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Saatja: 李诗兰 <[email protected]> Saaja: RA MSO Teema: Re: Vs: Consulting the procedure of registration of medical devices in Estonia Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada. Dear Piret, Thank you very much for your help. There is no any further question. Best Regards, Wendy Li Regulatory Affairs Bain Medical Equipment (Guangzhou) Co., Ltd. Tel: +86 020 66856868-290 Fax: 86-20-32067500 Email: [email protected] <mailto:[email protected]> Website:http://www.bainmedical.com/ RA MSO<[email protected]> 在 2025年4月23日 周三 18:46 写道： Dear Sir or Madam, The requirements for notification on distribution of medical devices in Estonia are briefly covered here: https://ravimiamet.ee/en/medical-devices/medical-devices/regulation-field-medical-devices-estonia Notification about distribution can be completed through our national Medical Devices and Appliances Database (EMDDB) https://msa.sm.ee/ and it is free of charge. For actors outside of Estonia we can make an account manually, so it is possible to log into the database with username and password. For creating an account we need a contact persons full name and e-mail. Please note that accounts in the database are personal (not for the company). I most cases, documents expected with the notifications of distribution of medical devices are the following: Declaration of conformity, EC certificate, instruction for use (original and in Estonian if required) and copy of the labelling or packaging. Also, have a look at the section on language requirements in Estonia: https://ravimiamet.ee/en/medical-devices/medical-devices/labelling-language-requirements Let us know if you have further questions or require an account for EMDDB. Best regards, Piret Põiklik Head of Department Department of Medical Devices State Agency of Medicines [email protected] <mailto:[email protected]> +372 5853 3610 1 Nooruse Street 50411 Tartu Estonia Phone: +372 737 4140 www.ravimiamet.ee <http://www.ravimiamet.ee/> This e-mail and any attachments transmitted may contain confidential and privileged information. If you are not the intended recipient, please notify the sender immediately by returning the e-mail and permanently deleting what you have recieved. Any dissemination or use of this information by a third person without permission is prohibited and may be illegal. Saatja: 李诗兰 <[email protected]> Saatmisaeg: kolmapäev, 23. aprill 2025 06:44 Adressaat: RA MSO <[email protected]> Teema: Consulting the procedure of registration of medical devices in Estonia Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada. Dear Sir or Madam, We are a Chinese manufacturer of medical devices ,which got CE marking. I'd like to know if it's necessary to register our products in State Agency of Medicines before placing them on the Estonian market. If it is necessary,please let me know the procedure of registration of medical devices(class I,IIa,IIb,III) in Estonia. Thank you very much for your time and assistance. Looking forward to your reply. Best Regards, Wendy Li Regulatory Affairs Bain Medical Equipment (Guangzhou) Co., Ltd. Tel: +86 020 66856868-290 Fax: 86-20-32067500 Email: [email protected] <mailto:[email protected]> Website:http://www.bainmedical.com/ <http://www.bainmedical.com/> 李诗兰<[email protected]> 在 2025年4月23日 周三 11:42 写道： Dear Sir or Madam, We are a Chinese manufacturer of medical devices ,which got CE marking. I'd like to know if it's necessary to register our products in State Agency of Medicines before placing them on the Estonian market. If it is necessary,please let me know the procedure of registration of medical devices(class I,IIa,IIb,III) in Estonia. Thank you very much for your time and assistance. Looking forward to your reply. Best Regards, Wendy Li Regulatory Affairs Bain Medical Equipment (Guangzhou) Co., Ltd. Tel: +86 020 66856868-290 Fax: 86-20-32067500 Email: [email protected] <mailto:[email protected]> Website:http://www.bainmedical.com/ <http://www.bainmedical.com/> Saatja: RA MSO </O=SOTSIAALMINISTEERIUM/OU=EXCHANGE ADMINISTRATIVE GROUP (FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=72F3C63240224E00B8EFA069E66B5C58-RA> Saaja: [email protected] Teema: Vs: Consulting the procedure of registration of medical devices in Estonia Dear Sir or Madam, The requirements for notification on distribution of medical devices in Estonia are briefly covered here: https://ravimiamet.ee/en/medical-devices/medical-devices/regulation-field-medical-devices-estonia Notification about distribution can be completed through our national Medical Devices and Appliances Database (EMDDB) https://msa.sm.ee/ and it is free of charge. For actors outside of Estonia we can make an account manually, so it is possible to log into the database with username and password. For creating an account we need a contact persons full name and e-mail. Please note that accounts in the database are personal (not for the company). I most cases, documents expected with the notifications of distribution of medical devices are the following: Declaration of conformity, EC certificate, instruction for use (original and in Estonian if required) and copy of the labelling or packaging. Also, have a look at the section on language requirements in Estonia: https://ravimiamet.ee/en/medical-devices/medical-devices/labelling-language-requirements Let us know if you have further questions or require an account for EMDDB. Best regards, Piret Põiklik Head of Department Department of Medical Devices State Agency of Medicines [email protected] <mailto:[email protected]> +372 5853 3610 1 Nooruse Street 50411 Tartu Estonia Phone: +372 737 4140 www.ravimiamet.ee <http://www.ravimiamet.ee/> This e-mail and any attachments transmitted may contain confidential and privileged information. If you are not the intended recipient, please notify the sender immediately by returning the e-mail and permanently deleting what you have recieved. Any dissemination or use of this information by a third person without permission is prohibited and may be illegal. Saatja: 李诗兰 <[email protected]> Saatmisaeg: kolmapäev, 23. aprill 2025 06:44 Adressaat: RA MSO <[email protected]> Teema: Consulting the procedure of registration of medical devices in Estonia Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada. Dear Sir or Madam, We are a Chinese manufacturer of medical devices ,which got CE marking. I'd like to know if it's necessary to register our products in State Agency of Medicines before placing them on the Estonian market. If it is necessary,please let me know the procedure of registration of medical devices(class I,IIa,IIb,III) in Estonia. Thank you very much for your time and assistance. Looking forward to your reply. Best Regards, Wendy Li Regulatory Affairs Bain Medical Equipment (Guangzhou) Co., Ltd. Tel: +86 020 66856868-290 Fax: 86-20-32067500 Email: [email protected] <mailto:[email protected]> Website:http://www.bainmedical.com/ <http://www.bainmedical.com/> 李诗兰<[email protected]> 在 2025年4月23日 周三 11:42 写道： Dear Sir or Madam, We are a Chinese manufacturer of medical devices ,which got CE marking. I'd like to know if it's necessary to register our products in State Agency of Medicines before placing them on the Estonian market. If it is necessary,please let me know the procedure of registration of medical devices(class I,IIa,IIb,III) in Estonia. Thank you very much for your time and assistance. Looking forward to your reply. Best Regards, Wendy Li Regulatory Affairs Bain Medical Equipment (Guangzhou) Co., Ltd. Tel: +86 020 66856868-290 Fax: 86-20-32067500 Email: [email protected] <mailto:[email protected]> Website:http://www.bainmedical.com/ <http://www.bainmedical.com/>