Kiri

Dear Stefanie,

We as a competent authority for medical devices are not aware of Bluetooth registration or related fees.

We recommend that you contact the party from whose website you obtained this information, i.e., [email protected].

The only thing I can say is that there are no fees to be paid for notifying the distribution of medical devices in Estonia.

Best regards,

Karl Kalev Türk

Chief Specialist

Department of Medical Devices

Phone +372 5648 5663

[email protected] | [email protected] 

This e-mail is confidential and meant for use by the person named in the letterhead. Any use in any way or copying of it by a person not marked as the addressee thereof is prohibited. If you have got this e-mail by mistake, please notify of it the sender without delay and delete the received e-mail together with all its attachments.

Dear Karl,

thank you for the fast reply and the information. According to the internet address you provided, I was able to find out that Bluetooth needs to be registered.

Can you please still tell me how much the notification costs and if there is an annual cost to maintain it or any other annual cost?

Thank you and kind regards

Dear Stefanie,

Thank you for your inquiry.

As I understand it from your question, you are already aware of the distribution notification requirement (Medical Devices Act § 26 (4)) in Estonia, which can be fulfilled through our national medical device database at https://msa.sm.ee/.

We are not aware of any additional notifications related to devices that use Bluetooth. However, we recommend that you confirm this information with the Estonian Consumer Protection and Technical Regulatory Authority, [email protected].

Please do not hesitate to contact me for further information or any questions.

Best regards,

Karl Kalev Türk

Chief Specialist

Department of Medical Devices

Phone +372 5648 5663

[email protected] | [email protected] 

This e-mail is confidential and meant for use by the person named in the letterhead. Any use in any way or copying of it by a person not marked as the addressee thereof is prohibited. If you have got this e-mail by mistake, please notify of it the sender without delay and delete the received e-mail together with all its attachments.

Dear Sir or Madame,

we have a medical device that we may want to sell in Estonia. For this we need to notify it according to your website.

This medical device works with Bluetooth. My question now is whether we also need to register Bluetooth? And if so, do you also know where or with whom?

Best regards