I agree. Admittedly I haven't dealt with the legal side in years and never outside my own country. But definitely talk to a specialist lawyer or other expert about it. Because of the oral application it might not even be the lowest level of medical device anymore. And with that comes a multitude of regulations. From durability to material to production environment.
I like the idea and as someone who had to use a dispenser in my youth, I appreciate the smaller profile of it.