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The regulation of medical devices

18 November 2011

The diversity of medical devices

Medical devices range from sticking plasters that would be put on a scratch, to high-risk products such as pacemakers that are implanted in the body. Other examples include artificial hips, blood pressure monitors, breast implants, catheters, condoms, contact lenses, MRI scanners, syringes and tongue depressors.

Many medical devices have a relatively short product lifecycle because they are being continually improved or replaced by newer products. As at 1 July 2011 there were approximately 36,000 entries for medical devices on the Australian Register of Therapeutic Goods (ARTG). A single ARTG entry can cover many individual medical devices and it is estimated that the ARTG may currently represent as many as one million distinct devices.

The risk-based regulation of medical devices

The TGA has a risk-based approach to regulation. It would be inefficient to regulate a tongue depressor with the same rigour as a pacemaker. The extent of regulation therefore depends on:

• the intended purpose of the device
• the degree of risk the device poses to the patient
• the degree of risk the device poses to the user and those in the vicinity
• whether the device is used internally or externally to the patient
• the duration of use.

The level of scrutiny by the TGA of a device before it is placed on the ARTG and supplied in Australia depends on the risk posed by the device. The TGA has adopted a classification system for devices, based on the level of risk. The lowest risk medical devices, Class 1 devices, are not assessed by the TGA prior to inclusion on the ARTG.

The TGA medical device classification system

Medical device classifications	Examples
Class I	elastic bandages, tongue depressors, cervical collars, slings, non-sterile dressings
Class IIa	X-ray films, intravenous tubing, contact lenses, catheters
Class IIb	Blood bags, dressings for severe wounds, condoms
Class III	Coronary artery probes, intrauterine contraceptive devices, medical devices that contain medicines, such as dressings with an anti-microbial agent
Active implantable medical devices	Pace makers, cochlear implants

Conformity assessment and ARTG inclusion

Conformity assessment is the procedure used to determine whether the safety, quality and performance of a device are adequate. Depending on the risk classification of a device, there are a number of different types of conformity assessment procedures that a manufacturer may select to use.

The manufacturer applies the conformity assessment procedure to generate evidence to demonstrate the safety, quality and performance of a device. Detailed information about conformity assessment and other aspects of medical device regulation is available in the Australian Regulatory Guidelines for Medical Devices.

Evidence that an appropriate conformity assessment procedure has been applied must be provided for all devices (other than class I devices that are not sterile or do not have a measuring function) prior to their inclusion on the ARTG.

A life-cycle approach to regulation

The TGA has a life-cycle approach to regulation. This means that for devices in lower risk categories there is a greater emphasis on regulation after inclusion on the ARTG, whereas for higher risk categories there is more extensive regulation prior to inclusion on the ARTG. Pre-market regulation consists of:

• the manufacturer applying appropriate conformity assessment procedures
• the manufacturer making an Australian Declaration of Conformity – a legal declaration that all the required evidence exists and that the device complies with Australian regulatory requirements
• the Australian sponsor submitting the manufacturer’s conformity assessment evidence to the TGA for all devices (except for class I devices that are not sterile or do not have a measuring function)
• the TGA evaluating the available evidence for high risk devices
• the device being included on the ARTG.

Post-market regulation consists of:

• the manufacturer maintaining current conformity assessment evidence to support the device
• the manufacturer monitoring ongoing performance and safety, and informing the TGA if there are any serious issues
• the TGA conducting both random and targeted assessments of medical devices included on the ARTG.

The role of health professionals

Health professionals use a wide range of medical devices in the course of their work. Unless a specific exemption applies, all medical devices supplied in Australia must be on the ARTG. Devices that health professionals use should be:

• supplied to the health professional by an Australian supplier, who should be able to confirm that the device is included on the ARTG; or
• imported by the health professional, in which case the health professional is the sponsor, and is responsible for lodging an application with the TGA and obtaining inclusion on the ARTG before the device is supplied or used.

The TGA does not regulate the practice of healthcare professionals. Members of the public may make a notification to the Australian Health Practitioner Regulation Agency about the conduct, health or performance of a registered practitioner or student practitioner.

Improvements to the regulatory framework

The TGA recognises that improvements can be made to the existing regulatory framework, and that reforming this framework is a process that will continue for many years. Described below are the first steps in this process.

Recommendations related to the regulation of medical devices were made by the Australian Government Health Technology Assessment Review. In response, the TGA released a discussion paper that contained nine distinct proposals for reform, and 77 submissions were received from stakeholders. The TGA has now considered the feedback received, and has modified its recommended reform proposals. A course of action has been proposed that involves progressing the implementation of the following:

• reclassifying hip, knee and shoulder joint replacements from Class IIb to Class III, with a two year transition period starting from 1 July 2012
• requiring medical devices to be named on the ARTG, with a two year transition period starting from 1 July 2012
• making more information available about medical devices supplied in Australia.

Future directions

Australia is a founding member of the Global Harmonisation Task Force (GHTF), a group of representatives from the medical device regulatory authorities and the regulated industry in Australia, Canada, the EU, Japan and the USA. The purpose of the GHTF has been to encourage convergence in regulatory practices related to:

• ensuring the safety and performance of medical devices
• promoting technological innovation
• facilitating international trade.

The GHTF in its current form is being disbanded and a new regulator-led international collaborative group will replace it. This new group will be able to discuss in detail the optimum ways to achieve harmonisation at an operational level. Australia will be taking an active role in the development of the revised regulatory forum.

Although the new forum will consist of regulators, input from stakeholders will play a vital role. The new forum will value input from all relevant stakeholders, including:

• consumers
• healthcare professionals
• academia
• industry

Reporting a problem with a medical device

The TGA's Incident Reporting and Investigation Scheme (IRIS) is used to manage all the reports received by the TGA of adverse events or problems associated with medical devices.

Anyone (patients, caregivers, health professionals, sponsors and manufacturers) can report a problem with a medical device.

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