Medical Device Standards Order (Standards for Biological Safety of Medical Devices) 2008

Administered by Department of Health, Disability and Ageing

Legislation au F2008L04338 Not in force Legislative Instrument

Legislation content

EXPLANATORY STATEMENT

 

Subject:  MEDICAL DEVICE STANDARDS ORDER (STANDARDS FOR BIOLOGICAL SAFETY OF MEDICAL DEVICES) 2008 

 

Section 41CB, Therapeutic Goods Act 1989

 

OUTLINE

 

Medical Device Standards Order (Standards for Biological Safety of Medical Devices) 2008 (MDSO (Biological Safety) 2008) is an Order made by the delegate of the Minister for Health and Ageing under section 41CB of the Therapeutic Goods Act 1989 (the Act).  Section 41CB of the Act authorises the Minister, or her delegate, by written Order, to determine appropriate medical standards that are applicable to kinds of medical devices and to determine that medical devices that comply with those standards are to be treated as complying with those parts of the essential principles specified in the standards.

 

MDSO (Biological Safety) 2008 introduces standards (or parts of these standards) published by standards organisations that are relevant to biological safety of medical devices in order to demonstrate compliance with essential principle 7.1(b).  The standards set out in MDSO (Biological Safety) 2008 are Parts 1, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17 and 18 of ISO 10993 Biological evaluation of medical devices. 

 

Electronic or hard copies of this standard can be purchased on-line from SAI Global Limited at the following website: http://www.saiglobal.com.

 

MDSO (Biological Safety) 2008 was signed by the delegate of the Minister on 14 November 2008 and 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 and efficacy of therapeutic goods that are used in Australia (whether manufactured in Australia or elsewhere) or exported from Australia.

 

Section 41CB of the Act authorises the Minister, or the Minister’s delegate, by written instrument called an Order, to determine medical device standards for kinds of medical devices set out in the Order and to determine that medical devices of those kinds that comply with the standard are to be treated as complying with those parts of the essential principles specified in the standard.

 

The essential principles set out the requirements relating to the safety and performance characteristics of medical devices that must be complied with before a device can be imported, supplied or exported.  Compliance with applicable medical device standards is not required, but it is one way to establish compliance with the essential principles.  If a manufacturer chooses to apply a medical device standard set out in the Order, and this is applied correctly to a device, the device is presumed to comply with the parts of the essential principles set out in the Order (section 41BH of the Act).

 

MDSO (Biological Safety) 2008 determines medical device standards, which set methods for risk analysis and risk management in order to demonstrate compliance of medical devices with the essential principles.

 

CHANGES TO STANDARDS

 

International ‘ISO’ and ‘EN’ device standards are living documents that are developed and constantly being updated by groups of international experts.  Australian representatives are involved in some of these committees.  There is extensive consultation on the ISO and EN standards during their development and subsequent review.  With both industry and the TGA seeking to optimise Australia’s position in the global device market, it is imperative that Australia’s standards do not fall out of step with the international market.

 

Updates to international device standards reflect changes to international best practice as well as the emergence of new technologies and new manufacturing procedures.  Where relevant the latest international standards are adopted by leading regulators including Australia, Europe, the USA and Canada.

 

Australia will very quickly fall behind if it fails to adopt the latest international standards.  In the longer term not keeping up with changes to the relevant international standards will lead to a unique regulatory system in Australia, making regulatory compliance more difficult and costly for importers and/or exporters of medical devices into Australia.  The updated standards referenced in MDSO (Biological Safety) 2008 reflect the current relevant international standards for clinical investigation.

 

CONSULTATION

 

Key industry stakeholders including the Medical Industry Association of Australia (now the Medical Technology Association of Australia), the Australian Dental Industry Association and AusBiotech were consulted on the adoption of MDSO (Biological Safety) 2008 during July-August 2008.  Industry groups supported the adoption of these standards. 

 

REGULATION IMPACT STATEMENT

 

Compliance with the proposed medical device standards is voluntary and members of industry may choose alternative means to demonstrate compliance with the Essential Principles.  All stakeholders, including industry and Standards Australia have been consulted during the development of the proposed new regulatory system for medical devices.  There was overall support for the adoption of international standards.  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.

 

APPLICATION OF THE LEGISLATIVE INSTRUMENTS ACT 2003 (THE LIA)

 

Under paragraph 6(d)(i) of the LIA, an instrument is a legislative instrument for the purposes of the LIA if it is declared to be a disallowable instrument under legislation in force before the commencement of the LIA.  This determination is a legislative instrument and it is subject to tabling and disallowance in the Parliament under sections 38 and 42 of the LIA, respectively.

 

Overview

The Medical Device Standards Order (Standards for Biological Safety of Medical Devices) 2008 (MDSO (Biological Safety) 2008) was introduced under section 41CB of the Therapeutic Goods Act 1989, allowing the Minister for Health and Ageing, or their delegate, to set specific standards for medical devices that demonstrate compliance with the Act's essential principles. This legislative instrument addresses the need for Australia to maintain alignment with international best practices in medical device standards to ensure the safety and efficacy of therapeutic goods. The objective of this order is to incorporate relevant international standards, such as those published by ISO, to ensure that medical devices are subject to the latest risk analysis and management methods. Compliance with these standards is voluntary, providing manufacturers with flexibility in demonstrating compliance with essential principles, while ensuring that Australian standards remain current and competitive in the global market. The enactment of MDSO (Biological Safety) 2008 was supported by key industry stakeholders and reflects the ongoing commitment to harmonise Australian medical device regulations with international standards. This approach aims to facilitate smoother regulatory compliance for importers and exporters, reducing potential costs and delays associated with non-compliance. The order was developed through extensive consultation with industry groups and was deemed non-regulatory, thus not requiring a Regulatory Impact Statement. As a legislative instrument, MDSO (Biological Safety) 2008 is subject to tabling and disallowance in Parliament, ensuring accountability and oversight in its implementation.

Scope and Application

The Medical Device Standards Order (Standards for Biological Safety of Medical Devices) 2008 applies to all medical devices intended for use in Australia, encompassing both those manufactured domestically and those imported into the country. This Order, established under section 41CB of the Therapeutic Goods Act 1989, specifies standards related to the biological safety of medical devices, ensuring they comply with essential principles that guarantee their quality, safety, and efficacy. The standards referenced in this Order include specific parts of ISO 10993 Biological evaluation of medical devices, which detail methods for biological risk analysis and management. Compliance with these standards is voluntary; however, if a medical device complies with the standards outlined in the Order, it is presumed to meet the corresponding essential principles. This presumption simplifies the process for manufacturers to demonstrate compliance with regulatory requirements. The Order's application extends across the entire Commonwealth of Australia, ensuring a consistent approach to medical device regulation throughout the country. There are no specific exclusions or exemptions mentioned in the Order; however, manufacturers have the option to demonstrate compliance through alternative means if they choose not to adhere to the specified standards.

Key Provisions

The Medical Device Standards Order (Standards for Biological Safety of Medical Devices) 2008 (MDSO (Biological Safety) 2008) is an instrument made under section 41CB of the Therapeutic Goods Act 1989 (the Act), which authorises the Minister, or her delegate, to determine medical device standards that are applicable to certain kinds of medical devices. This Order introduces standards relevant to the biological safety of medical devices to demonstrate compliance with essential principle 7.1(b) of the Act. The standards specified in MDSO (Biological Safety) 2008 are derived from Parts 1, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, and 18 of ISO 10993 Biological evaluation of medical devices. These standards set out methods for risk analysis and risk management, essential for ensuring that medical devices comply with the essential principles specified in the Act. The MDSO (Biological Safety) 2008 imposes certain obligations on parties or entities involved with the manufacture, import, supply, or export of medical devices. Manufacturers and other entities can choose to apply these standards to their medical devices, but this is voluntary. If a manufacturer decides to apply a medical device standard set out in the Order, and this is correctly applied to a device, the device is presumed to comply with the relevant parts of the essential principles (section 41BH of the Act). This presumption simplifies the compliance process for manufacturers, as compliance with these standards is one way to demonstrate adherence to the essential principles. There are no specific offences, penalties, or civil/criminal consequences outlined in the MDSO (Biological Safety) 2008 itself for non-compliance with these standards. However, the Therapeutic Goods Act 1989 contains provisions for regulatory action against manufacturers who fail to comply with the essential principles or other requirements of the Act. Failure to comply with the essential principles may result in actions such as the prohibition of the supply of the device, prosecution, or fines. The penalties for contravening the Act can vary depending on the nature and seriousness of the offence, and may include substantial fines or imprisonment. It is important for manufacturers to understand that while compliance with the standards in the MDSO (Biological Safety) 2008 is voluntary, non-compliance with the essential principles may still lead to regulatory consequences under the Act.

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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.