National registration of medical devices in EAEU can be prolonged for an unlimited period
Pandemic, risk of emergency situation and announcement of the state of martial law, as well as possible consequences of sanctions influence the procedure of registration of medical devices. The EAEU Council has decided that there is a need to extend the general rules of registration applicable in the EAEU countries and to add a possibility to transfer to national procedures. The technical control and accreditation department has already added the corresponding provisions and published them on the Union law database.
The flexible transition mechanism is developed for the cases of deficiency of medical devices being a result of sanctions imposed to any of the Union countries and for the cases of rapid registration of deficient items as a result of emergency situation. Registration according to the national rules allows to enter the goods to the market faster.
In the middle of June, it has been proclaimed that transition from the national rules to the general EAEU rules would completely finished in the end of 2022. In August, they informed on prolongation of the national procedure till 2025. Currently, both the statements are out-of-date and national registration can be unlimited until the international situation becomes stable.
Issuance of all the required documents and public discussions will take a month, namely, since the 5th of October to the 4th of November.