How does the government ensure the safety of medical devices?

In Plain English

The Australian government uses a system of rules and regulations to make sure medical devices are safe and work properly. Here's how it works:

  1. Defining Medical Devices: The Therapeutic Goods Act 1989 defines what counts as a "medical device". This can be anything from a simple bandage to complex software or implants.
  2. Essential Principles: Medical devices must meet certain "essential principles" to ensure they are safe and perform as expected.
  3. Medical Device Standards: The Medical Device Standards Order (Endotoxin Requirements for Medical Devices) 2018 specifies standards for certain medical devices, particularly regarding endotoxin contamination.
  4. Classification: Medical devices are classified based on their risk level. Higher-risk devices need more rigorous assessment.
  5. Conformity Assessment: Manufacturers must show their devices meet the required standards through a process called "conformity assessment". This can involve things like quality management system certification. The Therapeutic Goods (Conformity Assessment Standard for Quality Management Systems) Order 2019 provides standards for quality management systems.
  6. Registration: Most medical devices must be included in the Australian Register of Therapeutic Goods (ARTG) before they can be sold.
  7. Monitoring and Reporting: The government monitors medical devices after they are on the market. Healthcare facilities are required to report adverse events involving medical devices Therapeutic Goods Amendment (2022 Measures No. 1) Act 2023.
  8. Authorised Supply: In certain situations, health practitioners are authorised to supply medical devices that are not included in the Register Therapeutic Goods (Medical Devices—Authorised Supply) Rules 2022.
  9. Vaping Devices: Articles or components for use in the manufacture of therapeutic vaping devices or therapeutic vaping device accessories are specified to be medical devices and are therefore subject to the regulatory requirements Therapeutic Goods (Medical Devices—Specified Articles) Amendment (Vaping) Instrument 2023.

Detailed Explanation

The Australian regulatory framework for medical devices is established under the Therapeutic Goods Act 1989 and associated regulations. Key aspects of ensuring medical device safety include:

  1. Definition of Medical Device: Section 41BD of the Therapeutic Goods Act 1989 defines a "medical device" broadly, encompassing a wide range of articles intended for use in humans for various medical purposes. This definition is crucial as it determines which products are subject to the regulatory framework. The Secretary can also specify a particular class of instruments, apparatus, appliances, software, implants, reagents, materials or other articles for the purposes of paragraph 41BD(1)(ab) of the Therapeutic Goods Act 1989 Therapeutic Goods (Medical Devices—Specified Articles) Amendment Instrument 2025.
  2. Essential Principles: Medical devices must comply with the essential principles outlined in Schedule 1 to the Therapeutic Goods (Medical Devices) Regulations 2002. These principles cover aspects such as safety, performance, and labeling. Compliance with medical device standards can be treated as complying with the essential principles Therapeutic Goods Act 1989.
  3. Medical Device Standards Order: The Medical Device Standards Order (Endotoxin Requirements for Medical Devices) 2018 specifies a medical device standard for implantable medical devices and devices in contact with the cardiovascular system, lymphatic system, or cerebrospinal fluid, regarding endotoxin limits. Compliance with sections 6 and 7 of the Order means compliance with Clause 7.2 of the essential principles set out in Schedule 1 to the Therapeutic Goods (Medical Devices) Regulations 2002.
  4. Classification: Medical devices are classified based on their potential risk, as per Schedules 2 and 2A to the Therapeutic Goods (Medical Devices) Regulations 2002. Higher-risk devices undergo more stringent conformity assessment procedures. For example, software providing therapy can be classified from Class I to Class III depending on the potential harm Therapeutic Goods (Medical Devices) Regulations 2002.
  5. Conformity Assessment: Manufacturers must demonstrate that their devices meet the applicable standards and regulations through conformity assessment procedures, as detailed in Schedule 3 to the Therapeutic Goods (Medical Devices) Regulations 2002. This may involve quality management system certification. The Therapeutic Goods (Conformity Assessment Standard for Quality Management Systems) Order 2019 allows manufacturers to demonstrate compliance with conformity assessment procedures by complying with specified quality management system standards (e.g., ISO standards).
  6. Australian Register of Therapeutic Goods (ARTG): Most medical devices must be included in the ARTG before they can be supplied in Australia. This requires sponsors to certify that appropriate conformity assessment procedures have been applied Therapeutic Goods Act 1989.
  7. Post-market Monitoring: The TGA monitors the safety and performance of medical devices after they are released on the market. The Therapeutic Goods Amendment (2022 Measures No. 1) Act 2023 introduced mandatory reporting of adverse events involving reportable medical devices by healthcare facilities. Manufacturers are also required to systematically review experience gained in the post-production phase and implement corrective actions Therapeutic Goods (Medical Devices) Regulations 2002.
  8. Authorised Supply: The Therapeutic Goods (Medical Devices—Authorised Supply) Rules 2022 authorises certain health practitioners to supply medical devices not included in the Register to their patients under specific conditions, including informed consent and reporting of adverse events or defects.
  9. Vaping Devices: The Therapeutic Goods (Medical Devices—Specified Articles) Amendment (Vaping) Instrument 2023 specifies that articles or components for use in the manufacture of therapeutic vaping devices or therapeutic vaping device accessories are medical devices and are therefore subject to the regulatory requirements.

This multi-layered approach, encompassing pre-market assessment, manufacturing standards, and post-market surveillance, aims to ensure the safety and performance of medical devices available in Australia.