The current uniform requirements for registration of medical devices slow down the implementation of innovations and overload accreditation bodies. The discussion took place during a meeting of the Expert Council under the State Duma Committee on Industry and Trade, which occurred on February 1st. The meeting participants have reached a consensus to submit an appeal to the Ministry of Health and the Ministry of Industry and Trade, urging them to implement distinct registration requirements for medical devices of varying potential risk levels.
According Vladimir Gutenev, Chairman of the State Duma Committee on Industry and Trade, today it is necessary to quickly acquire technological sovereignty as part of the development of key industries for the country. He recalled that earlier the government approved a list of the first 10 megaprojects with an investment volume of at least 10 billion rubles for each important industry. “This includes the creation of domestic medicines and medical products,” Gutenev clarified.