Translated using machine translation service Hugo.lv
Submission of information on Latvian medical devices manufacturers and their manufactured MI for assessment and inclusion in databases
The selected organisation: Zāļu valsts aģentūra
Short description:
The State Agency of Medicines (ZVA) shall examine the information submitted by the manufacturer of Class I, in vitro diagnostic and order-manufactured medical devices (MI), as well as the processor of the MI (which bears the CE marking) systems or sets of procedures, the place of business of which has been registered in the Republic of Latvia, and shall enter the relevant information into the systems LATMED and EUDAMED
Beneficiaries:
Any person
Duration:
One month
Process description
Documents and forms
Other information
1. solis / Service requests
The submitter shall submit an application to the State Agency of Medicines and the necessary information
Payments: View payments
On the spot State Agency of Medicines
Adrese: Jersikas iela 15, Rīga, LV-1003
Phone number: 67078424
Fax: 67078428
Other contact details: Klientu apkalpošana 11. kabinets.
Working time
Mail State Agency of Medicines
Adrese: Jersikas iela 15, Rīga, LV-1003
Phone number: 67078424
Fax: 67078428
Other contact details:
Working time
2. solis / Receipt of services
The State Agency of Medicines shall enter the relevant information LATMED and EUDAMED within one month of receipt of the information.
The State Agency of Medicines shall inform the applicant in writing regarding the entering of the information in the databases.
Payments: View payments
Mail State Agency of Medicines
Adrese: Jersikas iela 15, Rīga, LV-1003
Phone number: 67078424
Fax: 67078428
Other contact details:
Working time
3. solis / A service charge
Procedures for Settlement

The fee for the commencement of the operation of a complete class I, in vitro diagnostic and order-manufactured medical device manufacturer, as well as a medical device (which bears the CE marking) system or a set of procedures (the place of business of which has been registered in the Republic of Latvia) and the inclusion of the relevant information LATMED and EUDAMED has been determined in conformity with the fees of the State Agency of Medicines for the service schedule (57 p.) - EUR 100,00.

When the service is provided, an invoice will be sent to the email address specified by the customer.
When you pay an invoice, you must specify the invoice number and date in the payment target.

Properties
State Agency of Medicines
Jersika Street 15, Riga LV-1003
Sales tax exempt. No. LV90001836181
The TREASURY
LV24TREL9290579005000
BIC TRELLV 22XXX
Payments: View payments