Tag Archives: biomedicalcellproducts

Introduction of changes in the registration dossier for biomedical cell products

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? –

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Import of biomedical cell product for the registration purposes

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

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Biomedical cell products quality indicators

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

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About biomedical cell product

Main information you should know about biomedical cell product in our great update: what is biomedical cell product by law? name of biomedical cell product – how to combine it how to store biomedical cell product (main questions from people who couldn’t understand how this “product” look like)? international regulation safety monitoring – what is the role of manufacturer and

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Nowadays the market for biomedical cell products (BMCP or BCP) is a rapidly growing branch of the global economy. This is due to the fact that this type of product provides a fundamentally new approach to the treatment of many diseases: malignant neoplasms, cardiovascular diseases, diseases of the nervous system and musculoskeletal system, as well as diabetes mellitus. BMCP is

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