Urgent registration process for Covid-19 tests is approved by Government
Order of Russian Government 430 from 03th of April 2020 was published yesterday (06th of April 2020), what is inside:
- list of products intended to be used in special conditions (emergency, martial law and so on). In this list – IVD test for COVID-19, thermometers, artificial ventilator apparatus;
- registration certificate is issued on the base on series/LOTs of medical devices/IVD products during 3 days by Roszdravnadzor;
- for some products there is no need to have registration certificate for sales – these are single use devices approved as medical device or IVD product in country of origin;
- this document in action before 01.01.2021.
Updates and full list of products will come soon.