I can actually forgive this one. A lot of medical devices regulations require that if you function as something or make it available, then you need to pass the certification for offering it.
You can’t just relabel a device as something else if you clearly intend for it to be used as a medical device. Shady Bob’s emergency electrical heart massager isn’t going to fly.

In the US, hearing aids required a prescription until 2022. What I can glean from translated sites is that India still has that requirement.