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.
Apparently due to Indian regulations. I guess it cannot legally call itself a “hearing aid” without going through some kind of certification process.
Yeah the article mentioned that at some point. It still seems a bit petty to geofence it, instead of just calling it something else
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.