Kiri

Dear Karl,

Hahaha, that was funny, thank you 😃

Ok, I will ask again, because maybe we want to sell it as non-medical product either, a so called “Wellness product”. I’ll run that track and see what their response is. Thanks for the tips 😊

Kind regards and a nice weekend

Stefanie

Dear Stefanie,

Estonia is such a small country that even if you write to another government authority, the letter will still end up on my desk.

Joke beside, please clarify that you are inquiring about whether Bluetooth devices/products need to be registered and if there are any fees associated with it, when addressing the Consumer Protection and Technical Regulatory Authority. If you mention medical devices to them, they will redirect the inquiry back to us. From your initial inquiry, I understood that you were asking if a device with Bluetooth needs to be additionally notified/registered because of the Bluetooth feature. Based on that, I wouldn't mention that the device itself is a medical device, as it's currently not relevant.

Best regards,

Karl Kalev Türk

Chief Specialist

Department of Medical Devices

Phone +372 5648 5663

[email protected] | [email protected] 

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Dear Sir or Madame,

we have a device that we may want to sell in Estland. It can be sold as medical and non-medical device and Bluetooth is also integrated in it.

Do we need to certify the device whether it is sold as medical or non-medical device?

Kind regards