| Dokumendiregister | Terviseamet |
| Viit | 11.1-2/24/11653-1 |
| Registreeritud | 13.11.2024 |
| Sünkroonitud | 14.11.2024 |
| Liik | Sissetulev dokument |
| Funktsioon | 11.1 Turustamise järgne järelevalve (post-marketing surveillance) |
| Sari | 11.1-2 Kirjavahetus Eesti turule lastavatest/kasutusele võetavatest/levitatavatest seadmetest MSA kaudu teavitamiseks |
| Toimik | 11.1-2/2023 |
| Juurdepääsupiirang | Avalik |
| Juurdepääsupiirang | |
| Adressaat | Southern Implants |
| Saabumis/saatmisviis | Southern Implants |
| Vastutaja | Karl Kalev Türk (TA, Peadirektori asetäitja (1) vastutusvaldkond, Meditsiiniseadmete osakond) |
| Originaal | Ava uues aknas |
From: Mathilde Mirotta <[email protected]>
Sent: Tue, 02 May 2023 09:20:05 +0000
To: "[email protected]" <[email protected]>
Subject: RE: Application for Medical Devices in the Interest of Public Health
Good day,
I hope you are well today,
I would like to remind you about this subject; indeed, we are still waiting for your answer in order to register your products in your country.
I thank you in advance.
Best regards,
Mathilde Mirotta
From: Mathilde Mirotta
Sent: Tuesday, April 25, 2023 1:26 PM
To: [email protected]
Subject: Application for Medical Devices in the Interest of Public Health
Good Day,
My name is Mathilde Mirotta and I write to you from South Africa, Southern Implants.
Southern Implants manufactures and distributes dental and facial implants worldwide, and we have been doing so, successfully for 35 years.
I work on medical device registration for Southern Implants.
I would like to know the medical device registration process for your country.
Where do I need to register my medical devices to be registered by the Ministry of Health? Or if I register my products on EUDAMED, is that enough ?
I thank you in advance.
Best regards,
Mathilde Mirotta

Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada.
| Nimi | K.p. | Δ | Viit | Tüüp | Org | Osapooled |
|---|---|---|---|---|---|---|
| Kiri | 13.11.2024 | 1 | 11.1-2/24/11653-5 | Sissetulev dokument | ta | Southern Implants |
| Kiri | 13.11.2024 | 1 | 11.1-2/24/11653-3 | Sissetulev dokument | ta | Southern Implants |
| Kiri | 13.11.2024 | 1 | 11.1-2/24/11653-2 | Väljaminev dokument | ta | Southern Implants |
| Kiri | 13.11.2024 | 1 | 11.1-2/24/11653-4 | Väljaminev dokument | ta | Southern Implants |