Kiri

Saatja: Reg Efferon <[email protected]>
Saatmisaeg: neljapäev, 26. september 2024 17:42
Adressaat: Meditsiiniseadmed (Medical Devices) <[email protected]>
Teema: Re: Vs: Free sale certificate Efferon OÜ

Dear Karl,

Thank you мvery much for your detailed response and useful information!

We are just preparing to place our medical device on the market and would like to add our products to the Estonian Medical Device Database. However, the Efferon OÜ company belongs to an Austrian company and we do not have the opportunity to log into our personal account using an ID card, because none of our team has Estonian citizenship. In this regard, we would like to ask you for help in creating a personal account to add our devices to the database.

Thank you and have a nice day. 

Dear Veronika Titskaya ,

 

Thank you for your letter.

 

The Health Board issues a Free Sale Certificate for manufacturer or the authorised representative who has its registered place of business in Estonia.

 

For issuing the FSC we expect that all the devices that will be in the certificate are listed in the Estonian Medical Device Database (EMDDB) - https://msa.sm.ee/.

 

Application for a FSC must be made to [email protected] and it must include EMDDB codes, devices names, device models and risk classes. If the devices are compliant with MDR/IVDR then the basic UDI-DIs are also necessary.

 

There is also a state fee for issuing the Free Sale Certificate. The cost of the FSC depends on the selected processing time.

 

According to Estonian State Fees Act § 298², there are two type of fee for issuing FSCs.

(1) A state fee of 154 euros is paid for the issue of a certificate of free sale within 45 days after the submission of the application.

...

(3) A state fee of 308 euros is paid for the issue of a certificate of free sale within five working days after the submission of the application at the request of a person.

 

Payment information:

Beneficiary:                    Rahandusministeerium   Beneficiary's account ·        SEB Bank EE891010220034796011 (BIC/SWIFT: EEUHEE2X) ·        Swedbank EE932200221023778606 (BIC/SWIFT: HABAEE2X) ·        LHV Bank EE777700771003813400 (BIC/SWIFT: LHVBEE22) ·        Luminor Bank EE701700017001577198 (BIC/SWIFT: RIKOEE22)   Reference number: 2900083031 When paying the state fee please make sure you use the reference number.

 

The delivery costs within the range of Estonia are already included in the state fee.

After receiving the details and before issuing the FSC, we check if the information provided reflects the notified devices in the EMDDB.

 

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] 

 

Republic of Estonia Terviseamet | Health Board +372 794 3500 [email protected] www.terviseamet.ee Paldiski mnt 81, 10614 Tallinn Estonia

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.

 

 

 

 

Saatja: Reg Efferon <[email protected]>
Saatmisaeg: neljapäev, 26. september 2024 09:46
Adressaat: Meditsiiniseadmed (Medical Devices) <[email protected]>
Teema: Re: Free sale certificate Efferon OÜ

 

Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada.

 

Hello,

 

we would be grateful to receive your reply to my email below.

 

Have a good day!

 

-- 

Best regards,

Veronika Titskaya
Regulatory Affairs Specialist
Efferon OÜ
10613 Tallinn, Estonia
Mooni tn 18

Tõrge! Failinime pole määratud.

 

 

 

---- чт, 19 сент. 2024 11:10:05 +0300 пользователь Reg Efferon <[email protected]> написал ---

 

Hello,

 

my name is Veronika, I represent the Effron OÜ company. We are a manufacturer of a medical device and I would like to clarify the possibility of obtaining a free sale certificate.

 

Where should we apply to get this certificate? What documents will we need to provide in order to receive a free sale certificate?

 

We would greatly appreciate receiving your response and guidance on this matter.

 

Have a wonderful day!

 

-- 

Best regards,

Veronika Titskaya
Regulatory Affairs Specialist
Efferon OÜ
10613 Tallinn, Estonia
Mooni tn 18