Eurasian governments issue new harmonized medical device regulations

By Stewart Eisenhart, Emergo Group Governments of five Eurasian countries have issued final regulations to establish a harmonized regulatory system for medical devices and IVDs across their respective jurisdictions. As Emergo reported earlier in 2016, the governments of Russia, Kazakhstan, Belarus, Armenia and Kyrgyzstan signed on to a Eurasian Economic Union Agreement, but few additional details of the agreement as it pertained to medical device regulations were available until now. Emergo consultants in Russia as well as other sources now report that Eurasian Economic Union member states have issued more in-depth requirements for the regulatory system they intend to implement: Essential principles for safety, quality, performance and effectiveness of medical devices and IVDs based on guidance from the International Medical Device Regulators Forum (IMDRF)/Global Harmonization Task Force (GHTF) Common labeling requirements for devices and IVDs Guidelines for pre-submission testing and clinical trials IVDs will only require clinical trials, not technical testing Implantable devices will require full-scale clinical trials Setting up and maintaining a common medical device information system containing data on approved devices, accredited clinical testing centers and laboratories, and post-market surveillance data across all five Eurasian Economic Union markets A new Eurasian Economic Union medical device “mark” recognized by all five member countries Details o...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Blog Emergo Group Source Type: news

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