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.
