General country-specific regulatory information is provided on this page for medical device registration and approval in Lithuania.
We review our Regulatory Information frequently; please check back often for updates
REGULATORY AUTHORITY: Devices are regulated by the EU list of Competent Authorities. In Lithuania, devices are regulated by the Lithuanian State Health Care Accreditation Agency (VASPVT).
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.
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.
Manufacturers of class IIa, IIb and III medical devices and custom made active implantable medical devices have to notify the Accreditation Agency when these devices are placed on the market in Lithuania. Alternatively, their authorized representatives or their authorized distributors have to notify the Accreditation Agency.
Lithuanian manufacturers or authorized representatives who have registered place of business in Lithuania must notify Accreditation Agency about the first placing on the market of:
In addition – Manufacturers of medical devices of IIA, IIB and III class and custom made active implantable medical devices or their authorized representatives, or their authorized distributors have to notify Accreditation Agency when these devices are placed on the market in Lithuania.
For detailed device-specific compliance information for each market, including Lithuania, to expedite the preparation of your medical device or IVD registration application.
Did you know you can onboard your medical device or IVD compliance information to our system in less than 15 minutes?
And, in less than a minute, you can start your device-specific registration application and a complete county-specific registration process in this country or any of the other 140+ countries available for you through the Arazy Group Medtech registration platform.
