Medical Device
Belsyme has expertise in the registration of new and maintance of the existing Medical Devices in Australia and New Zealand. We can help you navigate the Australian Therapeutic Goods Authority (TGA) and Medsafe's:
Benefit vs Risk Regulatory Approach
Classification of Medical Devices
Understand Sponsor and Manufacturers Responsibility
Electronic submission process
Australian specific documentation and labeling requirements
If you would like more information on any of our services please feel free to contact us.