Translated using Hugo.lv
Submission of information on authorised representatives of third-country medical devices manufacturers for assessment and inclusion of information in databases
Selected Organization: Zāļu valsts aģentūra
Brief description:
The State Agency of Medicines shall review the information submitted by a manufacturer of medical devices who does not have a registered place of business in any EU or EEA Member State, the appointed authorised representative, who has registered a place of commercial activity in the Republic of Latvia, and shall enter the relevant information in the Latvian Register of Medical Devices LATED and European Medical Devices Database EUDAMED
Beneficiaries:
Any person
Prior to placing a medical device on the market, the information shall be submitted to the State Agency of Medicines for examination by a manufacturer of medical devices who has not registered a place of business in any EU or EEA Member State, an authorised representative appointed who has registered a place of business in the Republic of Latvia
Period:
1 (one) month
Process description
Documents and forms
Other information
1. solis / Service Offices
The submitter shall submit to the State Agency of Medicines an application in which the information referred to in Paragraph 20 of Cabinet Regulation No. 689 of 28 November 2017, Procedures for Registration, Conformity Assessment, Distribution, Operation and Technical Supervision of Medical Devices, shall be indicated.

The service is free of charge.
Payments: View payments
An e-service in authorities home page Zva e-address
On the spot State Agency of Medicines
Adrese: Jersikas iela 15, Rīga, LV-1003
Tālrunis: 67078424
Fakss: 67078428
Other contact details: Klientu apkalpošana 11. kabinets.
Working hours
Mail State Agency of Medicines
Adrese: Jersikas iela 15, Rīga, LV-1003
Tālrunis: 67078424
Fakss: 67078428
Other contact details:
Working hours
2. solis / Receipt of services
The State Agency of Medicines shall enter the relevant information in the register OF Latvian medical devices LATED and European medical devices database EUDAMED WITHIN a reasonable time period, but not later than within one month from the notification of the service.

The State Agency of Medicines shall inform the applicant ZVA of the entering of the information in the databases by sending an electronic document signed with a secure electronic signature and containing a time stamp
Payments: View payments