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Eurasian Medtech System Still 'Officially Targeting' 2021 Deadline

 
• By Ashley Yeo

The mood among various EAEU member states is that the deadline for system adoption should be extended beyond the end of 2021. So far, the authorities have not budged, though progress on system infrastructure continues to be made, according to local regulatory expert Alexey Stepanov.

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In spite of several proposals from Eurasian Economic Union member states, there is as yet no confirmed official position on an extension of the entry-into-force date of the Eurasian Economic Union’s (EAEU) harmonized regulatory system for medical devices. That, despite industry's position that there is not sufficient time for all five member states to have the necessary resources in place to implement the new rules ahead of the official deadline. Last year, at the Informa KNect 365 Medtech Summit, rumors were floated that there might be a 10-year extension ̶ but there has been no concrete update or response from the authorities.

Alexey Stepanov, a Moscow-based expert in regional medical device regulatory affairs, was a speaker at that meeting, and seemed at the time to sense industry’s pain in acknowledging that time...

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