Rezultat Audit Training Center
The procedure for registration of medical devices on the market of medical devices is undergoing a fundamental change. The change in the registration procedure under the Decree of the Government of the Russian Federation No. 1416 dated December 27, 2012 and the EAEU rules will, first of all, require a psychological realignment from medical device manufacturers, their representative offices in Russia, and consultancy organizations engaged in the preparation of documents for registration with Roszdravnadzor, due to the need to provide a large amount of manufacturer’s technical and operational documentation and quality management system documents and perform a large amount of testing to confirm the efficacy, biological safety and conformity of their products to the requirements of standards. The methodological approach to the preparation of a Dossier for the submission to Roszdravnadzor is based on the regulations that stipulate the procedure for the completion and submission of documents for the assessment of the quality and safety of medical devices, guidelines from the Expert Organizations, and the requirements of Roszdravnadzor for completeness and quality of submissions. The increased amount of documents to be submitted and higher requirements for the quality and scope of testing of medical device samples require that manufacturers’ staff members responsible for registration of medical devices have knowledge of regulations and are able to implement the requirements set by the Expert Organizations in practice, assess the completeness and quality of test results, and analyze the technical and operational documentation of the medical device manufacturers.
Rezultat Audit Training Center (License for Educational Activities No. 036176 dated May 8, 2015) provides refresher courses for specialists responsible for managing medical device registration in manufacturing companies and consulting companies specialized in medical device registration services.