Last March 24 Ordinance No. N “On the requirements for the Contents of Technical and Operational Documentation to be provided by Medical Product Manufacturers” entered into force.
This ordinance defines officially for the first time the technical and operational documentation requirements that must be part of the medical device registration dossier at the Roszdravnadzor, the Russian Ministry of Health.
To date, these requirements were included only in voluntary measures, guidelines or non-binding standards, leaving many doubts about their interpretation and causing delays to paperwork management.
However, the ordinance is published only in Russian so it is hardly accessible to non-Russian manufacturers. In order to optimize time and costs, it is therefore necessary to rely on a reliable and competent partner in the territory who is aware of the new requirements.