EXPLANATORY STATEMENT

Subject:  CONFORMITY ASSESSMENT STANDARDS ORDER NO. 1 OF 2005 – QUALITY MANAGEMENT SYSTEMS AND QUALITY ASSURANCE TECHNIQUES

Section 41DC, Therapeutic Goods Act 1989

OUTLINE

Conformity Assessment Standards Order No. 1 of 2005 – Quality Management Systems and Quality Assurance Techniques (the Order) is an Order made by the delegate of the Minister for Health and Ageing under section 41DC of the Therapeutic Goods Act 1989 (the Act).

The Order revokes and replaces Conformity Assessment Standards Order No. 1 that was made on 20 February 2003 (CASO 1 of 2003) and commenced upon its gazettal on 5 March 2003.  CASO 1 of 2003 specified particular standards as conformity assessment standards relevant to the implementation of the manufacturer's quality management system and quality assurance techniques.

The Order introduces new conformity assessment standards for quality management systems for the manufacture of all kinds of medical devices that require conformity assessment.  The new standards are based on Australian standard AS ISO 13485-2003 Medical devices – Quality management systems – Requirements for regulatory purposes.  This standard is identical to international standard ISO 13485:2003 Medical devices – Quality management systems – Requirements for regulatory purposes.  The Order also makes it a condition that certain standards will no longer apply after 31 July 2006.

The Order commenced on the day after it was registered on the Federal Register of Legislative Instruments.

BACKGROUND

The Act provides for the establishment and maintenance of a national system of controls relating to the quality, safety, efficacy and timely availability of therapeutic goods that are used in Australia or exported from Australia.

Section 41DC of the Act provides the Minister, or the Minister’s delegate, with the power to determine in relation to the manufacture of medical devices, conformity assessment standards and to also determine that quality management systems implemented by the manufacturer that comply with these standards are to be treated as having had applied to them the parts of the conformity assessment procedures specified in the standards.

The requirement for a quality management system has been established in the medical devices legislation and the standards referenced in the Order provide a means that industry may use to meet the legislative requirements.

The International Standards Organisation (ISO) describes a quality management system as a set of interrelated or interacting processes and interfaces, whose purpose is to achieve defined objectives, within the constraints of established policy.  The system is to direct and control a group of people and facilities, with an arrangement of responsibilities, authorities and relationships.  Such controls and arrangements are necessary to ensure that the outputs of the system have a set of predetermined inherent and distinguishing features that fulfil a need or expectation that is stated generally, implied or obligatory.

The Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations) defines a set of safety and performance principles, the Essential Principles, which are obligatory expectations for medical devices supplied in Australia.
 

The general principles require that medical devices do not compromise the clinical condition of a patient when used as intended by persons with the appropriate knowledge and skills.  Any side effects from use of the device must not outweigh the benefits of the device.  Any risks associated with the use of a device must be identified, assessed and mitigated by inherent design, protection mechanisms and by informing users of any residual risk arising from shortcomings in the design or protection mechanisms.  The devices must perform as intended and stated by the manufacturer for the lifetime of the device.  Transport and storage must not adversely affect the performance of the device. 

Specific principles in relation to the technological characteristics of the design and manufacture of a device require that risks that might arise from these characteristics be identified, assessed and mitigated to a tolerable level.

The conformity assessment procedures, specified in the Regulations, set out the requirements relating to the application of quality management systems for the manufacture of medical devices and other requirements relating to the obligations of manufacturers of medical devices.  They provide the means by which a manufacturer may consistently show that medical devices will conform to the Essential Principles.  Dealing in medical devices that have not had the conformity assessment procedures applied may be an offence.  Conformity with applicable conformity assessment standards determined by an Order under section 41DC of the Act is not mandatory, but it is one way to establish conformity with the conformity assessment procedures in the Regulations.  If a manufacturer chooses to apply a conformity assessment standard, and this is applied correctly, the manufacturer's quality management system is presumed to comply with the parts of the conformity assessment procedures set out in the Order (section 41BI of the Act).

An order establishing a conformity assessment standard for a medical device may be specified by reference to, among other things, a standard published by a standards organisation including Standards Australia Limited and the International Organisation for Standardisation (section 41DD of the Act).

Electronic or hard copies of AS ISO 13485-2003 Medical devices – Quality management systems – Requirements for regulatory purposes or ISO 13485:2003 Medical devices – Quality management systems – Requirements for regulatory purposes can be purchased on-line from SAI Global Limited, which is accessible at the following website - www.standards.com.au.

CHANGES TO STANDARDS

ISO 13485:2003 Medical devices – Quality management systems – Requirements for regulatory purposes has implemented a change in approach to quality management systems in that the new standard -

         is a stand alone standard, that combines some elements of other earlier standards ISO 13485:1996, ISO 13488:1996 and ISO 9001:2000;

         reflects current best practice for quality management systems;

         is designed for regulatory purposes, in that it requires the regulatory requirements, both the Essential Principles and conformity assessment procedures, to be an objective of the quality management system;

         places emphasis on a process approach to a management system;

         includes risk management as an integral part of the quality management system; and

         clarifies the expectation for the control of manufacture by prescribing a requirement for written procedures for each aspect of the quality management system. 

It is now clear that prescribed regulatory requirements must be integrated into the quality management system.  There are specific requirements in relation to corrective and preventative action that must be undertaken in the post-production phase.

ISO 13485:2003 Medical devices – Quality management systems – Requirements for regulatory purposes was developed as a stand alone standard and reflects current best practice for quality management systems.  ISO 13485:2003 has also been adopted by Standards Australia Limited as AS ISO 13485-2003.

The Global Harmonisation Task Force (GHTF) encourages countries to use the standard ISO 13485:2003 for regulatory purposes.  The GHTF is a voluntary group of representatives from national medical device regulatory authorities and the regulated industry.  Australia is one of the five founding GHTF members.  The purpose of the GHTF is to encourage the convergence in regulatory practices related to ensuring the safety, effectiveness/performance and quality of medial devices, promoting technological innovation and facilitating international trade.  The GHTF has supported the International Organisation for Standardisation in the development of ISO 13485:2003 and the Therapeutic Goods Administration (TGA) participated in the committee that developed this standard.

There will be a transition period until 31 July 2006 where AS ISO 13485:2002 (identical to (ISO 13485:1996), AS ISO 13488:2002 (identical to ISO 13488:1996) or AS ISO 13485-2003 (identical to ISO 13485:2003) will be accepted by the TGA as acceptable conformity assessment standards.  From the end of the transition period, ISO 13485:1996 and ISO 13488:1996 will cease to constitute a conformity assessment standard for quality management systems for the manufacture of medical devices.  The transition period will allow industry to comply with the requirements of the new standard for quality management systems, although those members of industry that have implemented ISO 13485:1996 would be aware of the new ISO standard and it is expected that minimal change would be required to comply.

CONSULTATION

Conformity with the proposed conformity assessment standard is voluntary and members of industry may choose alternative means to demonstrate conformity with the conformity assessment procedures in the Regulations.  There was overall support for the mechanism of conformity assessment from all stakeholders, including industry and Standards Australia Limited that were consulted during the development of the proposed new regulatory system for medical devices.  Voluntary standards are decided upon in consultation with industry and regulators worldwide.  In consultation with SAI Global Limited and its expert committees, including industry representation, it was agreed to adopt ISO 13485:2003 as AS ISO 13485-2003. 

The TGA consulted with key industry stakeholders on the proposed changes to CASO 1 of 2003 on 6 May 2005.  The only response received was from the Medical Industry Association of Australia (MIAA) and it was supportive of the proposal.

REGULATION IMPACT STATEMENT

The Office of Regulation Review has assessed this proposal and advised that a Regulation Impact Statement is not necessary as the proposal is of a minor or machinery nature and does not substantially alter existing arrangements (ORR ID 7591).