Medical Devices

Before a new medical device can be supplied to the market in Australia it needs to be assessed by the TGA (Therapeutic Goods Administration). The TGA’s regulatory requirements vary, depending on what the device is and how it is to be used.
Medical devices:
• are used on humans
• have therapeutic benefits
• generally have a physical or mechanical effect on the body or are used to measure or monitor functions of the body.
Medical devices range from a bandage that you would put on a scratch to high risk products such as pacemakers that are implanted in your body. Examples of medical devices include:
• artificial hips
• blood pressure monitors
• breast implants
• catheters
• condoms
• lubricating eyedrops
• MRI scanners
• Orthodontics - eg braces, fillings
• syringes
• tongue depressors.

In order for the TGA to maintain public confidence in the safety, performance, benefits and risks associated with the use of medical devices on the Australian market, assessments may be conducted:

• before a device is able to be supplied to the market in Australia, and
• while a medical device is available on the market.

The TGA’s regulatory requirements vary, depending on what the device is and how it is to be used. The TGA is involved in most of the stages in the life cycle of a medical device. The team at De Groot Technical Services can assist in determining whether a product requires registration. Alternatively it may be possible to modify the product claims to overcome the need for registration.