Regulatory Guidelines for Medical Equipment in Australia
The medical equipment industry is amongst the most heavily regulated in Australia, and with good reason. Healthcare workers use any number of devices to diagnose and treat patients; these devices need to be of a certain standard to safeguard patient health and safety.
The Role of the TGA
The TGA — or Therapeutic Goods Association — plays an essential role in regulating the production and distribution of therapeutic goods in Australia. What is a therapeutic good? Simply put, it is any product that is used for the prevention, diagnosis, and treatment of a disease or injury.
The type of products that the TGA regulates therefore includes everything from herbal medicines to complex equipment used in a hospital setting.
The work of the TGA provides clinicians with full confidence that the products and equipment they are using to treat their patients work as intended and will not cause undue harm.
Overview of Medical Devices
One of the TGA’s main responsibilities is to monitor the development, product, and advertising of medical devices. The term ‘medical devices’ is all-encompassing, covering a wide variety of capital and consumable products.
To make this easier for equipment manufacturers and suppliers, the TGA has classified medical devices according to a range of criteria. This can be summarised as follows:
- Class I: Low risk, example being a bandage
- Class I — supplied sterile: Low-medium risk, example being a syringe
- Class I — incorporating measuring function: Low-medium risk, example being a measuring cup
- Class IIa: Low-medium risk, example being a thermometer
- Class IIb: Medium-high risk, example being a ventilator
- Class III: High risk, example being a joint replacement
- Active Implantable Medical Device: High risk, example being a defibrillator
The TGA provides a range of resources that are designed to assist companies that produce medical equipment in Australia meet their strict guidelines. They also play an active role in regulating these devices by providing both pre-market assessment and post-market assessment.
To be marketed and sold in Australia, all medical devices must be included on the Australian Register of Therapeutic Goods.
Paragon Care — An Experienced Provider of Quality, Approved Healthcare Products
As a leading provider of medical equipment in Australia, the team at Paragon Care possesses an in-depth, first-hand understanding regarding the importance of following TGA regulations. Our vision — to provide advanced solutions to improve patient experience and user workflows — demands that we supply our customers with equipment of the highest quality.
We understand that healthcare managers and clinicians hold a duty of care to their patients. In turn, we take our responsibilities towards our customers extremely seriously. Our product portfolio includes innovative capital and consumable products, supported by an extensive network of engineers across the Australia and New Zealand regions. Our values — which include integrity, transparency, accountability, teamwork, and a customer-focus — guide us in our quest to provide customers with quality healthcare equipment.
If you are looking for a supplier who understands regulatory guidelines and strives to provide customers with all the information they need to make an informed purchase, contact Paragon Care today.