Medical devices and products have many advantages but need regulation for safe usage. The effectiveness of a device is determined by the regulatory laws set by the Australian Government’s health department for each class to ensure the product is safe for general use. Medical devices are available in different classes, depending on their characteristics and purpose.
What is a class 1 medical device? What are the products that fall into this category? What are the other classes for devices? Read on to learn more about the classifications of medical devices in Australia.
Class 1 medical devices are the ones that cause the least amount of harm for the user. Most devices in this class don’t need to abide by regulatory laws and are relatively safe to use. Roughly half the types of medical products fall into this category as they are simple in utility and functioning. They are subject to the least amount of regulation by the Therapeutic Goods Administration.
So, what is a class 1 medical device? Class 1 medical devices are considered to be very safe and require minimal authorization for usage. These non-invasive devices, which do not require piercing the skin, provide a high level of safety for users. Examples of Class 1 devices include gloves, masks, bandages, wraps and wheelchairs, among others, which can be used by consumers with confidence.
More than half the medical devices don’t fall into the first class. Here are the other categories of medical devices which are commonly used in the industry:
The TGA regulates the release of these products and performs examinations to prevent potential harm from medical devices. Unlike class I, these classes involve products that need greater monitoring to ensure no side effects.
Medical devices are divided into classes depending on the risk associated with the product’s intended usage and their invasiveness concerning their utility. Class I products carry minimal risk and require little compliance regulation.
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