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Located in Australia - Therapeutic good - Medical devices
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How to determine if you are manufacturing a medical device
Medical devices are defined in the Therapeutic Goods Act 1989.
There are different requirements for manufacturers of medical devices. The TGA regulates medical devices under Chapter 4 of the Therapeutic Goods Act 1989 and all medical devices must comply with the Essential Principles. For more information, visit the Manufacturing medical devices: where to start webpage.
If you are still unsure whether your product is a medical device, you may wish to use the 'Is my product a therapeutic good?' decision tool to assist you in determining what type of therapeutic good you are manufacturing.
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Is the product a medical device as defined in the Therapeutic Goods Act 1989?
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