Australia TGA Publishes Information on Manufacture of Medical Devices

The Therapeutic Goods Administration (TGA) Australia has published some information regarding the manufacture of medical devices pertaining to quality management in March 2022. 

Medical devices and in vitro diagnostic products (IVDs) are required to be safe for users and perform according to their intended uses. Medical devices need to comply with the Essential Principles, where it states that the manufacturer is responsible in demonstrating compliance of their products. 

The TGA has further elaborated about the general essential principles and design and construction essential principles. They also provided information on the conformity assessment of medical devices. 

More details can be found in “Manufacture of medical devices: Quality management, March 2022”:  

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