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 the Order of importation of biomedical cell products (BMCP or BCP). The Order of import is still under consideration, but the main points have already been identified. How are samples of biomedical cell products imported? What documents are required to obtain an import permission? These and other questions will be discussed in this article.
- Who is allowed to import BMCP?
– Manufacturer BMCP,
– An organization with the rights to preclinical and clinical studies of BMCP, as well as to the technology of production of BMCP, or its authorized representative for the purpose of registration BMCP,
– Educational organizations that participate in the organization of pre-clinical and clinical studies,
– The aforementioned organizations for the cases of medical assistance to a particular patient, if there is a permit, which is an electronic document signed by an enhanced qualified electronic signature.
- List of documents required for obtaining sample import permission of a particular batch of BMCP, intended for its state registration.
– A statement containing the following information:
1) Information about the applicant (name and address of the applicant’s location, its main state registration number, TIN),
2) Information about BMCP (name of imported BMCP, name of organization (manufacturer) of BMCP, quantity of imported BMCP, country from which BMCP is imported, way of import and calendar date of prospective import of BMCP will be carried out).
– Certificate of the BMCP manufacturer, certifying compliance of imported BMCP to requirements of normative documentation on BMCP;
– Specification for BMCP.
- Terms and cost of issuing.
The Ministry of Health of the Russian Federation shall, within 10 working days from the date of receipt of documents, verify the completeness and reliability of the information contained therein and decide whether or not to issue a permission.
There is no charge for the issuance of permission.
We hope that an adequate and correct version of the Order will be approved in the near future and thus a further gap in the normative regulation of the BMCP circulation will be eliminated.
- FZ № 180 “On biomedical cell products”
- Draft of the Order of the Government of the Russian Federation “On approval of the procedure for importing biomedical cell products into the Russian Federation”