Fast news about regulation

  • expected changes in taxes (government fees) for changing process – amendment process for technical dossier for issued registration certificates – this could cause possible changes in technical characteristics of medical devices.
  • no official information about prolongation of renewal process for registration certificates issued before 2013; manufacturers still need to change a form of registration certificate before January of 2017 as there is no any additional information from Roszdravnadzor and official laws that term became different.
  • about changing process and duplicates – Order of Russian Government 521n from 08.08.2016:
  1. Terms prolongation (government people work for changing process was 10 working days become 15, for duplicates was 3 working days become 7),
  2. Government fee for expertise process must be paid before documents submission to Roszdravnadzor (well-known fact but first official issue in law),
  3. Original of registration certificate is evidence of registration process (that’s why it is not enough to have registration certificate in electronic view even if information about your registration certificate in official Roszdravnadzor database,
  4. Second original of registration certificate will not be stored in Roszdravnadzor storage with registration dossier (as it was before). It could be the first step to electronic dossier.