Medical device registrations submitted to Russian medical device market regulator Roszdravnadzor now must adhere to new requirements, and applicants seeking registration under the previous rule must provide a written statement to the agency as soon as possible.
According to Emergo Group, medical device registration certificates obtained before 1 January 2013 will remain valid until their expiration dates. Registration certificates for devices approved prior to the new regulations that have no expiration date remain valid until 1 January 2014. At that point, manufacturers must submit official statements to Roszdravnadzor requesting replacement of registration certificates.
The medical device consulting group also noted the new regulatory system includes additional testing requirements for measuring devices. Emergo Group added it remains unclear whether regulators will require clinical testing for all risk classes or whether regulators will accept clinical test results from internationally accredited laboratories.
