Tags
AdvaMed, Australia, Food & Drug Administration, Institute of Medicine, Jeffrey Shuren, Medical device, Medical technology, Therapeutic Goods Administration
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 |
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
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