In order for the TGA to maintain public confidence in the safety, performance, benefits and risks associated with the use of medical devices on the Australian market, assessments may be conducted:
• before a device is able to be supplied to the market in Australia, and
• while a medical device is available on the market.
The TGA’s regulatory requirements vary, depending on what the device is and how it is to be used. The TGA is involved in most of the stages in the life cycle of a medical device. The team at De Groot Technical Services can assist in determining whether a product requires registration. Alternatively it may be possible to modify the product claims to overcome the need for registration.