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Reforms in the medical devices regulatory framework

Consultation

2 November 2010

This consultation closed on 17 December 2010.

Relevant industry sectors, professional and consumer groups, and individuals were invited to provide comment and input to the consideration of the proposals outlined in this discussion paper.

Introduction

In response to a number of reviews of the regulatory burden on Australian manufacturers, competing calls for increased regulation of the safety and efficacy of therapeutic goods and changes to the international regulatory scene, the Therapeutic Goods Administration is calling for comments on a discussion paper on proposed changes to the third party conformity assessment for medical devices, amendments to the way in which a medical device is included in the Australian Register of Therapeutic Goods and enhancements to the identification of approved devices. This paper also details the proposed regulatory changes to the classification joint implants.

Discussion paper

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Public consultations

Public consultations were held on 13 November 2010 in Canberra, 16 November 2010 in Sydney, 23 November 2010 in Melbourne and 25 November 2010 in Adelaide.

Overview of submissions

An overview of submissions is available at: Reforms in the medical devices regulatory framework: Overview of submissions.

Summary table of submissions

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A summary table has been compiled and is available below.

Submissions received

The submissions received by the TGA are listed in alphabetical order of name of organisation.

  Submitter Description
1

3M Australia Pty Ltd (pdf,31kb)

Therapeutic Goods Industry: Devices Supplier
2

Abbott Australasia P/L (Diagnostics Division) (pdf,72kb)

Therapeutic Goods Industry: Devices Supplier
3

Advocate for the Consumer, Cosmetic, Hygiene and Specialty Products Industry (ACCORD) (pdf,38kb)

Therapeutic Goods Industry: Over the Counter Medicines / Complementary Medicines / Devices Organisation
4

Advanced Medical Technology Association (AdvaMed) (pdf,66kb)

Therapeutic Goods Industry: Devices Organisation
5

Amgen Australia (pdf,85kb)

Therapeutic Goods Industry: Devices Manufacturer and Supplier
6

AMPAC Dental Pty Ltd (pdf,30kb)

Therapeutic Goods Industry: DevicesSupplier
7

ANZ dental (pdf,36kb)

Therapeutic Goods Industry: Devices Supplier
8

Ausbiotech Ltd (pdf,237kb)

Biotechnology Industry Organisation
9

Australian Dental Association Inc (ADA) (pdf,112kb)

Healthcare: Professional Organisation
10

Australian Dental Industry Association (ADIA) (pdf,247kb)

Therapeutic Goods Industry: Devices Organisation
11

Australian Health Insurance Association (AHIA) (pdf,141kb)

Australian Private Health Industry Organisation
12

Australian Orthopaedic Association Limited (AOA) (pdf,175kb)

Healthcare Professional Organisation
13

Baxter Healthcare Pty Limited (pdf,33kb)

Therapeutic Goods Industry: Devices Supplier
14

BIOTRONIK Australia Pty Ltd (pdf,266kb)

Therapeutic Goods Industry: Devices Supplier
15

BORG Dental (Bordent Pty Ltd) (pdf,115kb)

Therapeutic Goods Industry: Devices Supplier
16

Bosco Medical Australia (pdf,98kb)

Therapeutic Goods Industry: Devices Supplier
17

Bourke Dental Supplies (pdf,73kb)

Therapeutic Goods Industry: Devices Supplier
18

CareFusion Australia & New Zealand (pdf,69kb)

Therapeutic Goods Industry: Devices Supplier
19

Carl Zeiss Vision (pdf,88kb)

Therapeutic Goods Industry: Devices Supplier
20

ConMed Corporation (pdf,127kb)

Therapeutic Goods Industry: Devices Supplier
21

Consumers Health Forum of Australia (CHF) (pdf,112kb)

Consumer Organisation
22

Cosmetic Physicians Society of Australasia Inc (pdf,188kb)

Healthcare Professional Organisation
23

Critical Dental Pty Limited (pdf,72kb)

Therapeutic Goods Industry: Devices Supplier
24

Dentalife Pty Ltd (pdf,28kb)

Therapeutic Goods Industry: Devices Supplier
25

Dentaurum Australia Pty Limited (pdf,72kb)

Therapeutic Goods Industry: Devices Supplier
26

Dentsply (Australia) Pty Ltd (pdf,62kb)

Therapeutic Goods Industry: Devices Supplier
27

Department of Innovation, Industry, Science and Research (pdf,104kb)

Government Organisation
28

Device Technologies Australia Pty Ltd (pdf,464kb)

Therapeutic Goods Industry: Devices Supplier
29

Draeger Medical Australia Pty Ltd (pdf,26kb)

Therapeutic Goods Industry: Devices Supplier
30

Dynek Pty Ltd (pdf,355kb)

Therapeutic Goods Industry: Devices Manufacturer and Supplier
31

EBR Regulatory Affairs Consultants (pdf,61kb)

Therapeutic Goods Industry: Devices Supplier Consultants
32

Erskine Dental (pdf,100kb)

Therapeutic Goods Industry: Devices Manufacturer and Supplier
33

Essology Pty Ltd (pdf,108kb)

Therapeutic Goods Industry: Devices Supplier (Dental)
34

Fisher & Paykel Healthcare Limited (pdf,38kb)

Therapeutic Goods Industry: Devices Manufacturer and Supplier
35

GE Health Care Australia Pty Ltd (pdf,72kb)

Therapeutic Goods Industry: Devices Manufacturer and Supplier
36

GlaxoSmithKline Australia Pty Ltd (pdf,101kb)

Therapeutic Goods Industry: Devices Manufacturer and Supplier
37

Gunz Dental Pty Ltd (pdf,87kb)

Therapeutic Goods Industry: Devices Supplier
38

Healthlinks.net Pty Ltd (pdf,136kb)

Therapeutic Goods Industry: Devices Supplier Consultants- Software
39

Henry Schein Halas (pdf,28kb)

Therapeutic Goods Industry: Devices Supplier (Dental)
40

Independent Rehabilitation Suppliers Association (IRSA) (pdf,86kb)

Therapeutic Goods Industry: Devices Organisation
41

Integra Neurosciences Pty Ltd (pdf,170kb)

Therapeutic Goods Industry: Devices Supplier
42

Invacare Australia Pty Ltd (pdf,102kb)

Therapeutic Goods Industry: Devices Manufacturer and Supplier
43

IVD Australia (pdf,277kb)

Therapeutic Goods Industry: Devices Organisation
44

Ivoclar Vivadent Pty Ltd (pdf,93kb)

Therapeutic Goods Industry: DevicesSupplier
45

Johnson & Johnson Medical Pty Ltd (pdf,272kb)

Therapeutic Goods Industry: Devices Manufacturer and Supplier
46

Johnson & Johnson Pacific and Vision Care Australia (pdf,77kb)

Therapeutic Goods Industry: Devices Manufacturer and Supplier
47a

Magic Mobility (Red Milawa Pty Ltd), John Dorning (pdf,39kb)

Therapeutic Goods Industry: Devices Manufacturer and Supplier
47b

Magic Mobility (Red Milawa Pty Ltd), Jill Barnett (pdf,35kb)

Therapeutic Goods Industry: Devices Manufacturer and Supplier
48

MAQUET Australia Pty Ltd (pdf,152kb)

Therapeutic Goods Industry: Devices Manufacturer and Supplier
49

Max Boccardo Associates (pdf,36kb)

Therapeutic Goods Industry: Devices Supplier Consultants
50

Medical Technology Association of Australia (MTAA) (pdf,222kb)

Therapeutic Goods Industry: Professional Organisation
51

Medtronic Australasia Pty Ltd (pdf,418kb)

Therapeutic Goods Industry: Devices Manufacturer and Supplier
52

Multigate Medical Products Pty Ltd (pdf,21kb)

Therapeutic Goods Industry: Devices Supplier
53

National Serology Reference Laboratories (pdf,78kb)

Therapeutic Goods Industry: Quality Assurance Validator
54

Nobel Biocare Australia Pty Ltd (pdf,144kb)

Therapeutic Goods Industry: Devices Manufacturer and Supplier
55

Novo Nordisk Pharmaceuticals Pty Ltd (pdf,42kb)

Therapeutic Goods Industry: Devices Manufacturer and Supplier
56

NuVasive Australia & NZ Pty Ltd (pdf,210kb)

Therapeutic Goods Industry: Devices Supplier
57

Otto Bock Australia Pty Ltd (pdf,95kb)

Therapeutic Goods Industry: Devices Manufacturer and Supplier
58

Paragon Therapeutic Technologies Pty Ltd (pdf,102kb)

Therapeutic Goods Industry: Devices Manufacturer, Supplier and Consultant
59

Pfizer Australia Pty Ltd (pdf,122kb)

Therapeutic Goods Industry: Devices Manufacturer and Supplier
60

Queensland Health, Centre for Healthcare Improvement (pdf,77kb)

Government Organisation
61

Queensland Health, Chief Health Officer (pdf,169kb)

Government Organisation
62

Queensland Health, Clinical and Statewide Services Division (pdf,38kb)

Government Organisation
63

ResMed (pdf,42kb)

Therapeutic Goods Industry: Devices Manufacturer and Supplier
64

Royal Australasian College of Physicians (RACP) (pdf,32kb)

Healthcare Professional Organisation
65

RTI Biologics Inc (pdf,316kb)

Therapeutic Goods Industry: Devices Manufacturer and Supplier
66

Seating Dynamics Australia Pty Ltd (pdf,130kb)

Therapeutic Goods Industry: Devices Supplier
67

Smith & Nephew Pty Ltd (pdf,37kb)

Therapeutic Goods Industry: Devices Manufacturer and Supplier
68

Stryker Australia (pdf,47kb)

Therapeutic Goods Industry: Devices Manufacturer and Supplier
69

STS Health (pdf,43kb)

Therapeutic Goods Industry: Devices Supplier
70 Not included at submitting organisation's request. N/A
71

The Pharmacy Guild of Australia (pdf,155kb)

Healthcare Professional Organisation
72

TrioDent Ltd (pdf,99kb)

Therapeutic Goods Industry: Devices Manufacturer and Supplier
73

WelchAllyn (pdf,31kb)

Therapeutic Goods Industry: Devices Manufacturer
74

Whiteley Corporation Pty Ltd (pdf,67kb)

Therapeutic Goods Industry: Devices Manufacturer and Supplier
75

William Green Pty Ltd (pdf,86kb)

Therapeutic Goods Industry: Devices Manufacturer and Supplier
76

Zimmer Pty Ltd (pdf,43kb)

Therapeutic Goods Industry: Devices Manufacturer and Supplier
77

Zoono Solutions Pty Ltd (pdf,85kb)

Therapeutic Goods Industry: Devices Manufacturer and Supplier