Conformity Assessment Standards Order No. 2: Conformity Assessment Standards for Quality Assurance Techniques for Animal Tissues and their Derivatives utilised in the Manufacture of Medical Devices

Administered by Department of Health, Disability and Ageing

Legislation au F2007B00587 Not in force Legislative Instrument

Legislation content

 

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.

 

 

Overview

The Conformity Assessment Standards Order No. 2, made under section 41DC of the Therapeutic Goods Act 1989, was introduced to address the need for quality assurance in the use of animal tissues and their derivatives in the manufacture of medical devices. This Order was signed by the delegate of the Minister for Health and Ageing on 20 February 2003 and commenced on the date it was gazetted. It specifies quality management techniques for the analysis and management of risk, sourcing, collection, handling, and the elimination or inactivation of viral and transmissible agents related to animal materials used in medical devices. Although compliance with these standards is voluntary, adherence to the specified European standards ensures a minimum level of safety and quality, aligning with the scientific knowledge available at the time of their implementation. The Order encourages the adoption of additional or alternative validated safety assurance methods as scientific understanding evolves.

Scope and Application

The Conformity Assessment Standards Order No. 2 (CASO 2), established under section 41DC of the Therapeutic Goods Act 1989, sets forth quality assurance techniques for the sourcing, handling, and processing of animal tissues and their derivatives that are used in the manufacture of medical devices in Australia. This Order applies to entities and individuals involved in the manufacture of medical devices, specifically those who utilise animal materials in their production processes. While compliance with these standards is voluntary, adherence to them allows manufacturers to presume compliance with certain parts of the conformity assessment procedures outlined in the Therapeutic Goods (Medical Devices) Regulations 2002. The Order applies nationally across Australia and references three European standards that establish a minimum level of assessment for animal tissues and their derivatives, although it also acknowledges the necessity for ongoing vigilance due to the evolving nature of scientific knowledge in this field.

Key Provisions

The Conformity Assessment Standards Order No. 2 (CASO 2), established under section 41DC of the Therapeutic Goods Act 1989, details the quality assurance techniques for animal tissues and their derivatives used in medical devices (section 41DC). This Order, signed on 20 February 2003 and gazetted on 5 March 2003, outlines the necessary procedures for sourcing, handling, and ensuring the safety of animal materials in the manufacture of medical devices. These standards include risk management, viral elimination, and inactivation processes. CASO 2 references three European standards, EN 12442-1: 2000, EN 14675: 2005, and EN 12356: 2000, which set the minimum requirements for safety based on current scientific knowledge. These standards are normative, meaning they are integral to the process, and must be adhered to unless alternative validated methods are adopted in the future. Manufacturers of medical devices have the obligation to implement quality management systems that align with the standards set forth in CASO 2. While compliance with these standards is voluntary, if a manufacturer chooses to adhere to CASO 2 and applies it correctly, their quality management system is presumed to meet the conformity assessment procedures outlined in the Therapeutic Goods (Medical Devices) Regulations 2002 (section 41BI of the Act). This presumption aids in demonstrating compliance with regulatory requirements. Manufacturers must ensure that their processes for sourcing, handling, and processing animal tissues and derivatives meet the safety standards to avoid any risks associated with the use of these materials in medical devices. The Therapeutic Goods Act 1989 does not specify any offences, penalties, or civil/criminal consequences for non-compliance with CASO 2, as the standards are voluntary. However, failure to adhere to these standards may result in non-compliance with the Therapeutic Goods (Medical Devices) Regulations 2002. This non-compliance could lead to regulatory scrutiny and potential enforcement actions if it is determined that the medical devices do not meet the required safety and quality standards. While CASO 2 itself does not impose penalties, failure to meet the broader regulatory requirements could have significant legal and financial repercussions for the manufacturer, including product recalls, fines, and damage to reputation.

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Area of Law
Medical Law
Regulatory Standards
Instrument
Order
Concepts
Definitions & Interpretation
Regulatory Standards
Compliance Obligations
Catchwords
Quality Assurance Techniques
Conformity Assessment

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Sourced from the Federal Register of Legislation at 26 August 2026. For the latest information on Australian Government law please go to https://www.legislation.gov.au.