EMERGO SUMMARY OF KEY POINTS:

• Russian regulators have extended a deadline to December 31, 2021 whereby medical device registration holders must replace valid certificates issued before 2013.
• “Old” registration certificate holders may legally sell their devices in Russia until the late 2021 deadline.
• Russia’s deadline extension aligns with efforts to establish harmonized medical device regulations across five countries under the Eurasian Economic Union agreement.

The Russian government has pushed back a deadline for replacing medical device registration licenses issued before 2013 to December 2021 in order to harmonize requirements under the Eurasian Economic Union Agreement.

According to Emergo sources in Moscow, Resolution #60 (link in Russian) officially extends the deadline whereby Roszdravnadzor medical device registrants must renew licenses issued prior to 2013; now, registrants have until December 31, 2021 to replace their certificates. Previously, Russian regulators had set a deadline of January 1, 2017 for replacing old registration certificates.

Now, medical device companies with registration certificates issued before 2013 and that have unlimited validity may continue selling in Russia until the 2021 deadline. The sooner firms apply for replacement of their registrations, however, the better to avoid delays and bottlenecks at Roszdravnadzor.

The deadline extension comes as Russia and other regional governments prepare to implement the Eurasian Economic Union, an agreement establishing regulatory harmonization including for medical devices across five Eurasian countries.

More information on Russia’s medical device registration requirements can be found in our whitepaper and regulatory process chart.