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.
Regulators in five Eurasian countries report progress in efforts to establish a harmonized medical device market that would incorporate Russia, Armenia, Belarus, Kazakhstan and Kyrgyzstan.
Political barriers to regulatory unification removed
According to Emergo and other sources in Moscow, a recent endorsement (link in Russian) by the Kyrgyz government of a protocol officially allowing Armenia to join the Eurasian Economic Union (EEU) has removed a key hindrance to implementing a unified medical device regulatory system for the region; that implementation now proceeds for all EEU members.
However, full implementation of uniform medical device regulations may still be some time away. EEU participating governments still must increase staff, facilities and funding in order to properly enforce registration and inspection requirements.
Quality management system inspection details released
One EEU member state, Kazakhstan, has also recently explained requirements (link in Russian) for quality system inspections necessary for medical device registration in the country and, presumably, other EEU member states.
Kazakh regulators state that quality system inspections are required for manufacturers that have not previously registered their devices in the country, as well as for manufacturers that cannot provide product samples to regulators for analysis prior to registration. Manufacturers must have valid ISO 13485 certification prior to undergoing inspections.
The caveat earlier in this post about regulatory resources, however, still stands. Across the EEU, it’s expected that between 250 and 300 qualified personnel will be needed to carry out a multinational quality system inspection regimen as described by Kazakh authorities.
Russia retaining its own regulations?
Although EEU member states have made significant progress toward implementing a uniform regulatory system, the Russian government appears intent on maintaining its own national system for overseeing medical devices, as well, at least for the foreseeable future.
Regulators at Roszdravnadzor (RZN) have recently issued draft amendments to Resolution 1416, which sets rules and requirements for medical device registration in Russia. RZN has proposed revising or overhauling the country’s device nomenclature classification system, as well as changing supplemental clinical data requirements. These actions suggest that RZN plans to continue a discrete regulatory path within Russia for medical devices.