Roszdravnadzor: the certification scheme for medical products hasn’t changed recently
Roszdravnadzor informs that the certification scheme for products in the Russian Federation is determined by Decree of the State Committee on Standardization of Russia of 21 September 1994 No.15.
The certification scheme for medicinal products hasn’t changed recently. According to explanatory statements of the Federal Accreditation Service (the letter of 26 February 2016 No.6344/04-SМ), a certification body may take, inter alia, the decision to reduce the number of tests as long as the established procedure of product certification is observed.
In addition, the Federal Accreditation Service has taken the decision to expand the area of accreditation of the test center of the Federal State-Funded Institution Scientific Center for Evaluation of Medical Products under the Ministry of Health of the Russian Federation.