Hello everyone, how to understand the last item of Article 28 of the Medical Devices Registration Regulations Bureau Decree No. 16? (Registration as a whole device... Can be exempted from separate registration)
Take a simple example ah, for example, your whole machine is a cleaning system, there are dunnage, broom and robot ~ your intended use is cleaning, your combination form is robot + dunnage, robot + broom. You can sell this cleaning system or you can sell the robot + broom separately ...... That broom doesn't have to be registered separately ~ that's what it means.
We've had products integrated and then registered under the name of the system, but it's exceptionally hard to register~