EXPLANATORY STATEMENT
Subject: MEDICAL DEVICE STANDARDS ORDER NO. 3 – Medical Devices Required to be Sterile
Section 41CB, Therapeutic Goods Act 1989
OUTLINE
Medical Device Standards Order No. 3 – Medical Devices Required to be Sterile (MDSO 3) 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).
This Order specifies relevant medical device standards relevant to medical devices that are required to be sterile, whether the device is to be sterilised by the manufacturer prior to release or to be supplied in a non-sterile state but packaged in such a way that it can be sterilised at a later stage following supply.
MDSO 3 was signed by the delegate of the Minister on 20 February 2003 and notified in the Commonwealth Gazette No. GN 9 on 5 march 2002. MDSO 3 commenced on the day 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 41CB of the Act provides the Minister, or the Minister’s delegate, with the power to determine medical device standards and to also determine that medical devices that comply with these standards are to be treated as complying with specified parts of the essential principles.
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, and this is applied correctly, the device is presumed to comply with the parts of the essential principles set out in the Order (section 41BH of the Act).
This Order determines medical device standards by reference to published standards in three areas: qualification of a device as "sterile", packaging, and validation of sterilisation processes. It is essential, as determined by the Order, that all three aspects are applied in combination for the final level of sterility to be achieved.
The requirements for devices that are to be supplied "sterile" are set out in Schedule 1 of the Order and the requirements for devices which are intended for sterilisation following supply are set out in Schedule 2 of the Order.
The validation of steam sterilisation procedures requires compliance with ISO 11134: 1994 or EN 554: 1994 and microbiological validation in accordance with AS EN 556.1-2002.
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.
Overview
Medical Device Standards Order No. 3 – Medical Devices Required to be Sterile (MDSO 3), enacted in 2003, was established under the Therapeutic Goods Act 1989 to address the need for stringent standards in the sterilisation of medical devices. This Order was created by the delegate of the Minister for Health and Ageing, as empowered by section 41CB of the Act, to ensure that medical devices are safe and effective for use. The primary objective of MDSO 3 is to specify the necessary medical device standards for ensuring sterility, whether the device is sterilised by the manufacturer or supplied in a non-sterile state for later sterilisation. This legislative instrument aims to provide a consistent and reliable framework for the qualification, packaging, and validation of sterilisation processes of medical devices, ensuring they meet the essential principles set forth in the Act.
Scope and Application
The Medical Device Standards Order No. 3 – Medical Devices Required to be Sterile, established under Section 41CB of the Therapeutic Goods Act 1989, applies to all medical devices that must be sterile, whether they are to be sterilised by the manufacturer before release or supplied in a non-sterile state with the ability to be sterilised post-supply. This Order applies nationally across Australia, ensuring that any medical devices meeting the criteria must adhere to specified standards to ensure their safety and efficacy. Compliance with these standards is voluntary, though it is a recognised means of demonstrating adherence to the essential principles outlined in the Act. The Order covers three main areas: the qualification of a device as "sterile", packaging, and the validation of sterilisation processes, with specific requirements detailed in Schedules 1 and 2 for devices to be supplied sterile and those intended for sterilisation post-supply, respectively. The Order does not impose any exclusions or exemptions but allows for alternative methods to demonstrate compliance with the essential principles, provided they meet the necessary safety and efficacy standards.
Key Provisions
The Medical Device Standards Order No. 3 (MDSO 3), under section 41CB of the Therapeutic Goods Act 1989, sets out the specific standards for medical devices that are required to be sterile (section 41CB(1)). These standards apply to devices intended to be sterilised by the manufacturer before release or those supplied in a non-sterile state but packaged to enable later sterilisation (Schedule 1 and Schedule 2). The Order references international standards such as ISO 11134:1994, EN 554:1994, and AS EN 556.1-2002 for the validation of sterilisation processes, ensuring that all aspects of sterility are addressed comprehensively (Schedule 1 and 2).
Entities governed by MDSO 3 must ensure that their medical devices meet the specified standards for sterility. This includes adhering to the requirements for qualification of a device as "sterile", packaging, and validation of sterilisation processes (Schedule 1 and 2). If a manufacturer opts to apply the medical device standards and complies with them correctly, the device is presumed to meet the essential principles outlined in the Order (section 41BH of the Act). Compliance with these standards is voluntary, but they provide a clear framework for demonstrating adherence to the essential principles of safety and performance for medical devices (section 41CB(1)).
Failure to comply with the standards outlined in MDSO 3 does not directly result in criminal or civil penalties within the Order itself. However, non-compliance may indirectly lead to regulatory action under the Therapeutic Goods Act 1989 if it results in a device that does not meet the essential principles, potentially leading to actions such as recalls, fines, or other regulatory sanctions as prescribed by the Act. The emphasis is on ensuring the safety and efficacy of medical devices through adherence to established standards rather than imposing direct penalties for non-compliance with the Order (section 41CB(1)).