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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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- Discussion paper: Reforms in the medical devices regulatory framework (pdf,440kb)
- Discussion paper: Reforms in the medical devices regulatory framework (doc,539kb)
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 | Therapeutic Goods Industry: Devices Supplier | |
| 2 | 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 | Therapeutic Goods Industry: Devices Manufacturer and Supplier | |
| 6 | Therapeutic Goods Industry: DevicesSupplier | |
| 7 | Therapeutic Goods Industry: Devices Supplier | |
| 8 | Biotechnology Industry Organisation | |
| 9 | Healthcare: Professional Organisation | |
| 10 | Therapeutic Goods Industry: Devices Organisation | |
| 11 | Australian Private Health Industry Organisation | |
| 12 | Australian Orthopaedic Association Limited (AOA) (pdf,175kb) | Healthcare Professional Organisation |
| 13 | Therapeutic Goods Industry: Devices Supplier | |
| 14 | Therapeutic Goods Industry: Devices Supplier | |
| 15 | Therapeutic Goods Industry: Devices Supplier | |
| 16 | Therapeutic Goods Industry: Devices Supplier | |
| 17 | Therapeutic Goods Industry: Devices Supplier | |
| 18 | Therapeutic Goods Industry: Devices Supplier | |
| 19 | Therapeutic Goods Industry: Devices Supplier | |
| 20 | Therapeutic Goods Industry: Devices Supplier | |
| 21 | Consumer Organisation | |
| 22 | Healthcare Professional Organisation | |
| 23 | Therapeutic Goods Industry: Devices Supplier | |
| 24 | Therapeutic Goods Industry: Devices Supplier | |
| 25 | Therapeutic Goods Industry: Devices Supplier | |
| 26 | Therapeutic Goods Industry: Devices Supplier | |
| 27 | Department of Innovation, Industry, Science and Research (pdf,104kb) | Government Organisation |
| 28 | Therapeutic Goods Industry: Devices Supplier | |
| 29 | Therapeutic Goods Industry: Devices Supplier | |
| 30 | Therapeutic Goods Industry: Devices Manufacturer and Supplier | |
| 31 | Therapeutic Goods Industry: Devices Supplier Consultants | |
| 32 | Therapeutic Goods Industry: Devices Manufacturer and Supplier | |
| 33 | Therapeutic Goods Industry: Devices Supplier (Dental) | |
| 34 | Therapeutic Goods Industry: Devices Manufacturer and Supplier | |
| 35 | Therapeutic Goods Industry: Devices Manufacturer and Supplier | |
| 36 | Therapeutic Goods Industry: Devices Manufacturer and Supplier | |
| 37 | Therapeutic Goods Industry: Devices Supplier | |
| 38 | Therapeutic Goods Industry: Devices Supplier Consultants- Software | |
| 39 | Therapeutic Goods Industry: Devices Supplier (Dental) | |
| 40 | Independent Rehabilitation Suppliers Association (IRSA) (pdf,86kb) | Therapeutic Goods Industry: Devices Organisation |
| 41 | Therapeutic Goods Industry: Devices Supplier | |
| 42 | Therapeutic Goods Industry: Devices Manufacturer and Supplier | |
| 43 | Therapeutic Goods Industry: Devices Organisation | |
| 44 | Therapeutic Goods Industry: DevicesSupplier | |
| 45 | 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 | Therapeutic Goods Industry: Devices Manufacturer and Supplier | |
| 49 | Therapeutic Goods Industry: Devices Supplier Consultants | |
| 50 | Medical Technology Association of Australia (MTAA) (pdf,222kb) | Therapeutic Goods Industry: Professional Organisation |
| 51 | Therapeutic Goods Industry: Devices Manufacturer and Supplier | |
| 52 | Therapeutic Goods Industry: Devices Supplier | |
| 53 | Therapeutic Goods Industry: Quality Assurance Validator | |
| 54 | Therapeutic Goods Industry: Devices Manufacturer and Supplier | |
| 55 | Therapeutic Goods Industry: Devices Manufacturer and Supplier | |
| 56 | Therapeutic Goods Industry: Devices Supplier | |
| 57 | Therapeutic Goods Industry: Devices Manufacturer and Supplier | |
| 58 | Therapeutic Goods Industry: Devices Manufacturer, Supplier and Consultant | |
| 59 | Therapeutic Goods Industry: Devices Manufacturer and Supplier | |
| 60 | Queensland Health, Centre for Healthcare Improvement (pdf,77kb) | Government Organisation |
| 61 | Government Organisation | |
| 62 | Queensland Health, Clinical and Statewide Services Division (pdf,38kb) | Government Organisation |
| 63 | Therapeutic Goods Industry: Devices Manufacturer and Supplier | |
| 64 | Healthcare Professional Organisation | |
| 65 | Therapeutic Goods Industry: Devices Manufacturer and Supplier | |
| 66 | Therapeutic Goods Industry: Devices Supplier | |
| 67 | Therapeutic Goods Industry: Devices Manufacturer and Supplier | |
| 68 | Therapeutic Goods Industry: Devices Manufacturer and Supplier | |
| 69 | Therapeutic Goods Industry: Devices Supplier | |
| 70 | Not included at submitting organisation's request. | N/A |
| 71 | Healthcare Professional Organisation | |
| 72 | Therapeutic Goods Industry: Devices Manufacturer and Supplier | |
| 73 | Therapeutic Goods Industry: Devices Manufacturer | |
| 74 | Therapeutic Goods Industry: Devices Manufacturer and Supplier | |
| 75 | Therapeutic Goods Industry: Devices Manufacturer and Supplier | |
| 76 | Therapeutic Goods Industry: Devices Manufacturer and Supplier | |
| 77 | Therapeutic Goods Industry: Devices Manufacturer and Supplier |