Devices Guidelines, 16-27 November 2009
This article was originally published in RAJ Devices
Executive Summary
Device-Related Guidelines – Worldwide Developments
Device-Related Guidelines – Worldwide Developments
Recently updated and newly issued documents
Title | Status |
Australia | |
Proposed S38A guidelines for Australian manufacturing licences covering multiple manufacturing sites Therapeutic Goods Administration, 18 November 2009 | Draft Submit comments by 14 December 2009 |
International | |
Quality management system – Medical Devices – Guidance on corrective action and preventive action and related QMS processes Global Harmonization Task Force, SG3(PD)/N18R8, 22 September 2009 (posted 25 November 2009) | Draft Submit comments by 25 April 2010 |
Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers – Part 5: Audits of manufacturer control of suppliers Global Harmonization Task Force, SG4N84R12, 13 November 2009 (posted 25 November 2009) | Draft Submit comments by 25 March 2010 |
Sources
Australia: www.tga.gov.au
International: www.ghtf.org