear demand for this information from either oral healthcare practitioners or consumers. Do generally agree that the ARTG could be improved by linking an individual entry with models of a particular device. This needs to be carefully balanced against introducing an excessive regulatory regime which delays new product approvals or prohibits new products. The TGA must clearly define which changes would be considered significant. An alternative would be to list the product name on the ARTG with the allowance made for a number of names to be included under a single ARTG entry where all are the same kind of device. Variations could be automatically added and subject to audit as Class I is now and based on level of risk. A two year timeframe is more realistic.

27

Department of Innovation, Industry, Science and Research

Not enough information to fully assess the proposal. Broad industry adverse reaction to the implications of an Australian specific requirement on individual medical devices.

28

Device Technologies Australia Pty Ltd

Cannot support as there is insufficient detail to determine the impact and feasibility. Propose: Class I non-sterile, non measuring devices are excluded; identification is through a fee free notification system for all classes; removal or amendment of model or trade names should not incur a fee or undergo review; information is automatically accepted: post-market audits used to review content; identification by model or trade name is determined by the sponsor; flexibility is employed to accommodate the vast range of product types and naming conventions; and the TGA develop with industry a resourcing plan to assess the number of expected applications. Also proposes a significant fee reduction and proposes TGA implement faster processing times to vary inclusions.

29

Draeger Medical Australia Pty Ltd

In principle support. Should not require a complete new application when new models become available. Any cost should be covered by the annual licence fee. Propose that the initial entry be amended/varied and a manufacturer declaration of conformity for the new model be attached as evidence of the required conformity assessment. Recommend a 3 month window before the 12 month timeframe is introduced.

30

Dynek Pty Ltd

Such a list would exceed 9000 models and would do little to achieve the TGA’s aims. If the TGA charges the cost would be prohibitive. Require clarification on the extent of this proposal.

31

EBR Regulatory Affairs Consultants

Why do we need to do this? How does having this information add to the safety or quality of the device? If accepted there should be no fees associated with it. 12 month transition is too short.

32

Erskine Dental

Do not support in its current form. Will result in a large one off cost and increased ongoing costs.

33

Essology Pty Ltd

Concerned at the practical implications of the consumer/patient benefit. Also questions how reusable devices will be treated?

34

Fisher & Paykel Healthcare Limited

Agree with the general principle which is consistent with other regulators. Would like further clarification of the costs involved. The addition of one model number to an already approved ARTG number should not attract the same application fee as a new submission, particularly if the device is Class IIb or below. Also would like a definition of the assessment that an application to add a model number to Class IIb ARTG entry would undergo. Define model number and trade name. Preference would be to have model number as the minimum requirement but with an option of also having trade name listed. Ensure that a process is included for removing products from the ARTG entry.

35

GE Health Care Australia Pty Ltd

Would require a 2 year transition period. Require further clarification of the fee to be charged by the TGA to vary the inclusion after the transition period.

36

GlaxoSmithKline Australia Pty Ltd

Fully supports. The proposed transition period of 12 months at no cost seems reasonable. However cost should be minimal to lodge a variation application to register a new model or trade name after the transition period. It should reflect the amount of data submitted by sponsors and the time taken for TGA to assess it.

37

Gunz Dental Pty Ltd

Supports this position. Other than complete identification of every device line item which substantially alters the existing regulatory arrangements for the business. An impossible task to identify every line item of device that currently sits under an ARTG entry. For 35000 items it will require substantial IT burden and cost to maintain. To be subjected to the requirement for variation and not knowing how much this will cost and if TGA audit is also required will increase time to market. This will actively discourage companies and suppliers from introducing updated devices. Large one off cost and significant ongoing costs. Best practice will be reduced along with end users choice.

38

Healthlinks.net Pty Ltd

No comment.

39

Henry Schein Halas

Not supported in its current form as it will add significantly to the regulatory compliance costs and hence cost to consumers. Ambiguity in how the TGA will require sponsors to itemise the devices, by model number, model or trade name. Advice to the ADIA from the dental industry arising from this proposal would require fifty new model applications each week impacting on processing times. Recommends a 3 year implementation. Proposal is inconsistent with the OECD Guiding Principles for Regulatory Quality and Performance. It is expected that the dental industry will be required to provide nearly 30000 new data items over the twelve month period with an estimated increased compliance cost of 1-1.5% to industry over the twelve months. With 4000 entries requiring amendment annually and an ongoing regulatory compliance cost to industry of 0.75%. Recommends trade name be used.- Define new model. Update eBS portal to allow sponsors to update on a fee free basis. Update ARTG website to allow search by trade name and 24 months be given for implementation. Suggest using the declaration of conformity and keep entries at the GMDN level. Could link the declaration to the public domain.

40

Independent Rehabilitation Suppliers Association (IRSA)

Will result in significantly increased costs, reduced competition, less choice for consumers with disabilities and potentially drive individuals towards unregulated importation. Not consistent with global harmonisation, does not see any safety or quality benefits. It may be impossible to undertake for many sponsors as they source from multiple manufacturers.

41

Integra Neurosciences Pty Ltd

Require a longer implementation period. Estimating stock depletion is not easy with devices as many do not have an expiration date.

42

Invacare Australia Pty Ltd

This will not enhance the identification of approved devices. If implemented no fees should be charged for future variations to include additional products. Would require a 2 year transition period.

43

IVD Australia

Questions the cost benefit and has concerns at the cost to sponsors. Recommends that: IVD medical devices be included at the family level for Class 1 and 2 IVDs; notification of changes to product details as proposed be available through the eBS at no charge and only required annually; variation of inclusion only be used for substantial changes; and the transition period be 3 years.

44

Ivoclar Vivadent Pty Ltd

Will cost a lot of time and energy. IT costs will be substantial at the outset and ongoing.

45

Johnson & Johnson Medical Pty Ltd

Support. Provided the system can be electronically updated by the manufacturer at no cost with a notification system.

46

Johnson & Johnson Pacific and Vision Care Australia

Supports. Need clarity of the definition of an individual device, clarity on the process of how products will be included on the ARTG. Suggest the system as is used for other therapeutic goods such as tampons? Proposes a fee free notification system or a minimum fee to cover administration only.

47

Magic Mobility (Red Milawa Pty Ltd)

Propose to itemise their wheelchairs at the platform level otherwise they would be put out of business. Each wheelchair they manufacture has a serial number already on it. Costs would be prohibitive. No fees should be charged. 12 months is too short for the transition period. Commented that there was one token consultation in Melbourne and they were not invited.

48

MAQUET Australia Pty Ltd

An alternative could be greater application of the penalties already available to the TGA when non-compliance is identified. Should this go ahead suggest that there is no fee to vary inclusions?

49

Max Boccardo Associates

Not supported. Require further validation of concerns.

50

Medical Technology Association of Australia (MTAA)

Recommends that:

  • TGA provide for identification of medical devices on the ARTG through a fee free notification system, supplemented by post market audit; and

  • The transition period be extended for two years.

51

Medtronic Australasia Pty Ltd

Supports and proposes a fee free notification system through eBS.

52

Multigate Medical Products Pty Ltd

Will have an impact on many of the different procedure packs that are produced for specific hospitals or surgeons. Will impose an inappropriate burden on both the company and the TGA for the level of safety and performance.

53

National Serological Reference Laboratory (NRL)

No comment.

54

Nobel Biocare Australia Pty Ltd

Would like TGA to define the specifics of a model and what constitutes a specific change. Propose a requirement for a model name (but not a model number) with TGA modification needed only when a significant change takes place. Will lead to a large one off cost and significant ongoing costs. Recommend a 2-3 year transition time.

55

Novo Nordisk Pharmaceuticals Pty Ltd

Support but should not require TGA approval. Would increase level of regulatory burden to be greater than the risk.

56

NuVasive Australia & NZ Pty Ltd

Does not support. Result in significant additional burdens and it is unclear how the process will improve TGA approval confirmation. Concerned that additional assessment will be needed each time a new product is added, with additional fees and longer approval times. This could cause delays in the availability of new models.

57

Otto Bock Australia Pty Ltd

Proposal looks like revenue raising. Is this the first step in getting an ARTG for all devices? How does having this additional information add to the safety and quality of a device? Changing the definition will not enhance the identification of approved devices. If accepted then should be fee free. 12 months is too short. Suggest TGA use other methods than further regulating the industry to deter people from manipulating the process.

58

Paragon Therapeutic Technologies Pty Ltd (PTT)

How does having this additional information add to the safety and quality of a device? Only allows notification without any prior validation before appearing on the ARTG. The maintenance cost will increase from between $20 000 to $180 000. Should be no fee associated. Does not support the proposal to submit variations for additional products after the transition. New updated devices could amount to 200-500 variations per week leading to unnecessary delays due to the increased processing times. Recommend to use a fee free notification process using the online eBusiness system. Use the ARTG to identify all additions and undertake reviews according to the classification and the GMDN code similar to the Class I process.

59

Pfizer Australia Pty Ltd

Requires further information regarding on what basis applications will be assessed and approved and whether significant technical data would be needed. Also seeks clarification whether lower class devices would be included. Proposal would have significant impact on the cost of medical devices, especially lower risk devices. Suggest the use of a fee free notification system for lower risk devices. The number of new listings on the ARTG may slow the website down. Itemisation of devices is already detailed on the Australian Declarations of Conformity and this could be supplied to the TGA via notification without a new application being required. Costs will be incurred to maintain numerous entries on the ARTG when there was previously only one. Would like clarification on the charges associated with multiple variations.

60

Queensland Health- Clinical and Statewide Services Division

Welcome improvements to the way in which medical devices will be included in the ARTG.

61

Queensland Health– Chief Health Officer

Support as experience has shown that some ARTG certificates have limited product information.

62

Queensland Health– Centre for Healthcare Improvement

Fully support. The model field should be searchable to allow improved search capability of the ARTG.

63

Resmed

Support for low and medium risk devices not requiring assessment. Sponsors should be able to update or vary their entries to add new models as an automatic update of the ARTG. There should be no pre-market oversight or fees associated. Higher risk devices requiring an application audit should continue to require an assessment. Opposes any requirement for Class IIb (other than Class IIb implantable) devices to undergo an assessment to allow addition of a new model. Will add significantly to the regulatory overhead and is not justified by the level of risk.

64

Royal Australasian College of Physicians (RACP)

Supports the use of post marketing safety and surveillance for medical devices.

65

RTI Biologics Inc

Recommend that the costs associated with “assessment of subsequent variations” be proportioned according to the level of assessment required.

66

Seating Dynamics Australia Pty Ltd

Changing the definition will not enhance the identification of approved devices. How does having the additional information add to the safety or quality of the device? TGA should prosecute those manipulating the system and publish outcomes. If accepted then no fees should be charged. 12 month transition is too short considering the amount of information required.

67

Smith & Nephew Pty Ltd

Supports provided it is a fee free notification process. Does not adequately specify the level at which individual products are to be entered onto the ARTG. Specificity of product detail to be entered on the ARTG should not exceed that which is reasonably required by a user to identify a product.

68

Stryker Australia

Increases ongoing administrative costs if additional assessment is added. Recommend implementing a fee free notification process managed via eBS.

69

STS Health

Overall support, however would like a description of what constitutes new model and caution on setting the bar too high and causing delays and frustration. Concerned at the increase in compliance costs will result in large one off charges and significant ongoing costs.

70

N/A

N/A

71

The Pharmacy Guild of Australia

Supports to improve the useability of the ARTG. Would like improved search functions for the ARTG. Would also like to see distinct categories with the ARTG Public summary standardised. Currently this is inconsistent. “Active ingredient” is a search function for devices which is not applicable. Believes maintaining entries should be a shared responsibility of industry and the TGA, to monitor.

72

TrioDent Ltd

Need definition of what a model is and what changes constitute a new model. Results in a very large one off cost and significant ongoing costs.

73

WelchAllyn

Recommend that: Class I products are still automatically included on the ARTG; any additional products included in that registration should be also automatically included within a 24 hour turn around using a variation process; and Class I products continue under the current Post-market vigilance and monitoring program.

For Class I measure, Class IIa, Class IIb: continue using the method for application of manufacturers evidence with a 2 week turnaround with the relevant certification and documentation; require the relevant product codes for all device applications with no change in application fee; and have a variation submission process for adding additional part numbers to products that have been issued the relevant conformity assessment documentation at a minimal fee.



74

Whiteley Corporation Pty Ltd

Currently proposal is unclear of the process the TGA will use to include kinds of device. Sponsor should submit a notice of intention to market the product onto the eBS website without a full assessment by the TGA. This will allow TGA to know all of the products under an ARTG number but also reduce any regulatory costs or impacts on time to market.

75

William Green Pty Ltd

Need definition of what a model is and what changes constitute a new model. Recommend TGA consult with industry on what constitutes a significant change. Transition time should be 3 years. Result in substantial one off cost and significant ongoing costs.

76

Zimmer Pty Ltd

Support. Propose that TGA accept the identification for existing Class III devices that have Design Examination Certificates issued by accepted Notified Bodies. For new Class III applications the sponsor should make the identification in the application. For Class IIb the sponsor should make the identification for both new and existing applications.

77

Zoono Solutions Pty Ltd

Propose to either use GTIN numbers or align the eBS with the National Product Catalogue.
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