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



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Proposal 2C(i)

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Respondent

Response


1

3M Australia Pty Ltd

Support the proposal.

2

Abbott Australasia P/L (Diagnostics Division)

Supports although recommends that any inclusion of IVDs in the MRA not be undertaken until after the EU commission review is complete (approx 2015).

Does not support the option whereby only certificates issued by MRA notified bodies are accepted as Manufacturers Evidence nor that certification issued by non-MRA Notified Bodies undergo application audits. Does not align with global harmonisation nor is the level of risk commensurate with the level of regulatory oversight.



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

AMPAC Dental Pty Ltd

No comment.

6

Amgen Australia

No comment.

7

ANZ dental

No comment.

8

AusBiotech Ltd

Support. Recognises that the competence of Notified Bodies is critical and should be subject to rigorous assessment and supervision. Notes that the TGA already has several years experience with the medical devices regulatory framework, based on the GHTF model and could use this accumulated experience to shorten the timeframe for confidence building as well as consider the proposal to include notified bodies that the TGA accepts CE certification from as equivalent to TGA conformity assessment. Propose the TGA start with a subset of notified bodies already recognised under the MRA and seek further advice from the European competent authorities and industry to identify those most acceptable. Industry expects this reform to be implemented quickly.

9

Australian Dental Association Inc (ADA)

Support but with the qualification that this process conducted after a cost benefit study has been undertaken and proper project management principles are in place so that the TGA’s financial commitment is not open ended.

10

Australian Dental Industry Association Inc (ADIA)

Unsure of the impact on the Australian dental industry however support.

11

Australian Health Insurance Association (AHIA)

Support.

12

Australian Orthopaedic Association Limited

No comment.

13

Baxter Healthcare Pty Limited

No comment.

14

BIOTRONIK Australia Pty Ltd

Fully supports.

15

BORG Dental (Bordent Pty Ltd)

Unclear on the constructive reason for this proposal.

16

Bosco Medical Australia

No comment.

17

Bourke Dental Supplies

This proposal has implications internationally with the issuing of CE certificates from manufacturers. If the international companies have not had a CE certificate issued by an MRA authorised certification body we are quite unclear on the constructive reason for this proposal.

18

CareFusion Australia & New Zealand

This is a positive initiative.

19

Carl Zeiss Vision

No comment.

20

ConMed Corporation

Suggest TGA designate a reduced number of reputable NB accredited to issue EC Certificates and publish on website in addition or alternately initially recognise EC certificates issued by currently designated MRA NB until others become accredited.

21

Consumers Health Forum of Australia (CHF)

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

Will be important to clearly define the financial commitment required by both the TGA and the EC as part of the project management and to consult further with industry on how the financial commitment of the TGA will be funded.

27

Department of Innovation, Industry, Science and Research

Have some implementation concerns. If the TGA develops and publishes criteria for appropriate third party conformity assessment for use in future bilateral agreements and to be used for recognising Australian third party assessment bodies in Proposal 2C (ii) this is likely to increase confidence in notified bodies that conform with the criteria.

28

Device Technologies Australia Pty Ltd

Supports in principle. Does not support to only accept CE certificates from MRA notified bodies as manufacturer’s evidence. Propose that a definition and route for gaining designation as an MRA notified body is developed. Does not support the requirement that all applications supported by non-MRA notified bodies undergo a mandatory application audit.

29

Draeger Medical Australia Pty Ltd

No comment.

30

Dynek Pty Ltd

Proposal 2C (i) is unjust and inconsistent. Dynek’s understanding of the EU MRA is that the TGA is regarded as if it were another EU competent Authority and the MHRA has adequate confidence in any European Competent Authority for access to the UK market for CE marked devices but the TGA does not have the same reciprocal confidence.

31

EBR Regulatory Affairs Consultants

The confidence building period should be short. Are there costs with being on the MRA list? Under what circumstances will the TGA refuse supply if the MRA is used?

32

Erskine Dental

Strongly support but need to monitor to ensure cost effectiveness and financial commitment is not over extended.

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

Implications for Gunz Dental Pty Ltd if international companies that have not had CE certificate issued by an MRA authorised certification body. Unclear on the constructive reason for the proposal. Concerns with why an MRA needs to be established and that TGA’s financial commitment may be an open ended one.

38

Healthlinks.net Pty Ltd

No comment.

39

Henry Schein Halas

Unsure of the impact on the Australian dental industry however support.

40

Independent Rehabilitation Suppliers Association (IRSA)

No comment.

41

Integra Neurosciences Pty Ltd

Suggest undertaking this before implementing 2B. Suggest that CMDCAS QS certificates and Health Canada Product Licences where the device is equivalent be used. Also consider that certification issued by MRA notified bodies be acceptable for application audits whether the device has been manufactured in the EU or not.

42

Invacare Australia Pty Ltd

No comment.

43

IVD Australia

Is supportive but does not support the option that TGA give greater weight to EC certificates issued by notified bodies that have undergone confidence building. Also recommends that any changes to the MRA with Europe (for IVD medical devices) not be made until the introduction of the revised European IVD framework. Is opposed to all applications supported by non-MRA Notified Body certificates undergo a mandatory application audit. This would require many Class 2 and 3 products under the IVD regs to require a mandatory application audit which was a key negotiation point of the IVD framework. Also concerned that the proposal will exclude high quality notified bodies that chose not to sign up to the MRA.

44

Ivoclar Vivadent Pty Ltd

No comment.

45

Johnson & Johnson Medical Pty Ltd

Supports and believes that this should be extended beyond the MRA to include Notified Bodies from which CE certifications are accepted instead of TGA conformity assessment certification.

46

Johnson & Johnson Pacific and Vision Care Australia

No comment.

47

Magic Mobility (Red Milawa Pty Ltd)

No comment.

48

MAQUET Australia Pty Ltd

Another option is to only accept CE certificates from MRA notified Bodies as manufacturer evidence.

49

Max Boccardo Associates

Support. Strongly objects to linking this to 2C (ii).

50

Medical Technology Association of Australia (MTAA)

Recommends that:

  • A two year period for confidence building with alignment of requirements between approval of Notified Bodies outside of Australia, and those within Australia, with TGA as the accreditation authority; and

  • The use of JAS-ANZ processes or equivalent for accreditation processes and consideration of inclusion of bodies such as those accredited by USFDA and MHLW in Japan.

51

Medtronic Australasia Pty Ltd

TGA continue confidence building for a maximum of two years but also actively assess which Notified Bodies should be on the MRA approval list.

52

Multigate Medical Products Pty Ltd

No comment.

53

National Serological Reference Laboratory (NRL)

No comment.

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 it be undertaken with caution to ensure that companies with CE certificates from Notified Bodies that have not undergone confidence building are not adversely affected.

57

Otto Bock Australia Pty Ltd

No comment.

58

Paragon Therapeutic Technologies Pty Ltd (PTT)

The use of this process will not increase unless Class III devices are included and TGA is not the only certifier for Class III devices. Disappointed at the TGA’s lack of commitment to the MRA process by not having already initiated the confidence building process. What does the TGA expect from a confidence building exercise or how it should be structured? The objectives and the outcomes of the confidence building process should be published. TGA should consult the medical device industry to determine which Notified Bodies should be considered acceptable to continue with or be part of the MRA then approach the competent authorities that designated them for further advice. As a part of the MRA the Department of Health and Ageing should be part of the regular EU Notified Bodies Operation Group audit program of Notified Bodies. Should model the confidence building accreditation processes on what the Joint Accreditation System of Australia and New Zealand (JAS-ANZ) does to accredit certification companies and EU competent authorities does to designate Notifying Bodies.

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. For low and medium risk devices certificates issued by an EU notified body (93/42/EEC) should be acceptable. Also question if the intent of the proposal should include any third party certifying body assessed by the TGA as capable.

64

Royal Australasian College of Physicians (RACP)

No comment.

65

RTI Biologics Inc

Support. Believe it will strengthen the utility of the MRA and benefit both European manufacturers and the Australian public.

66

Seating Dynamics Australia Pty Ltd

No comment.

67

Smith & Nephew Pty Ltd

Case not adequately justified for further confidence building. TGA should elaborate why it is needed. Believe MRA should be extended to allow assessment of devices which require a TGA conformity assessment ie containing medicinal or animal content to allow simultaneous assessment by a European Notified Body for entry to the Australian and European markets.

68

Stryker Australia

TGA provide a clear objective surrounding confidence building. For TGA to increase the confidence level of a Notified Body an accreditation process should be introduced with appropriate training to improve the Notified Body’s understanding.

69

STS Health

No comment.

70

N/A

N/A

71

The Pharmacy Guild of Australia

Support.

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 implementing an accreditation and monitoring program for third party assessors. How will third party bodies be accredited, monitored and what is their role in reviewing and assessing all classes of medical devices.

77

Zoono Solutions Pty Ltd

No comment.
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