Industrial Parks Association demands additional decrease of the terms of medical devices registration
The Industrial Parks Association asked the Ministry of Industry and Trade to accelerate the procedure of state registration of medical devices. The current facilitated procedure that has been implemented in April presumes reduction of terms of registration certificate receiving from 50 to 22 working days. It allows to enter the medical devices into the market faster and to prevent the risk of deficiency. The new scheme has the positive results and one device has already been registered according to the facilitated procedure.
However, the Industrial Parks Association supposes that this measure does not allow quick solving of the questions of accelerated import substitution and improvement of the situation in the market and in the sphere of healthcare for the procedure really reduces the registration cycle just for 10%.
The Association suggests the following:
To reduce the terms of development of operational and technical documentation for Russian-made medical devices by means of free access to the corresponding documentation of the manufacturers from unfriendly countries.
To allow trade of medical devices and their analogues produced according to the above mentioned documentation and supported with the temporary registration certificate and|or the Declaration of conformity in the period of trials and researches presumed by the Federal Service for Surveillance in Healthcare.
To issue the temporary registration certificate and to provide entry into the market for the devices registered in the EAEU for the period of state registration in the Russian Federation.
To implement the facilitated methods to reduce the terms of technical trials and toxicology research for there is a risk of overloading of trial laboratories and centers.
Not to perform clinical trials of the medical devices that have the registered analogue; to create the list of materials with proved biological safety not to perform some toxicology research as well.
The Industrial Parks Association is sure that such a solution will help to reduce significantly the terms of state registration on the practical level.