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



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Proposal 2B(ii)

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Respondent

Response


1

3M Australia Pty Ltd

Suggest that the TGA further revise their internal evaluation process for Class iib applications rather than applying application audit.

  • All the required documentation for application audit would already be part of the submission and no need to apply application audit for class IIb implantables;

  • Proposal will significantly increase cost –Class IIb application fee is $810, application audit will increase cost to $5650;

  • In association with Proposal 3 every new device will undergo an application audit; and

  • Increased market authorisation period.

2

Abbott Australasia P/L (Diagnostics Division)

No comment

3

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

No comment

4

Advanced Medical Technology Association (AdvaMed)

Supports Medical Technology Association of Australia (MTAA) position

5

Amgen Australia

No comment.

6

AMPAC Dental Pty Ltd

No comment.

7

ANZ dental

No comment.

8

AusBiotech Ltd

Does not support due to the potentially enormous increase in regulatory burden. This proposal should also include provisions for mandatory timeframes for companies to plan product introductions more effectively.

9

Australian Dental Association Inc (ADA)

Not supported. Likely to have a negative impact on access to dental implants.

10

Australian Dental Industry Association Inc (ADIA)

Not supported. Suggest that a risk management approach be taken where application audits are only required for types of medical devices where safety performance issues arise and that the TGA engage in further discussions to define what safety or performance issues may require an application audit.

11

Australian Health Insurance Association (AHIA)

Support- ensure intra-ocular visco-elastic fluids are inclusive of liquids and gases. Would like to see included all device accessories integral to the operation of an Intermittent Pulse Generator in either a coronary, spinal or neural setting.

12

Australian Orthapaedic Associaiton Limited

See 2B (i).

13

Baxter Healthcare Pty Limited

Support for new implantable devices seeking registration. The cost for requiring existing implantable devices would be a heavy burden.

14

BIOTRONIK Australia Pty Ltd

Generally support this proposal however question the ability of the TGA to handle the increased workload.

15

BORG Dental (Bordent Pty Ltd)

Do not support. Will have significant impact on the dental industry. Impost of an audit cost will impact on the viability of the devices, restrict range, availability and promotional viability and lead to increased costs to the consumer.

16

Bosco Medical Australia

No comment.

17

Bourke Dental Supplies

Do not support. Significant impact on the dental industry leading to increased costs to professionals and consumers. Restrict the range, availability and promotional viability.

18

CareFusion Australia & New Zealand

This is a positive initiative.

19

Carl Zeiss Vision

No comment.

20

ConMed Corporation

Similarly lead to increased regulatory cost, burden and delays similar to 2B (i).

21

Consumers Health Forum of Australia (CHF)

Welcomes improvements to implant classification. Support provided all of proposal 2 goes forward.

22

Cosmetic Physicians Society of Australasia Inc

No comment.

23

Critical Dental Pty Limited

No comment.

24

Dentalife Pty Ltd

No comment.

25

Dentaurum Australia Pty Limited

No comment.

26

Dentsply (Australia) Pty Ltd

Under the current fee structure this would increase costs from $810 to approximately $4000 for each approval leading to increased costs for consumers. Does not support unless dental implants are excluded. Would prefer to adopt regular reviews of devices to undergo an application audit and only add dental devices if safety or performance issues arise.

27

Department of Innovation, Industry, Science and Research

Concerned at any increase in regulation without demonstrated safety issues which is at odds with the HTA review.

28

Device Technologies Australia Pty Ltd

Does not support due to lack of detail. If this proposal proceeds then suggest that the TGA implement methods to ensure faster processing times for level two application audits and a significant fee reduction following a comprehensive cost impact survey.

29

Draeger Medical Australia Pty Ltd

No comment.

30

Dynek Pty Ltd

See comments for Proposal 2B (ii).

31

EBR Regulatory Affairs Consultants

TGA should guarantee that this will not affect turnaround time for reviews.

32

Erskine Dental

Support in principle.

33

Essology Pty Ltd

No comment.

34

Fisher & Paykel Healthcare Limited

No comment.

35

GE Health Care Australia Pty Ltd

No comment.

36

GlaxoSmithKline Australia Pty Ltd

No comment.

37

Gunz Dental Pty Ltd

This will have an impact on the import of Maxillo-Facial implants. Increased audit costs will impact on the viability, range, availability promotional viability and increase cost to market and the patient.

38

Healthlinks.net Pty Ltd

No comment.

39

Henry Schein Halas

Not supported. Suggest that a risk management approach be taken where application audits are only required for types of medical devices where safety performance issues arise and that the TGA engage in further discussions to define what safety or performance issues may require an application audit.

40

Independent Rehabilitation Suppliers Association (IRSA)

No comment.

41

Integra Neurosciences Pty Ltd

Require a longer implementation period- minimum 2 years. Would require more consultation and would like to know the costs involved. Need further evidence that this provides a sound evidence basis for the Commonwealth HTA process.

42

Invacare Australia Pty Ltd

No comment.

43

IVD Australia

No comment.

44

Ivoclar Vivadent Pty Ltd

No comment.

45

Johnson & Johnson Medical Pty Ltd

Agrees that increased scrutiny is appropriate for Class IIb, Class III and AIMD devices. However this should not require the introduction of level 2 application audits and TGA conformity assessment certificates. Increased oversight of international agencies and acceptance of certification from those demonstrating high standards would serve the same purpose.

46

Johnson & Johnson Pacific and Vision Care Australia

No comment.

47

Magic Mobility (Red Milawa Pty Ltd)

No comment.

48

MAQUET Australia Pty Ltd

Dependent upon the level of fees this could drastically limit new products coming to market. Suggest the TGA limit fees to well below current level 2 application audit fee of $5650.

49

Max Boccardo Associates

Support.

50

Medical Technology Association of Australia (MTAA)

Recommends:

  • expanding the current application audits to include products approved by Health Canada and US FDA as the basis for an entry in the ARTG; and

  • implementing a statutory timeframe.

51

Medtronic Australasia Pty Ltd

Proposes an application audit which comprises:

  • Australian Declaration of Conformity;

  • IFU/labels;

  • Risk management file; and

  • Clinical evidence supplied for CE marking.

Variations to Class IIb should be by notification as proposed in 3 (i).

52

Multigate Medical Products Pty Ltd

No comment.

53

National Serological Reference Laboratory (NRL)

No comment.

54

Nobel Biocare Australia Pty Ltd

This will have an impact on the availability of new medical devices resulting in delays to patients. Propose that the review be limited to safety and performance of the device as in the US or allow a manufacturer to declare conformance to essential principles like the EU system. The EU only requires an application audit for new products Class II and above or if the new product range would fall outside of the approved manufacturing scope of a given company granted by the Notified body (EC licence). Welcomes a continued MRA system for Class IIb and encourages the concept of qualifying individual notified bodies as capable of mutual recognition through confidence building.

55

Novo Nordisk Pharmaceuticals Pty Ltd

No comment.

56

NuVasive Australia & NZ Pty Ltd

Does not support without supporting evidence to justify additional fees and longer approval times.

57

Otto Bock Australia Pty Ltd

No comment.

58

Paragon Therapeutic Technologies Pty Ltd (PTT)

Inconsistent with the agreed GHTF classification rules. No demonstrated increase in risk to reclassify these products. Will lead to higher compliance costs. Suggest that this change only apply to new inclusions.

59

Pfizer Australia Pty Ltd

No comment.

60

Queensland Health- Clinical and Statewide Services Division

No comment.

61

Queensland Health– Chief Health Officer

Support.

62

Queensland Health– Centre for Healthcare Improvement

No comment.

63

Resmed

Support. The current approach is burdensome on Resmed and similar Australian manufacturers that distribute locally and overseas.

64

Royal Australasian College of Physicians (RACP)

No comment.

65

RTI Biologics Inc

No comment.

66

Seating Dynamics Australia Pty Ltd

No comment.

67

Smith & Nephew Pty Ltd

Does not support. In the spirit of harmonisation, TGA should accept evidence of CE marking as suitable evidence for entry to the Australian market.

68

Stryker Australia

Understands the perceived need.

69

STS Health

No comment.

70

N/A

N/A

71

The Pharmacy Guild of Australia

No comment.

72

TrioDent Ltd

No comment.

73

WelchAllyn

No comment.

74

Whiteley Corporation Pty Ltd

No comment.

75

William Green Pty Ltd

No comment.

76

Zimmer Pty Ltd

Support for new applications but propose TGA accept the EU notified Bodies Design Examination Certificates for existing devices.

77

Zoono Solutions Pty Ltd

No comment.



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