Vastuskiri

Dear Darshna,

Thank you for your enquiry.

If the device is no longer manufactured and you are marked as a distributor, you can mark it as such (select the device from the database, then under "New procedure" there is a choice “Report discontinuation of manufacturing”).

If you are no longer a distributor of the device for whatever reasons it is possible to unlink the company from the device if you open the device profile and click green „end distribution“ button.

I must note that by the law there is no need to notify us about end of a distribution of a device.

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

karl.kalev.turk@terviseamet.ee | mso@terviseamet.ee 

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To Whom This May Concern

I would like to enquire if Medical Devices registered with the country would need notification from Regulatory if the Medical Device is ‘Out of Stock’.

If there is a process, please can this be shared, if there is no process can this be confirmed.

Kind Regards

Darshna Lad

Regulatory Speciaist – EMEA

External Free Lance Regulatory Affairs Specialist working for ResMed Regulatory Affairs group