The Belarusian government has simplified the procedure for state registration of medical devices. The resolution was signed by Prime Minister Aliaksandr Turchyn.
“The document was prepared in order to improve the procedure for state registration of medical devices, including its simplification for business entities, as well as to bring it into compliance with adopted legislative acts,” the government press service reported.
The overall period for the set of preliminary technical procedures preceding state registration has been reduced and will not exceed 90 calendar days, with the possibility of extension by agreement of the parties up to no more than 150 calendar days.
A specific list of preliminary technical procedures has been defined, and the Republican Unitary Enterprise “Center for Examinations and Tests in Healthcare,” which organizes their implementation, is prohibited from expanding it.
The procedure for clinical trials of low-risk (Class 1) medical devices has been simplified. The clinical evaluation of such devices may be carried out based on clinical data and evidence of equivalence to analogues previously registered in Belarus. This will make it possible to avoid conducting clinical trials for medical devices widely used in practical healthcare and to reduce manufacturers’ financial costs.
The document also уточняет сведения, включаемые в регистрационное удостоверение и Государственный реестр медицинских изделий.
