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This consultation opened on 10 July 2008 and closed on 15 August 2008.
The following letter was sent to key industry organisations in July 2008. All interested stakeholders were invited to comment on this proposal.
Dear stakeholder
Consultation on updated Medical Device Standards Orders (MDSOs) and Conformity Assessment Standards Orders (CASOs)
The Therapeutic Goods Administration (TGA) is seeking your comments on a proposal to adopt the following 4 standards orders (Orders):
- Conformity Assessment Standards Order (Standards for Quality Management Systems and Quality Assurance Techniques) 2008 (CASO 1) (pdf,60kb)
- Medical Device Standards Order (Standards for Medical Devices Required to be Sterile) 2008 (MDSO 3) (pdf,60kb)
- Medical Device Standards Order (Standards for Natural Latex Rubber Condoms) 2008 (MDSO 4) (pdf,31kb)
- Medical Device Standards Order (Standards for Biological Safety and Biocompatibility of Medical Devices) 2008 (MDSO 5) (pdf,40kb)
Background
CASO 1 and MDSO 3
During January-February 2008 the TGA consulted on a proposal to adopt the following four Orders which had been updated to reflect the latest international standards:
- Conformity Assessment Standards Order (Standard for Quality Management Systems and Quality Assurance Techniques) 2008 (CASO 1)
- Medical Device Standards Order (Standards for Clinical Evidence) 2008 (MDSO 1)
- Medical Device Standards Order (Standards for Risk Management) 2008 (MDSO 2); and
- Medical Device Standards Order (Standards for Medical Devices Required to be Sterile) 2008 (MDSO 3)
MDSO 1 and MDSO 2 have now been finalised and the updated versions were registered on the Federal Register of Legislative Instruments (FRLI) on 28 May 2008.
CASO 1 and MDSO 3 both reference ISO 13408-1: 1998 which has recently been updated to ISO 13408-1: 2008 Aseptic processing of health care products - Part 1: General requirements. The TGA has therefore updated CASO 1 and MDSO 3 to also reference ISO 13408-1: 2008, with a proposal to phase out ISO 14408-1: 1998, in September 2009, in line with the European timeframes.
MDSO 4 and MDSO 5
MDSO 4 and MDSO 5 were developed during 2007 in preparation for the Australian New Zealand Therapeutic Products Authority (ANZTPA). These Orders, in ANZTPA format, had not yet been sent out for stakeholder comment when the postponement of the negotiations to establish ANZTPA was announced.
MDSO 4 Standards for Natural Latex Rubber Condoms adopts ISO 4074: 2002 as the standard that manufacturers should use for rubber condoms in order to demonstrate compliance with Essential Principles 2, 3, 4, 5, 6, 7 (except 7.4), 8.4 and 9.2.
MDSO 5 Standards for Biological Safety of Medical Devices adopts the ISO 10993 series as the standards that manufacturers should use in order to demonstrate the compatibility between the materials used in a device and biological tissues, cells and body fluids (Essential Principle 7.1(b)).
The use of MDSO 4 and MDSO 5 to demonstrate compliance with the relevant Essential Principles will not be mandatory. However, when these Orders are registered on the Federal Register of Legislative Instruments evidence of compliance with the standards referenced in these Orders will lead to an automatic presumption by the TGA that the medical device meets the relevant Essential Principles.
Your comments are sought on the proposal to register these four Orders in FRLI.
It is proposed that the new Orders be registered on FRLI as soon as practicable after the consultation period and that they commence on the day after they are registered in FRLI.
Yours sincerely
Larry Kelly
A/g Director
Office of Devices, Blood and Tissues
July 2008