Lithuania Medical Device Registration

Medical Device Registration in Lithuania: Requirements, Timeline

Updated on 26/01/24

Regulatory Authority: State Health Care Accreditation Agency

The State Accreditation Service for Health Care Activities under the Ministry of Health (VASPVT) was established in 1996 to accredit healthcare institutions and organize medical product approvals. Since 2003, VASPVT has expanded its functions to include licensing, accreditation, and laboratory certification of personal health care institutions.

It has also been responsible for conformity assessment of medical devices, market supervision, and patient safety. VASPVT has also organized evaluations of health care technologies, issued licenses for public health care activities, and participated in joint-international evaluations of medical devices. The service has launched various initiatives to combat illegal activities and improve the quality of healthcare services.

Link for Regulatory Authority: https://vaspvt.gov.lt/node/107

Local Regulation:Medical Devices Regulation

Classification:Class I, IIa, IIb and III

 Listing or Registration Requirements:

• In the case of a Non-European Manufacturer, it is necessary to appoint a European Authorized Representative.
• CE marking is normally required, except for custom-made devices, those intended for use in clinical investigations and IVDs intended for use in clinical assessments. All medical devices are subject to registration.
• For Class I DMs, prior registration is required with the Competent Authority of the Member State in which the Manufacturer is based.
• For Class IIa, IIb and III DMs, the Authorized Representative must notify the Lithuanian Authority of the placing on the market, including the required documentation (technical data, documents certifying the compliance of the devices with the requirements established by the various regulations, etc.).
• Registration required for Manufacturer/ AR based in Lithuania that places following devices (do it before placing it on market): Class I medical devices custom-made medical devicessystems and / or procedure kits devices that needs sterilization before usein vitro diagnostic medical devices
• Custom-made active implantable medicaldevices notification(within 14 days): by all persons who place Class II a, II b, III medical devices on the Lithuanian market, as well as custom-made active implantable medical devices

Documents Required:Registration form for medical devices (devices) placed on the market and submit the relevant documents specified in the form

Registration Timeline:

• Registration: 14-30 days
• Notification: 10 days

Registration Fee:

• Registration: 38 EUR
• Notification: Free

License Validity:Indefinite

Special Labelling Requirements:Labeling information must be submitted in Lithuanian, regardless of the level of competence of the end user

Additional Comments:

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 must notify the Accreditation Agency when these devices are placed on the market in Lithuania. Alternatively, their authorized representatives or their authorized distributors must 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:

• Class 1 medical devices
• Custom-made medical devices
• Procedure packs and systems (Article 12 of the Directive 93/42/EEC)
• In-vitro diagnostic medical devices
• Custom made active implantable medical devices
• 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 must notify Accreditation Agency when these devices are placed on the market in Lithuania.

Who should make this communication:

• Manufacturers
• Importers
• Distributors
• Authorized Representatives

When to make this communication: Before placing a medical device into the market.

Additional information:

On April 5, 2017, two new Regulations governing medical devices were adopted, coming into force on May 25, 2017, and replacing existing Directives. The application of these new rules is scheduled after specific transitional periods – 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, along with custom-made active implantable medical devices, are required to notify the Accreditation Agency when placing these devices on the market in Lithuania. Alternatively, authorized representatives or authorized distributors can fulfill this notification obligation on behalf of the manufacturers.

Lithuanian manufacturers or authorized representatives with registered places of business in Lithuania must notify the Accreditation Agency about the first placement on the market of:

• Class 1 medical devices
• Custom-made medical devices
• Procedure packs and systems (Article 12 of Directive 93/42/EEC)
• In-vitro diagnostic medical devices
• Custom-made active implantable medical devices

• Additionally, manufacturers of medical devices of IIA, IIB, and III class, and custom-made active implantable medical devices, or their authorized representatives, or authorized distributors, must notify the Accreditation Agency when placing these devices on the market in Lithuania.

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