EXPLANATORY STATEMENT
Subject: MEDICAL DEVICE STANDARDS ORDER NO. 2 – Risk Management
Section 41CB, Therapeutic Goods Act 1989
OUTLINE
Medical Device Standards Order No. 2 – Risk Management (MDSO 2) 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 for the risk analysis and risk management methods concerning medical devices.
MDSO 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. MDSO 2 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, which set methods for risk analysis and risk management in order to demonstrate compliance of medical devices with the essential principles.
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
The Medical Device Standards Order No. 2 – Risk Management (MDSO 2) was enacted in 2003 under section 41CB of the Therapeutic Goods Act 1989. This legislative measure was introduced to address the need for a national system of controls that ensure the quality, safety, and efficacy of therapeutic goods used or exported from Australia. The Order was signed by the delegate of the Minister for Health and Ageing and came into effect upon its gazette. The primary policy objective of MDSO 2 is to specify relevant medical device standards, particularly focusing on risk analysis and risk management methods, to facilitate compliance with the essential principles. This compliance is voluntary, allowing manufacturers to use alternative means if they prefer, but adherence to the specified standards is recognised as a way to meet the essential principles outlined in the Act.
Scope and Application
The Medical Device Standards Order No. 2 – Risk Management (MDSO 2) applies to entities and individuals involved in the design, manufacture, import, supply, or distribution of medical devices within Australia. This Order, issued under Section 41CB of the Therapeutic Goods Act 1989, specifies the relevant standards for risk analysis and risk management of medical devices, although compliance with these standards is voluntary. Manufacturers and suppliers of medical devices can choose to adhere to these standards as one way to demonstrate compliance with the essential principles concerning the safety and performance of medical devices. If a medical device complies with the standards set out in MDSO 2 and is applied correctly, it is presumed to meet the relevant parts of the essential principles. The scope of this Order extends nationally, applying to all medical devices used or exported from Australia. While the application of these standards is voluntary, their adoption is encouraged to ensure the safety and efficacy of medical devices within the national system of controls.
Key Provisions
The Medical Device Standards Order No. 2 – Risk Management (MDSO 2) (section 41CB) outlines the specific standards for risk analysis and management of medical devices. This Order was established under the Therapeutic Goods Act 1989 and specifies the necessary methods for assessing and managing risks associated with medical devices. It was signed by the delegate of the Minister on 20 February 2003 and officially commenced on the day it was gazetted.
Under MDSO 2, medical device manufacturers must apply certain risk management methods to ensure that their devices meet the safety and performance requirements stipulated in the essential principles. These standards include detailed guidelines on how to conduct risk analysis and implement risk management strategies. By adhering to these standards, manufacturers can demonstrate that their devices comply with the essential principles, which are critical for the devices to be legally supplied, imported, or exported within Australia. However, it is important to note that compliance with these standards is voluntary, and manufacturers may choose to use alternative methods to demonstrate compliance, provided they meet the requirements of the essential principles.
The Order imposes certain obligations on medical device manufacturers. They must ensure that their products undergo a thorough risk analysis, identify potential hazards, and implement appropriate risk management strategies. These strategies should be systematically documented and reviewed regularly to ensure ongoing compliance with the essential principles. The manufacturers must also maintain records of the risk analysis and management processes, which may be required for review by regulatory authorities.
Breaching the requirements set out in MDSO 2 may have legal implications. Although compliance with the standards is voluntary, manufacturers must still adhere to the essential principles to ensure their devices are safe and effective. Failure to meet these principles could result in legal action, including potential fines and other penalties under the Therapeutic Goods Act 1989. The Act provides for enforcement actions against non-compliance, including the possibility of product recalls, injunctions, and criminal charges for serious breaches. The specific penalties for non-compliance with the essential principles are determined on a case-by-case basis, reflecting the severity of the breach and its impact on public health and safety.