Tags

, , , , , , ,


Australian TGA – Reforms in the medical devices regulatory framework

Consultation Source: TGA – Click here

2 November 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.

Consultation Framework

 

 

 

Submissions Summary

 

 

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

Top of page

Content last updated: Friday, 11 February 2011

Content last reviewed: Friday, 11 February 2011

Web page last updated: Tuesday, 3 May 2011

URL: http://www.tga.gov.au/newsroom/consult-devices-reforms-101130.htm

 

Advertisements