GMP: OS Medical device? (8)

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, see 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.