The регистрация медицинских изделийin Russia was amended in the year 2013. It was amended to comprise and bring a new course of action for medical device market approval. This new procedure was well organized, which made the Russian medical device clearer than earlier. The registration of medical devices can be broken down into six broad steps. Any interested foreign medical device manufacturer can consult the text of the Russian medical device regulation. The six broad steps are meant to provide an initial understanding and a framework of the Russian medical device regulations.
The first essential step in the регистрация медицинских изделий in Russia is finding the authorized representative. Foreign manufacturers have first to submit the registration. Roszdravnadzor regulates the market access and acts as surveillance for the Russian medical device market. The next step is technical and biocompatibility testing. A sample of the medical device must be sent by the manufacturer to be tested by an accredited laboratory in Russia. However, special importing permission has to be received from Roszdravnadzor to send the samples. The technical and biocompatibility tests are meant to determine the conformity of the device.
The third essential step during the регистрация медицинских изделийin Russia is compiling the technical documentation. The results from the technical and biocompatibility tests are gathered in the form of technical documentation. Thus, the manufacturer needs to make sure that their medical device's information is as complete as possible. In the fourth step, the Roszdravnadzor reviews the submission. Once the technical documentation is complete, it is sent to Roszdravnadzor to ensure the complete technical documentation. Roszdravnadzor also provides that the device contains all the pieces of information required to assess the device according to the regulatory requirements.
In the fifth step of the регистрация медицинских изделий, the third part reviews the submission. The third-party review is also commonly known as the expertise review. The third-party reviews the submissions' scientific, technical, and engineering information. This process is meant to check if the regulatory requirements for health and safety are met by the device or not. The final step is the clinical investigation or evaluation. The Roszdravnadzor performs the clinical evaluation in a hospital or clinical trial site. A medical device is fully approved only after clearing the clinical evaluation. Thus, the Russian medical device approval process has many actors and moving parts. If you are looking to enter the Russian market as a foreign medical device manufacturer, these six broad steps will help you build a strategic foundation.
