The official website of Roszdravnadzor has already published official information on the beginning of registration of medical products according to the rules of the EAEU, the laboratories are gradually re-accredited.
We decided to make a small extract from the new registration rules, which is radically different and you should learn about it.
For in vitro manufacturers, there are significant simplifications in registration, for example, you do not need to wait for permission to conduct clinical trials.
Now there will be mandatory inspections for the production if it is 2a sterile, 2b and 3 risk classes, in which case the registration is increased by at least 120 days.
The applicant in the right to choose the country of recognition and the dossier will be considered in all countries that he has chosen to sell his products. Also, production will have to implement ISO 13485 in the international certification system.
One code by type – one RU.
Thus, all RUs received under the old registration rules will be valid until 2021. More details can be found in the rules in the “Decision of the Council of the Eurasian Economic Commission of February 12, 2016 No. 46″ On Rules for Registration and Examination of Safety, Quality and Efficiency of Medical Devices. ”
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We will help with the implementation of the management system ISO 13485 in your production.
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