Registration of medical devices
In the Russian Federation, the Eurasian Economic Union, the European Union (CE marking)
Registration of medical devices is necessary and mandatory for manufacturers of medical products. The main objective of the registration procedure is to let into circulation only high-quality products which are safe for patients, so a number of tests are carried out during registration.
Independent registration of medical devices is a complex process. You need to comply with extensive legislation, which is also constantly changing.
Our specialists will take care of all the work on registering your product, with the consideration of all changes in the registration procedure.
Authorized representative of the foreign manufacturer in the Russian Federation
About the power of attorney issued by the manufacturer of the medical device to represent its interests
Preliminary consultation: how to register a medical device
Conducting an initial analysis of information on the medical device and its documentation. Drawing up a schedule for state registration. Updating the documentation.
Registration of medical devices according to the rules of the RF
Preparation of an application for state registration. Organization and support of all required tests at accredited laboratories. Preparation of the marketing authorization file. Submission of documents to Roszdravnadzor.
Registration of foreign medical devices in the Russian Federation
Preparation of a permit for the import of MD into the Russian Federation for the purpose of state registration. Preparation of an application for state registration. Preparation of the marketing authorization file. Organization and support of all required tests at accredited laboratories. Support for the MD registration at all stages.
Registration of medical devices according to the rules of the EAEU
Determination of the risk class, application and the type of MD in accordance with the nomenclature classification. Preparation of the marketing authorization file. Organization and support of all required tests at accredited laboratories. Selection of the reference state and the Member States concerned. Submission of the marketing authorization file to the registration authority. Assistance with passing the production inspection. Support for the MD registration process at all stages.
Registration of medical devices in the EU. Obtaining the CE marking
Classification of the product in accordance with the Global Medical Device Nomenclature (GMDN). Preparation of a technical file for the medical device. Submission of documents to notified bodies (NB). Assistance with passing the production inspection. Obtaining a CE certificate.