At a sitting of the third session of the House of Representatives, MPs ratified a protocols introducing amendments to the Agreement on Uniform Principles and Rules for the Circulation of Medical Devices (medical products and medical equipment) within the Eurasian Economic Union (EAEU) of 23 December 2014, BelTA has learned.
The protocol on amending the said agreement, signed on 29 December 2025, provides for a two-year extension of the deadline for submitting applications for expert review or registration of medical devices in accordance with the procedures established by the legislation of the EAEU member states.
As Healthcare Minister Aleksandr Khodzhayev explained while presenting the draft law to the MPs, the circulation of medical devices within the EAEU member states, including Belarus, is permitted only after their registration. According to the Agreement on Uniform Principles and Rules for the Circulation of Medical Devices within the EAEU, as of 1 January 2026, the registration of medical devices was envisaged exclusively under the EAEU law.
However, given the need to ensure an adequate range of medical devices on the markets of the EAEU member states, the member states reached a consensus that the established timeframe was insufficient for transitioning to the registration of medical devices within the EAEU and fully abandoning national registration of medical devices.
“In this regard, in order to avert the threat of a shortage of medical devices registered in the EAEU member states, the parties signed a protocol that provides for extending the transition period until 31 December 2027, and preserves until 31 December 2028 the possibility of submitting applications for expert review and registration of medical devices under the procedures established by the legislation of the union’s member states,” said Aleksandr Khodzhayev.
According to him, the implementation of the protocol will ensure the continued circulation, until 31 December 2027, of medical devices registered under national legislation within the member states, as long as the registration documents remain valid. This will allow for a smoother transition to the registration of medical devices in accordance with the union’s legal acts and will ensure the availability of the usual range of medical devices for healthcare workers and the public.
The protocol on amending the agreement, signed on 9 February 2026, expands the list of medical devices not subject to registration within the EAEU. Specifically, medical devices manufactured according to individual patient orders exclusively for personal use are exempt from registration.
The protocol also adds to the cases where medical devices are not subject to registration within the union, namely: devices brought into the customs territory of the union for the provision of life-saving medical care to a patient with the authorization of a competent authority; medical devices manufactured on the territory of a member state for export; as well as kits, sets, packages, and first-aid kits assembled in accordance with the legislation of a member state from registered medical devices and medicines and intended for circulation within that state.
Thus, the ratification of the protocols will preserve a wide range of medical devices for use in medical practice in Belarus and harmonize the requirements for the registration of medical devices across the territory of the member states, the minister concluded.
