Vastuskiri

Dear Kanyaw,

Indeed, I can help you with setting up the account.

Just to be sure, should I create the account in the database under your name? The account itself is personal (not for the company). The person then adds the company to the database and links themselves to it.

And yes, class I devices can be notified voluntarily, and if so, we do require a declaration of conformity, instructions for use, and a copy of the labeling as the short guide instructs.

Waiting for your reply.

Dear Karl,

thank you for your replay.

Yes, we would like to create an account, could you please help us?

I also found the guide for using the Estonian Medical Device Database and the requirements for product class I is this right?

Looking forward to your answer!

Best regards

Kanyaw Mahmood

Regulatory Affairs and Quality Control

ALLERGIKA Pharma GmbH

Hans-Urmiller-Ring 58

82515 Wolfratshausen

Tel.        0049 / 8171 - 42 25 - 896

Fax        0049 / 8171 - 42 25 - 850

E-Mail:   [email protected]

Statten Sie uns doch einen Besuch unter www.allergika.de ab.

Geschäftsführer: Stefan Lang (CEO), Dr. Michael Ernd

HRB 96295 Amtsgericht München

Allgemeine Datenschutzhinweise und Datenschutzhinweise für Pharmakovigilanz-Daten finden Sie bitte unter www.allergika.de/datenschutzhinweise/.

Sparen Sie Ressourcen – Ausdruck vermeiden, elektronisch archivieren.   

Dear Kanyaw,

Thank you for your inquiry.

As you mentioned that you wish to register your company's products in our database, I assume that it is to fulfill the medical device distribution notification requirement, which is based on Medical Device Act § 26 (4) and is worded as follows:

Every undertaking who distributes on the market of Estonia a system or procedure pack of medical devices according to Article 22 of Regulation (EU) 2017/745 of the European Parliament and of the Council or a class IIa, IIb or III medical device classified according to Regulation (EU) 2017/745 of the European Parliament and of the Council or Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices or Council Directive 93/42/EEC concerning medical devices or class B, C or D in vitro diagnostic medical devices classified according to Annex VIII of Regulation (EU) 2017/746 of the European Parliament and of the Council, shall notify the Health Board thereof within 10 days after distribution of the relevant medical device for the first time.

Notification about distribution can be completed through our national Medical Devices and Appliances Database, https://msa.sm.ee/eng.

For actors outside of Estonia, we can manually create an account, enabling login to the database with a username and password. To create an account, we need the contact person’s full name and email address. If you need an account, please let me know.

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

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 Madam,

I would like to contact you today with a request regarding the notification of medical devices.

My name is Kanyaw Mahmood I work for ALLERGIKA Pharma GmbH in Germany I am responsible for the regulatory affairs of our medical devices.

We would like to register our product in Estonia.

Can you please help us here?

Thank you and looking forward to your answer!

Best regards

Kanyaw Mahmood

Regulatory Affairs and Quality Control

ALLERGIKA Pharma GmbH

Hans-Urmiller-Ring 58

82515 Wolfratshausen

Tel.        0049 / 8171 - 42 25 - 896

Fax        0049 / 8171 - 42 25 - 850

E-Mail:   [email protected]

Statten Sie uns doch einen Besuch unter www.allergika.de ab.

Geschäftsführer: Stefan Lang (CEO), Dr. Michael Ernd

HRB 96295 Amtsgericht München

Allgemeine Datenschutzhinweise und Datenschutzhinweise für Pharmakovigilanz-Daten finden Sie bitte unter www.allergika.de/datenschutzhinweise/.

Sparen Sie Ressourcen – Ausdruck vermeiden, elektronisch archivieren.