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.
In addition, Where the authorized representative has established a place of business in the Republic of Latvia, he shall provide the Agency with the notification information (as well as any changes to this information immediately) before the medical device is placed on the market.
The State Agency of Medicines shall receive and store information regarding manufacturers of medical devices having their commercial place of business in the Republic of Latvia and medical devices manufactured by them in accordance with the procedures prescribed by these Regulations; review and store information received in the medical device notification procedure and perform medical device vigilance.