Medical Device Registration and Approval in Latvia

General country-specific regulatory information is provided on this page for medical device registration and approval in Latvia. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, including Latvia, to expedite the preparation of your medical device or IVD registration application.

Medical Device Regulations and Classification in Latvia

REGULATORY AUTHORITY: Devices are regulated by the EU list of Competent Authorities. In Latvia, devices are regulated by the State Agency of Medicines of Latvia (hereafter SAMLV).

CLASSIFICATION SYSTEM: Medical devices are classified according to risk into Classes I, IIa, IIb and III.

TIMEFRAME: The registration process takes about 4-6 weeks after submission for Class I devices. For the other classes, it depends on the contract with the notified body and the type of device.

LICENSE VALIDITY: Licenses issued in the EU are valid for five years. The registration certificate issued by the SAM does not expire.

AUTHORIZED REPRESENTATIVE: An authorized representative anywhere in the European Union is required.

ADDITIONAL INFORMATION: On April 5, 2017, two new Regulations on medical devices were adopted, these entered into force on May 25, 2017 and replaced the existing Directives. The new rules will only apply after a transitional period, namely, 3 years after entry into force for the Regulation on medical devices (spring 2020) and 5 years after entry into force (spring 2022) for the Regulation on in vitro diagnostic medical devices.

The current national legislation prescribes that the manufacturer or his authorized representative has to submit a statement to the State Agency of Medicines before a class IIa, IIb, and III medical device, active implantable medical device and IVD medical device referred to in List A and List B, as well as medical devices for self-testing (notification procedure) will be placed on the Latvian market. The notification of class I, and other IVD medical devices is not mandatory.

Last updated on October 22, 2018.

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