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



Download 0.7 Mb.
Page9/9
Date conversion09.12.2016
Size0.7 Mb.
1   2   3   4   5   6   7   8   9

Proposal 4

#

Respondent

Response


1

3M Australia Pty Ltd

Supports publication of higher risk devices such as Class III and AIMD- not lower classes. Does not support publication of information relating to rejected applications. This process does not apply to prescription and OTC medicines and information would be considered to be corporate and of no benefit to consumers.

2

Abbott Australasia P/L (Diagnostics Division)

Does not support. Not clear how this would benefit end users.

It is a duplication of information on the TGA website.

This would act as a default assessment and approval process for each new model and device not currently requiring mandatory pre-market assessment.

Publication of safety and performance data only on assessed product is of little benefit for other devices under the ‘kind of device’ and singles out medical devices.



3

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

Does not support particularly for lower classes. Believe the TGA should consider the types of devices that are likely to deliver benefits. Will lead to an increase in costs to industry. Do not support the publication of rejected applications. Do not see the value and believe it has the potential to confuse and undermine consumer confidence in individual sponsors unnecessarily as the product would not be available anyway.

4

Advanced Medical Technology Association (AdvaMed)

Supports Medical Technology Association of Australia (MTAA) position.

5

Amgen Australia

Only for high risk devices. TGA should be the author and could include: submission evidence; instructions for use; risk/benefit; and TGA’s overall assessment. All rejected applications should be published as a source of information to guide new device applications.

6

AMPAC Dental Pty Ltd

No comment.

7

ANZ dental

No comment.

8

AusBiotech Ltd

Supports the principle. Raises further issues: who maintains the data: controls over the level of appropriate information consistent with the user profile; compliance with advertising standards; consideration about whether to publish information on rejected applications and whether this applies to all devices or higher risk devices only; and disclosure of commercially sensitive information and measures available to protect sensitive information?

9

Australian Dental Association Inc (ADA)

Supports for higher risk devices not lower risk devices. Will greatly increase costs as most of the material is produced overseas and will require review, editing, and legal checks.

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. Further the TGA has not demonstrated that it is in the public interest to publish this information. ADIA does support publication of information for Class III and AIMDs. Doesn’t support publication of any rejected applications.

11

Australian Health Insurance Association (AHIA)

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

12

Australian Orthopaedic Association Limited

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

13

Baxter Healthcare Pty Limited

Supports for higher risk devices Class IIb, III and AIMD only.

14

BIOTRONIK AUSTRALIA PTY LTD Australia Pty Ltd

No comment.

15

BORG Dental (Bordent Pty Ltd)

Do not support. Is impractical as the medical model is not available for this sector. The dental professional has access to this data already. Leads to an increased requirement for information and duplication of current information. Questions who is responsible for maintaining the information.

16

Bosco Medical Australia

Do not see the requirement. Information is already freely available from the sponsor. Questions who would bear the cost of uploading the information and keeping it up to date? Information could be more regularly updated in house.

17

Bourke Dental Supplies

Do not support. Impractical to implement. No model for CMI or PMIs for this industry sector. Already have access to MSDS data, explanatory notes, web access and product information on line and through their professional body the Australian Dental Association.

18

CareFusion Australia & New Zealand

This proposal is of good intent. Difficult to keep the TGA website up to date. Confuse users as there will be two sources of information. Only credible source should be the manufacturer either on their website or provided to users directly. Publishing rejected applications does not add value.

19

Carl Zeiss Vision

No comment.

20

ConMed Corporation

No evidence that the existing information is deficient. Delays will be experienced if TGA needs to agree material. Concerned that commercially sensitive information would be publically available. May cause overseas manufacturers to stop supply in Australia or at least until available in other markets. Suggest limiting the required information to existing labelling and continue to use FOI provisions.

21

Consumers Health Forum of Australia (CHF)

Supports the publishing of:

  • General announcements of device approvals;

  • Copies of approval letters;

  • Summary of safety and effectiveness data;

  • Instructions for use;

  • Consumer instructions; and

  • Links to general resource information, such as information from the National Institute of Health (NIH) information or clinical papers.

22

Cosmetic Physicians Society of Australasia Inc

No comment.

23

Critical Dental Pty Limited

No comment.

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.

25

Dentaurum Australia Pty Limited

No comment.

26

Dentsply (Australia) Pty Ltd

Most of the dental services that Dentsply (Australia) Pty Ltd supply are manufactured overseas so this would increase compliance costs for low risk devices. If the TGA publishes rejected applications information it would need to be limited to reasons of safety and/or efficacy similar to medicines. Publication of rejected lower risk devices for incorrect GMDN code or apparent GMDN code definition and intended purpose of a device would not be in the public interest.

27

Department of Innovation, Industry, Science and Research

Not enough information to fully assess the proposal. Suggest that this could be done by notification only.

28

Device Technologies Australia Pty Ltd

Does not support. Recommends: the need and specific benefits be clearly determined; this proposal should not be mandatory; and further discussion with stakeholders should occur. Agrees that information about assessments be published but not including the device literature and that TGA publish information about the decisions made during the assessment process but not rejected applications.

29

Draeger Medical Australia Pty Ltd

Do not see any increased value in doing this. Information is already supplied in the accompanying instructions for use. Users only interested in knowing if the device is TGA approved.

30

Dynek Pty Ltd

The proposal bears no relationship with Recommendation 8 of the HTA review. What is unclear is who will cover the time and expense in preparing, updating and validating these documents.

31

EBR Regulatory Affairs Consultants

It should be done at the expense of TGA.

32

ErskineDental

Support for higher risk devices but not lower risk devices. Increased costs would outweigh the need.

33

Essology Pty Ltd

No comment.

34

Fisher & Paykel Healthcare Limited

Unclear how this will benefit stakeholders and reject. Increased costs to manufacturers, distributors and sponsors. The value of publishing rejected applications is minor but potentially harmful to the manufacturer. Minor reasons such as incorrect GMDN alignment are not helpful. There is commercial sensitivity as it indicates an intention to a competitor to bring a new product to market.

35

GE Health Care Australia Pty Ltd

Supports. However cautions that publishing rejected applications may contain commercially sensitive material and may cause a manufacturer to reconsider submission. This may not be relevant to the consumer and healthcare professional.

36

GlaxoSmithKline Australia Pty Ltd

Does not support for all medical devices. Should be risk based. Higher risk devices only such as Class III and AIMDs. Lower risk devices should be exempted.

37

Gunz Dental Pty Ltd

Totally impractical. Dental professionals already have access to significant MSDS data, explanatory notes, web access and product information and supported by the professional body Australian Dental Association. Leads to an increase and duplication in information. Who is responsible for maintaining and ensuring its accuracy? No public interest on publishing rejected applications.

38

Healthlinks.net Pty Ltd

Support for all medical devices to be aligned as much as practical with that required for medicines. Suggest establishing usability guidelines for devices. Also suggests the distribution of the information expanded as much as possible. All information should remain copyright of the respective sponsor and all accuracy and currency of the information remain the sponsors responsibility.

39

Henry Schein Halas

Not supported in its current form as it will add significantly to the regulatory compliance costs and hence consumers. Further the TGA has not demonstrated that it is in the public interest to publish this information. ADIA does support publication of information for Class III and AIMDs. Doesn’t support publication of any rejected applications.

40

Independent Rehabilitation Suppliers Association (IRSA)

No comment.

41

Integra Neurosciences Pty Ltd

No comment.

42

Invacare Australia Pty Ltd

No comment.

43

IVD Australia

Not supported. Require information on what material is required, how it is initially to be entered and who will update it. Recommends that only successful applications that have undergone a mandatory application audit should be published and that rejected applications not be reported.

Suggests duplication of already existing materials.



44

Ivoclar Vivadent Pty Ltd

No comment.

45

Johnson & Johnson Medical Pty Ltd

Supports for higher risk devices only (class III and AIMDs) and to devices where the end user is a patient. Information is already provided via company websites and booklets and recommends that accessibility be enhanced through collaboration with industry associations such as the Medical Technology Association of Australia (MTAA). Do not support publication of information which is intended solely for the user (health care professional) and may contain proprietary information. Do not support the publication of rejected applications due to commercial in confidence reasons. Recommend that TGA publish a percentage of applications rejected versus those approved as a measure of effectiveness.

46

Johnson & Johnson Pacific and Vision Care Australia

Should be risk based. Higher risk devices only such as Class III and AIMDs. Lower risk devices should be exempted as information that would be published would not have been validated.

47

Magic Mobility (Red Milawa Pty Ltd)

No comment.

48

MAQUET Australia Pty Ltd

Patient instructions, IFU’s, user guides, references to clinical papers are typically available on the manufacturer’s website. Would require significant commitment to keep up to date.

49

Max Boccardo Associates

Support for Class III devices and higher but not lower.

50

Medical Technology Association of Australia (MTAA)

Recommends that the publication of device information on TGA’s website be trialled on a small scale, voluntary pilot with implementation on a broader scale only after positive assessment of the pilot including consumer support.

51

Medtronic Australasia Pty Ltd

Proposes that this be subject of a separate consultation process to examine the real need being addressed, the kinds of information already available and the medium to be used to supply the information.

52

Multigate Medical Products Pty Ltd

Should be restricted to higher risk devices such as Class III and AIMD as the cost for providing information for lower risk devices does not offset the public gain.

53

National Serological Reference Laboratory (NRL)

Support the TGA including on its website the depth of information similar to that published by NRL for IVDs. NRL suggest that this could be directly linked. It is unclear if the TGA will seek approval from manufacturers or sponsors prior to publication nor wether the TGA will set criteria for publication of such material. Manufacturers or sponsors may be reluctant to have material published even if the material is largely positive. It is also unclear how the TGA will treat applications that are withdrawn by the sponsor/manufacturer if the NRL recommends against an IVDs inclusion on the ARTG.

54

Nobel Biocare Australia Pty Ltd

May create confusion as the public may not understand the information, increase business costs to provide the material, feel that there is no benefit in publishing rejected applications. 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

For lower risk devices agrees to publish user instructions on the TGA website with responsibility lying with the sponsor. Does not see significant public benefit in any other information described being made available on the website.

56

NuVasive Australia & NZ Pty Ltd

Supports in part. Support for Class III devices and higher but not lower and only for information on approvals. Should not publish commercial in confidence material such as unpublished clinical trial data. Responsibility of authorship should be with the TGA however the sponsor must be consulted to review the proposed information. TGA should also be responsible for maintaining the information. Rejected applications should not be published. Making instructions for use publicly available will result in additional burdens on the medical devices industry and is also unnecessary given the information is already supplied to users.

57

Otto Bock Australia Pty Ltd

No comment.

58

Paragon Therapeutic Technologies Pty Ltd (PTT)

IPUs are generated by the TGA as part of the evaluation process for medicines and therefore a TGA document to place on the web. TGA does not approve IFUs or manuals for a device during the review process. Believes it provides no essential value, could cause confusion and the information is already available on the company websites. Concerns that this will create unnecessary high administrative overheads. Many medical devices are exclusively produced for healthcare practitioners and the information provided is tailored to them and see no use supplying this information to the patient. Many items are obvious as to their use and do not need an IFU and for some instructions are on the pack. If 3 (i) proceeds it would be possible to access the information through the internet.

59

Pfizer Australia Pty Ltd

Support for Class III and AIMDs and possibly only for those that have undergone Conformity Assessment by the TGA. The TGA should be responsible for authorship only if the documents relate to the decision making process. Do not support publishing of rejected applications as this may be taken out of context. The maintenance of substantial product information type documents is onerous especially for smaller Australian based manufacturers. Consider the manufacturer should be responsible for providing this information and the stakeholder responsible for the risk analysis. If a PI is considered necessary by stakeholders it should only be for higher risk medical devices. Suggest that IFUs could be provided by company websites as an alternative.

60

Queensland Health- Clinical and Statewide Services Division

No comment.

61

Queensland Health– Chief Health Officer

Support. There is a great opportunity to inform consumers and healthcare facilities about the latest developments, product performance. This could be supported by jurisdiction/facility product procurement and medical device review groups. Align with the National Product Catalogue.

62

Queensland Health– Centre for Healthcare Improvement

Fully support. Would be of great benefit to a consumer organisation such as Qld Health. It should include all devices. Should include information such as that on the FDA website, links between ARTG products that are used in combination or in a system, service manuals, amendments, relevant dates ie end dates, recalls, suspended, removed or withdrawn entry, relevant history of sponsor, manufacturer and distributor changes and the identity and address of official distributors. Manufacturer and sponsor should be responsible for the maintenance except for recalls etc.

Can see limited benefit in publishing rejection decisions unless the product is not a therapeutic good, or the product is still supplied in Australia, or for providing advice to a consumer organisation for replacement of the device. This information would be beneficial if an application is made to an ethics committee for a clinical trial or for the special access scheme.



63

Resmed

Oppose for Class IIb and below as the requirement would act as a default assessment process. Information is already available through the distribution network or online. Information required for higher risk devices should be limited to what is already required in the application audit.

64

Royal Australasian College of Physicians (RACP)

No comment.

65

RTI Biologics Inc

Generally support for product summary information regarding safety and effectiveness of higher risk devices such as Class III and AIMD. Recommend information authored by the manufacturer, if authored by the TGA the manufacturer should be able to review prior to publication to allow protection of proprietary information. TGA establish a system for timely updates by the manufacturer and further information should not be required until this system is established. Against posting device labelling on the TGA website and having two competing sources of information. Oppose disclosure of rejected applications. Could be detrimental to companies and new improved products.

66

Seating Dynamics Australia Pty Ltd

No comment.

67

Smith & Nephew Pty Ltd

Evidence is required for the need for this information. Needs further consultation.

68

Stryker Australia

Would create confusion and duplication as material is already available on the company website. The effort involved for sponsors/manufacturers to update this information would be a vast undertaking.TGA should examine the information captured during the application and review what data is made available on the public summary for each ARTG.

69

STS Health

Concerned at the depth of information required and will the TGA have a surveillance unit that verifies the information?

70

N/A

N/A

71

The Pharmacy Guild of Australia

Support. Would like information sheets for all medical devices that can be readily accessed by consumers and health care professionals. The information must be of use and its preparation should not be onerous. Should include: ARTG number; Device/product type; brand name; model number/s; classification level; Australian sponsor and contact details; information about correct use; information about maintenance (where relevant); and information about separate parts or consumables (where relevant).

Suggest a TGA campaign to educate consumers and health care professionals about TGA operations and related regulatory matters and resources.



72

TrioDent Ltd

No comment.

73

WelchAllyn

Information supplied should be a direct correlation to the information supplied for the device application. Do not support publication of rejected applications.

74

Whiteley Corporation Pty Ltd

No issue with publishing all material so long as full formulation details are not required for chemical products, only ingredients that are required for compliance with hazardous substances, scheduled substances and dangerous goods. For disinfectants the active ingredient should be listed. Responsibility for authoring and keeping up to date should lie with the sponsor/manufacturer. Rejected applications should not be published.

75

William Green Pty Ltd

Support for higher risk devices not low risk. Results in a very large one off cost and significant ongoing costs.

76

Zimmer Pty Ltd

Propose TGA only publish information for consumer products. Could publish: Device and application information; intended use; indications; instruction for use; warnings and precautions; contraindications; and care of the product. No public health benefit in disclosing rejected applications.

77

Zoono Solutions Pty Ltd

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



Reforms in the Medical Devices Regulatory Framework: Summary Table of Submissions Page of
1   2   3   4   5   6   7   8   9


The database is protected by copyright ©dentisty.org 2016
send message

    Main page