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.  

The Russian government has indicated that it may loosen some rules for registration of medical devices and in vitro diagnostic products (IVDs) but also increase regulatory reviews of more substantial registration changes in the coming months.

Emergo consultants and sources in Moscow report that a new draft resolution (link in Russian) to amend Roszdravnadzor (RZN) registration requirements for devices and IVDs is currently under consideration at the Russian Ministry of Health, and must also be assessed by the Ministry of Economics; proposed changes could take effect by late 2017.

Simplified RZN registration for IVDs

First, the draft resolution proposes significant changes to Russian market authorization for IVDs. Specifically, IVDs would undergo premarket reviews consisting of a single assessment phase rather than the current two-stage review process. The draft resolution also indicates that clinical trial and technical testing components of IVD registration requirements will merge into a single process, thus easing Russian market access for IVD manufacturers.

Less onerous rules for some changes to medical device registrations

Second, the draft resolution would expand the list of changes to medical device certificates and dossiers that do not require an expert assessment; any changes that would not affect a device’s quality, safety or efficiency would fall under this new proposal.

Examples of changes for which expert assessments would no longer be required include changes to device trademarks; changes to versions of software; and changes to the number and/or names of accessories included with a registered device.

Labeling and/or packaging changes would also no longer require expert assessments, according to the draft resolution.

But…increased scrutiny of more substantial registration changes

While RZN has proposed increasing the types of changes to device registrations that would qualify for a simplified review process, the regulator would also increase requirements for other types of changes. The draft resolution would require full reviews by RZN as well as expertise centers of any changes to a registered device’s technical documentation or user’s manual.

Related Russian regulatory information from Emergo:

• Russian RZN registration support for medical device and IVD companies
• Russia Authorized Representative in-country representation
• Whitepaper: RZN medical device registration
• Video overview: Russia’s medical device approval process