Changing in Regulation for medical devices – the biggest from 2013

Amendments for Order of Russian Government 1416 were done – and this 4th issue is the most significant from 2013 year.

Main ideas:

  • IVD registration uses fast track for 1 risk class devices
  • 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 but from country of origin
  • One (!) request for expertise stages
  • Relationship between FS and expert center (about expert conclusion)
  • Additional changing options: labeling, changing in accessorizes list and quantity.

Wait our big review soon – how it works and what to expect from Order of Russian Government 633 from 31.05.2018.