In a recent webinar, Priya Bhutani discussed significant updates to medical device regulations in the Eurasian Union, which includes Russia, Kazakhstan, Belarus, Armenia, and Kyrgyzstan. These changes will affect registration processes and submissions, particularly in Russia.

RegDesk, a regulatory software platform using AI for compliance, facilitates these processes by providing teams with regulatory intelligence and tools for managing applications efficiently.

Alexey Stepanov, a Regulatory Expert from Russia, provided insights on the evolving landscape. He explained that the Eurasian regulations aim to harmonize medical device approvals across member states, replacing the varied local systems. Key changes include mandatory quality management system inspections for high-risk devices and requirements for clinical trials to be conducted within the Eurasian Union.

The transition period for these new regulations is ongoing, with a critical deadline of January 1, 2022, when all new submissions must follow the Eurasian regulatory framework. Existing products will remain valid until their registration certificates expire, with a further extension for amendments until January 1, 2026.

Alexey emphasized that while Russia currently has the most complex approval process, other member states like Belarus may offer easier pathways. Manufacturers are encouraged to evaluate their target markets carefully to determine the best submission strategy.

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