MD regulation

Expected changes in Federal Law “On Principles of Healthcare for Citizens of the Russian Federation”

Draft document on amendments to the Federal Law “On Principles of Healthcare for Citizens of the Russian Federation” has been published.

Below we have listed what we believe to be the most essential extracts from this document:

  • it is permitted to sell medical products before expiry of their service life (shelf life), if they are manufactured within one hundred and eighty days after adoption of decision by the authorized federal executive body on amendment of documents included into the registration dossier for the medical product in accordance with information contained in the documents included into the registration dossier for the medical product before adoption of such decision;
  • manufacturer, authorized representative of the medical product manufacturer shall submit data on efficacy and safety of the medical product to the registration authority in the manner stipulated by the Government of the Russian Federation on an annual basis for three years upon state registration of the medical product (risk classes 2b and 3).
  • manufacturer, authorized representative of the manufacturer of medical products for in vitro diagnostics (potential risk classes 2b and 3) and disposable sterile medical products shall submit information on lots and/or batches of medical products introduced into civil trade turnover in the Russian Federation to the authorized federal executive body in the manner stipulated by the Government of the Russian Federation.
  • Safety of medical implants shall be monitored by maintaining registers of patients with medical implants. Procedure for maintaining register of patients with medical implants shall be determined by the authorized federal executive body.