Russia Blog Posts

Russian Regulators Amending Medical Device, IVD Registration Requirements

EMERGO SUMMARY OF KEY POINTS:

  • Russian regulatory changes for medical device and IVD registrants are slated to take effect by late 2017.
  • Roszdravnadzor (RZN) has proposed easing requirements for IVD registrations as well as certain changes to medical device registrations.
  • Medical device registration changes pertaining to technical documentation and user’s manuals, however, would require additional RZN review under the proposed changes.  
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Eurasian Medical Device Regulatory System Advances

EMERGO SUMMARY OF KEY POINTS:

  • All five members of the Eurasian Economic Union (Russia, Armenia, Belarus, Kazakhstan and Kyrgyzstan) are proceeding with full ratification and implementation of unified medical device regulations.
  • EEU members will have to devote more regulatory resources in order to fully implement their cross-border regulatory system.
  • Russian medical device regulators appear intent on keeping their own oversight system in place, at least over the near term.
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Russian Regulators Clarify Technical File Requirements for Medical Devices and IVDs

EMERGO SUMMARY OF KEY POINTS:

  • Russian regulators have finally issued official requirements for medical device and IVD technical file submissions.
  • The new rules mostly codify existing requirements that Roszdravnadzor had not previously made official.
  • Minor new rules regarding technical file and instructions for use contents have been included in the new order.
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Russian Regulators Extend Deadline for Replacing “Old” Medical Device Licenses

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.
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In Brief: Russian Regulators Expand List of Implantable Medical Devices

EMERGO SUMMARY OF KEY POINTS:

  • Russian medical device regulators have updated their list of products that qualify as implantable medical devices.
  • Roszdravnadzor has added 160 new devices to the list of implantables. 
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Eurasian Governments Issue New Harmonized Medical Device Regulations

Governments of five Eurasian countries have issued final regulations to establish a harmonized regulatory system for medical devices and IVDs across their respective jurisdictions.

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Eurasian Countries Agree to Harmonized Medical Device Framework

An agreement to establish a harmonized regulatory system for medical devices across Russia and several former Soviet bloc countries has been signed, but few details have thus far been released.

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Op Ed: Are Brazil, China and Russia making it Harder for Device Companies to enter their Markets?

Of the thousands of medical device manufacturers assisted by Emergo each year, most are based in North America, Europe and Japan, and will spend whatever it takes to enter those same markets. For most firms, markets such as the US, Canada, Europe and Japan offer the highest potential return on investment in terms of meeting regulatory requirements and commercializing their devices in those regions.

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Simplified Registration Pathway for Class I Medical Devices in Russia

Russian medical device market regulators have eased registration and market entry requirements for low-risk Class I devices, while at the same time formalizing procedures for certain registration amendments and changes to Instructions for Use (IFU).

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