The changing regulatory environment of in vitro diagnostics: Implications for sponsors, manufacturers and laboratory users

Australian Journal of Medical Science

Volumn 31, Issue 1, 2010, Pages 9-15

  Cohen, Paul ^a  

^a DevDx Clinical Pty Ltd   (Australia)

Author keywords

In service training; Laboratory personnel; Medical science; Pathology; Professional status; Scientist; Staff development

Indexed keywords

AUSTRALIA; CLINICAL ASSESSMENT; COMMERCIAL PHENOMENA; DIAGNOSTIC KIT; DIAGNOSTIC PROCEDURE; EQUIPMENT; IN VITRO STUDY; LABORATORY TEST; REVIEW; SCIENTIST; SELF EVALUATION;

EID: 77950531915     PISSN: 10381643     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (11)

1. Australian Government Department of Health and Ageing Therapeutic Goods Administration. 2007. In vitro diagnostic devices - definitions and links. . Accessed 8 February 2010.
2. 2008. Current regulation of in vitro diagnostic devices (IVDs) in Australia. Fact sheet 8 September 2008.. Accessed 8 February 2010.
3. 2009. Overview of the new regulatory framework for in vitro diagnostic medical devices (IVDs) Feb 2009. Accessed 8 February 2010.
4. Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in-vitro diagnostic medical devices.
5. Global Harmonisation Task Force GHTF/SG1/N045:2008. Final Document: Global Harmonization Task Force-Principles of In Vitro Diagnostic (IVD) Medical Devices Classification, 19 Feb 2008. .
6. ISO 13485: 2003. Medical devices-quality management systems - Requirements for regulatory purposes.
7. National Pathology Accreditation Advisory Council. 2007. Requirements for the Use of In-House In Vitro diagnostic Devices, 2007. . Accessed 8 February 2010.
8. Therapeutic Goods Act 1989 (Commonwealth).
9. Therapeutic Goods Advertising Code 2007 (Commonwealth).
10. Therapeutic Goods Amendment (Medical Devices) Act 2002 (Commonwealth) . Accessed 8 February 2010.
11. Therapeutic Goods Regulation 1990 (Commonwealth).