Skip to main content

Before being placed on market

 

 

Notification

 

The current national legislation prescribes, that the manufacturer or his authorized representative has to submit the statement to the State Agency of Medicines before putting on Latvian market class IIa, class IIb, class III medical devices, active implantable medical devices and IVD medical devices referred to in List A and List B, as well as medical devices for self-testing (notification procedure).

Manufacturer or his authorized representative has to send the completed statement form and copies of EC Declaration of Conformity and CE certificates (issued by a notify body) to the official e-mail address of the State Agency of Medicines info@zva.gov.lv. Received information will be included in the national database for medical devices.

The notification of class I, and other IVD medical devices is not mandatory.

There are no fees for notification and registering medical devices at the national medical devices database.

 

Language requirements

 

According to the Regulation No. 689 of the Cabinet of Ministers of the Republic of Latvia "Procedure for Registration, Assessment, Distribution, Exploitation and Technical Supervision of Medical Devices" adopted on 28 November 2017, information, which is available to the user and the patient so that the medical device can be used in accordance with the intended purpose, shall be in the official language.

The Official Language Law lies down that for any imported devices, the labelling, instructions for use, guarantee documents or technical certificate which includes information in a foreign language, shall have attached thereto a translation of such information in Latvian language. If a foreign language is used concurrently with Latvian language, the text in Latvian language shall be placed in primary position, and it may not, in its form or contents, be smaller or narrower than the text in the foreign language.