The Russian government has introduced a temporary permitting procedure for the import into the Russian Federation of biomedical cell products (BMCP). The relevant decree of the Government of the Russian Federation of 16.10.2018 No. 1229 was signed by Prime Minister Dmitry Medvedev. Permission for temporary admission will be valid from November 1, 2018 to April 30, 2019 and will apply

  Clinical investigations (CIs) of biomedical cell products (Biomedical cell products) are an integral part of the registration process. CIs are conducted on the basis of the permission to conduct CI of BMCP, issued on the basis of the results of the first stage of the expertise in the expert center of the Ministry of Health of the Russian Federation.

In the section “Biomedical cell products” of our web site there were published a lot of articles, devoted to the analysis of normative documentation and scientific articles related directly or indirectly to the registration of BMCP. This article is devoted to the process of making amendments in the registration dossier for the already registered BMCP. What can be changed? –

In late May, the Government of the Russian Federation approved regulation 633 “On amendments to the Rules of State registration of medical devices”, according to which the registration dossier should now include sample import permission, which certainly affected the process of registration of medical devices. (More on the link). The beginning of the summer was also marked by news concerning

Currently, there is data on the development and patenting of more than 700 biomedical cell products (BMСP) for the treatment and prevention of various diseases. Of course, each of them should be an effective and high-quality product. According to the definition of FZ 180 “On Biomedical Cell Products” Quality of biomedical cell product is the correspondence of biomedical cell product to