Regulatory Authority
State Health Care Accreditation Agency (VASPVT).
Classification
I, IIa, IIb, III
Quality system
ISO 13485:2016
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…).
Applicant
Authorized Representative or Manufacturer.
Timeframe and fees
Timeframe: 14 days.
There is a state fee for registering Class I devices, while for other risk classes, registration is free of charge.
Validity
Unlimited.
Labelling and documentation language
Labelling information must be submitted in Lithuanian, regardless of the level of competence of the end user.
Useful information
The State Health Care Accreditation Agency (VASPVT) website is constantly updated in Lithuanian.
Like all the Countries of the European Union, Lithuania will also adopt the New Regulation (EU) 2017/745 on Medical Devices. It is recalled that such Regulation, approved on April 5, 2017, is then entered into force on May 26, 2017. The full implementation of the New Regulation will take place on May 26, 2021.
