Expected changes in Order of Russian Government 1416 (draft – august 2017)

Draft was prepared by Ministry of Health in Russia at 28.07.2017, there is no data of implementation for today. This is 4th version of order of Russian Government #1416 – and this is the biggest changes expected. main ideas:

  • Government could changes classification rules (4n code) – and in this case code will be changed automatically by informing holder
  • Permission of samples import – as a part of registration dossier
  • Changes in registration dossier caused Order of Russian Government 11n – manufacturer must provide information about drug or pharmaceutical components if medical device has
  • Fast track registration for IVD (the same as 1 risk class devices)
  • One (!) request for expertise stages
  • Relationship between FS and expert center (about expert conclusion)
  • Additional changing options: labeling, software versions, changing in accessorizes list and quantity.