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



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Proposal 2C(ii)

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Respondent

Response


1

3M Australia Pty Ltd

No impact therefore no comments.

2

Abbott Australasia P/L (Diagnostics Division)

This proposal is encouraged as it provides flexibility for Australian manufacturers and has the potential to reduce regulatory burden. Questions the requirement to base the assessment bodies in Australia.

Recommends that TGA put in place a process to designate any suitable authority or body to undertake conformity assessment.



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

Supports. Suggests that where an acceptable overseas competent authority has designated a conformity assessment body then this should be acceptable by the TGA as meeting Australian requirements. The TGA could be an accrediting body whilst also being subject to independent assessment if it intends to continue to act as a conformity assessment body.

9

Australian Dental Association Inc (ADA)

Support. Will increase competition and choice for Australian manufacturers seeking the services of an assessment body.

10

Australian Dental Industry Association Inc (ADIA)

Support as it will increase competition amongst assessment bodies that support the Australian dental industry.

11

Australian Health Insurance Association (AHIA)

Support- the TGA should investigate the potential accreditation process being conducted by a third party body either locally (QA focussed) or overseas.

12

Australian Orthopaedic Association Limited

Prefer that clinical assessments were undertaken within Australia.

13

Baxter Healthcare Pty Limited

No comment.

14

BIOTRONIK Australia Pty Ltd

Fully supports.

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.

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 directly relevant but support moves by the TGA that increase the choice of Australian medical device manufacturers seeking the services of an assessment body.

27

Department of Innovation, Industry, Science and Research

Fully supported but has concerns that this does not appear to be an urgent area of reform.

28

Device Technologies Australia Pty Ltd

Proposes the TGA develop a system, within two years, by which third party assessment bodies can apply for designation to be given authority to issue Australian Conformity Assessment Certificates.

29

Draeger Medical Australia Pty Ltd

No comment.

30

Dynek Pty Ltd

Proposal 2C(ii) further undermines Proposal 2C(i). If a model can be presented for Australian based assessment bodies why hasn’t the TGA already done this with the EU notified bodies over its seven years experience. The recent release of the “TGA risk based approach to audit frequency” will exacerbate the costs associated with TGA audits. TGA’s explanations for introducing a more frequent audit regime show little understanding of the costs involved in making substantial changes in manufacture, including: staffing; procedures; equipment or location; and the validation of any change.

31

EBR Regulatory Affairs Consultants

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.

32

Erskine Dental

Welcomes this initiative.

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

Support as it will increase competition amongst assessment bodies that support the Australian dental industry.

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

Is supportive in principal but seeks additional detail on the determination of appropriate third party assessment bodies and whether they will be required to have a physical presence in Australia. Questions the need to have the assessment body based in Australia which is such a small market and may not get any interest. Also recommend that a separate office to the Office of Device Authorisation be set up to designate if the TGA is to designate.

44

Ivoclar Vivadent Pty Ltd

No comment.

45

Johnson & Johnson Medical Pty Ltd

Supports in principle although questions if there is sufficient volume of work to sustain an Australian third party conformity assessment body. Propose that CABs should not have to have physical or legal presence in Australia.

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. Suggests TGA no longer undertake CAs but oversight independent third party assessors or alternatively find an independent controlling body for all conformity assessors such as JAS-ANZ.

50

Medical Technology Association of Australia (MTAA)

Recommends that TGA take on the role of the accreditation authority to accredit conformity assessment bodies in Australia. If TGA is to be a conformity assessment body then it must be independently assessed, for example JAS-ANZ.

51

Medtronic Australasia Pty Ltd

Propose TGA retain its role as the Australian Competent Authority and its role as a Conformity Assessment Body. Propose that an independent body be the Designating Authority such as JAS-ANZ.

52

Multigate Medical Products Pty Ltd

No comment.

53

National Serological Reference Laboratory (NRL)

Propose uniform criteria and guidance for bodies that may become Australian third party assessment bodies to avoid bodies with different standards providing different quality of assessment.

54

Nobel Biocare Australia Pty Ltd

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

Support but suggest that the TGA ensure that this system copies the Competent Authority plus notified body arrangement in the EU that is a company that receives a CA certificate from the TGA-certified Australian based assessment body doesn’t have to also submit an application to the TGA.

57

Otto Bock Australia Pty Ltd

No comment.

58

Paragon Therapeutic Technologies Pty Ltd (PTT)

Supports. Should model the certification/recognition process on the one used in Europe for their respective legislation for consistency and harmonisation. The objectives and outcomes of the ongoing certification/recognition process should be publicly available to demonstrate the TGA is ensuring compliance. Support a single competent authority, TGA, to designate Australian third party assessors but not the TGA to offer CA services.

59

Pfizer Australia Pty Ltd

No comment.

60

Queensland Health- Clinical and Statewide Services Division

No comment.

61

Queensland Health– Chief Health Officer

Support. Please refer to Division of Chief Health Officer previous proposal and consider future involvement during the system development phase.

62

Queensland Health– Centre for Healthcare Improvement

No comment.

63

Resmed

Support. Has the potential to provide flexibility for Australian manufacturers. Should ensure Australian third party assessment bodies are not disadvantaged with respect to either EU Notified Bodies or the TGA.

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

Supports. Further consultation is required.

68

Stryker Australia

Supports and recommends that the TGA take on the accrediting role but no longer conformity assessment certification itself. Also allow bodies to be situated in both Australia and overseas.

69

STS Health

No comment.

70

N/A

N/A

71

The Pharmacy Guild of Australia

Support. Important that arrangements continue to meet high standards. Supports mandated TGA certification of devices classified as higher risk. Notes that it does not preclude the TGA from capitalising on rigorous overseas assessments. Also supports open and transparent discretion by the TGA to implement similar requirements for lower risk devices.

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

Propose TGA take on the role of designating body and make final regulatory decision but concerned at the conflict of interest if TGA is also a designating body.

77

Zoono Solutions Pty Ltd

No comment.
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