Aleksandr Khodzhayev
MINSK, 3 June (BelTA) – The procedure for registering medical devices under the EAEU program will be in high demand among manufacturers, Belarusian Healthcare Minister Aleksandr Khodzhayev expressed this confidence while responding to a question from MP Angelina Syromyatnikova after presenting the relevant draft law in the Oval Hall on 3 June, BelTA has learned.
The MP requested statistics on the registration of medical devices under both national legislation and EAEU legislation, as well as an outline of measures that could encourage medical device manufacturers to register their products more actively within the EAEU framework.
According to the minister, the state register currently contains over 22,400 medical devices of both foreign and Belarusian origin. Just over 5,300 of these are Belarusian medical devices. Belarus has 350 medical device manufacturers.
Regarding the registration of medical devices under the EAEU procedure, the minister noted that ongoing discussions are held not only with manufacturers but also with partner countries to encourage its use.
At the same time, Aleksandr Khodzhayev explained the nature of the simplified registration procedure currently applied in Belarus. “If a product is registered in an EAEU country, we understand the level and quality of that product and propose its supply to the country under a simplified scheme. This does not require additional testing or incurring financial costs,” he said.
“Unfortunately, this format has not yet been adopted within our union. However, I am confident that as discussions continue and the project begins to be implemented, the registration procedure under the EAEU program will be in high demand among our manufacturers,” said Aleksandr Khodzhayev.
As BelTA previously reported, the draft law on the Ratification of the Protocols Amending the Agreement on Uniform Principles and Rules for the Circulation of Medical Devices (Medical Products and Medical Equipment) within the Eurasian Economic Union of 23 December 2014 has passed its first reading.
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