EXPLANATORY STATEMENT

Subject:  CONFORMITY ASSESSMENT STANDARDS ORDER NO. 2 – Conformity Assessment Standards for Animal Tissues and their Derivatives Utilised in the Manufacture of Medical Devices

Section 41DC, Therapeutic Goods Act 1989

OUTLINE

Conformity Assessment Standard Order No. 2  – Conformity Assessment Standard Order for Animal Tissues and their Derivatives Utilised in the Manufacture of Medical Devices (CASO 2) 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).

This Order specifies relevant quality assurance techniques for the analysis and management of risk, sourcing, collection, handling, viral and transmissible agent elimination and/or inactivation of animal materials and their derivatives utilised in the manufacture of medical devices.

CASO 2 was signed by the delegate of the Minister on 20 February 2003 and notified in the Commonwealth Gazette No. GN 9 on 5 March 2003.  CASO 2 commenced on the date it was gazetted.

BACKGROUND

The Act provides for the establishment and maintenance of a national system of controls relating to the quality, safety and efficacy 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 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 Order.

The conformity assessment procedures 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. Compliance with applicable conformity assessment standards is not required, but it is one way to establish compliance with the conformity assessment procedures set out in the Therapeutic Goods (Medical Devices) Regulations 2002 (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).

This Order specifies relevant quality assurance techniques, as described above, for animal materials and their derivatives which are utilised in the manufacture of medical devices.

Non-viable tissues and derivatives of vertebrate animal (excluding human) species are included in the scope of EN 12442-1: 2000.  Notwithstanding this limitation, subclause 1.7 of this particular standard addresses the use of principles within the standard being applied by analogy to materials derived from non-vertebrate organisms when the risks are considered relevant.  It is therefore envisaged that this standard could be used in relation to non-viable tissues and derivatives of both vertebrate animals and non-vertebrate organisms.

The three European standards adopted by reference in the Schedule, as amended, set a minimum level of assessment for application to animal tissues and their derivatives in line with published scientific knowledge at the time of their implementation.  Use of the term “normative” in the Schedule means that the matter is an integral part of the standard rather than just for guidance or information.  The constant evolution of scientific data in this field demands that the user maintain a vigilant and critical attitude to emerging scientific and technical mechanisms for assuring the safety of animal tissues and their derivatives. Consideration may be given to the adoption as conformity assessment standards of additional or alternative validated methods for assurance of safety, if and when they become available.

REGULATION IMPACT STATEMENT

Compliance with the proposed conformity assessment standards is voluntary and members of industry may choose alternative means to demonstrate compliance with the conformity assessment procedures in the Regulations.  There was overall support from all stakeholders, including industry and Standards Australia who were consulted during the development of the proposed new regulatory system for medical devices.  The Office of Regulation Review assessed the proposal for voluntary standards and as it is not prohibitive either in terms of costs or time delays, the proposal is considered to be non-regulatory and as such a Regulatory Impact Statement is not required.