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



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Proposal 2

Proposal 2A

#

Respondent

Response


1

3M Australia Pty Ltd

No effect on business, however supports

2

Abbott Australasia P/L (Diagnostics Division)

Whilst not an Australian manufacturer of IVDs supports this proposal.

3

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

Support- with the certification of these assessment bodies to be undertaken by the National Association of Testing Authority (NATA).

4

Advanced Medical Technology Association (AdvaMed)

Supports Medical Technology Association of Australia (MTAA) position

5

Amgen Australia

Supports

6

AMPAC Dental Pty Ltd

No comment

7

ANZ dental

No comment

8

AusBiotech Ltd

Support however have concerns that linking this proposal with 2B and 2C would result in additional delays and that concessions granted in 2A would be nullified in 2B for some products.

9

Australian Dental Association Inc (ADA)

No comment.

10

Australian Dental Industry Association Inc (ADIA)

Minimal impact on the Australian dental industry, however support.

11

Australian Health Insurance Association (AHIA)

Support- Ensure alignment of risk stratification rules with Australia and robust implementation of proposal 2C (i).

12

Australian Orthopaedic Association Limited

No comment.

13

Baxter Healthcare Pty Limited

No comment.

14

BIOTRONIK Australia Pty Ltd

No comment

15

BORG Dental (Bordent Pty Ltd)

No comment

16

Bosco Medical Australia

No comment

17

Bourke Dental Supplies

No comment

18

CareFusion Australia & New Zealand

This is a positive initiative.

19

Carl Zeiss Vision

No comment

20

ConMed Corporation

No comment

21

Consumers Health Forum of Australia (CHF)

Supports the whole proposal as long as they are taken together.

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

Not relevant directly but support.

27

Department of Innovation, Industry, Science and Research

Strongly supports. While the approach will have positive impacts much will depend on the coverage of the proposed change and the effect of the proposed change, if the TGA will accept certificates for all classes of device.

28

Device Technologies Australia Pty Ltd

Supports and considers that this can be implemented irrespective of Proposal 2B.

29

Draeger Medical Australia Pty Ltd

No comment.

30

Dynek Pty Ltd

Concerned that any concessions in Proposal 2A are nullified by Proposal 2B. Proposal 2B appears to withdraw the possibility of utilising CE certification to support their ARTG entry for Class IIb and Class III products.

31

EBR Regulatory Affairs Consultants

TGA should guarantee that this will not affect turnaround time for reviews. The confidence building period should be short. Are there costs associated with being on the MRA list? The recognition of third party assessments is taking too long. It is not clear if the TGA has a role in designating CABs via the MRA. Under what circumstances will the TGA refuse supply if the MRA is used?

32

Erskine Dental

Little impact but support the change.

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

No comment

38

Healthlinks.net Pty Ltd

No comment

39

Henry Schein Halas

Minimal impact on the Australian dental industry, however support.

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

Supportive.

44

Ivoclar Vivadent Pty Ltd

No comment

45

Johnson & Johnson Medical Pty Ltd

Support.

46

Johnson & Johnson Pacific and Vision Care Australia

No comment

47

Magic Mobility (Red Milawa Pty Ltd)

No comment

48

MAQUET Australia Pty Ltd

No comment

49

Max Boccardo Associates

Support. Proposal 2A and 2C(ii) should be treated as one.

50

Medical Technology Association of Australia (MTAA)

Supports.

51

Medtronic Australasia Pty Ltd

Support- but TGA needs to ensure that the timing of this coincides with the approval or designation of Conformity Assessment Bodies operating in Australia to prevent the situation of manufacturers choosing a Conformity Assessment Body that is later not approved.

52

Multigate Medical Products Pty Ltd

No comment.

53

National Serological Reference Laboratory (NRL)

Accepting conformity assessment from third parties (particularly Europe) is inconsistent with Recommendation 8 (c) of the HTA review. Suggest that the quality of information provided by the European Notified Bodies be improved dramatically, standardised and monitored before they could be of use to Australia.

54

Nobel Biocare Australia Pty Ltd

No comment.

55

Novo Nordisk Pharmaceuticals Pty Ltd

No comment.

56

NuVasive Australia & NZ Pty Ltd

Support. Removes the disparity between Australian and overseas manufacturers.

57

Otto Bock Australia Pty Ltd

No comment

58

Paragon Therapeutic Technologies Pty Ltd (PTT)

Supports. Unclear who will be responsible for the appointment of third party CABs.

59

Pfizer Australia Pty Ltd

No comment.

60

Queensland Health- Clinical and Statewide Services Division

Questions the requirements of the quality standards of third party assessors. Also unclear as to which authority will regulate these third parties or how third parties will guarantee quality of product.

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

Broadly supports but seeks further details on the recognition of third party assessment bodies.

68

Stryker Australia

Supports.

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.

77

Zoono Solutions Pty Ltd

No comment.



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