- 1- Вы задавались вопросами:
- 21. «Можно ли, внести изменения в РУ 2006 г.?»
- 22. «Требуется ли, переоформление РУ при смене организационной формы?»
- 23. «Как присвоить вид медицинского изделия в соответствии с Приказом № 4н от 06.06.2012 г.?
The utilization of medical products is regulated in strict compliance with regulatory documents within the Eurasian Economic Union (EEU) designed and approved for optimisation of processes in the area of utilization of medical products in territories of the EEU member states.
The EEU member states have to transit to the EEU standards in the area of utilization of medical products until December 31, 2021. After this period, all marketing authorisations will expires and all manufacturers (representatives) of medical products will have to pass all the stages of registration in accordance with rules and laws of EEU.
Due to the recent events, many of the EEU member states are thinking about possibility of elongation of the transition period. Some months ago, Russia informed that it was not sure that the manufacturing companies would be able to transfer to the new standards and requirements to medical equipment.
Quite uneasy situation has been established on the EEU market: it seems that it exists but in fact it doesn't. The fact is that the medical furniture, equipment and other medical products manufacturing companies have an opportunity to apply for registration in accordance with requirements of the union, but the registration itself is not performable yet. The main cause of this situation is unreadiness of informational system. Although it doesn't really influence business activities in this area yet, the term of the transition period has been reducing every day. A couple years ago, everyone thought that the specified period was enough, but now the members of the union think otherwise...
The main package of documents regulating all the processes in the area of medical products was approved more then a year ago. The market started working since May 6, 2017, but still not a single medical product has been registered under the new standards.
Due to lack of the informational system, the start of the new procedure of registration of medical products has been being constantly postponed in Russia and other countries of the union. First, it was planned to organise it for medical products and then, after testing, to apply it to medicines. But implementing the plans is still not possible as it's not easy to connect the 5 countries to the only regulated system of quality standards at once!
Necessity of the informational system is based on the fact that it's the key element of the process of registration of medical equipment. It is this system which allows to organise the fully-featured data exchange between the countries as well as submittal of electronic applications for registration within the EEU. Due to these events, many manufacturers of MP have different questions regarding this subject but the most pressing question is: will the manufacturers of medical equipment manage to timely transit to the new EEU rules? Now there are two possible ways out of this situation: either the period of validity of marketing authorisations for the medical equipment may be elongated or the transition period may be elongated.
But still the question of elongation of the EEU requirements transition period is not resolved. We can only discuss this situation and suppose. Unless there is any relevant official notice by any of the member states, the elongation of the period of transition to the new standards is not real. But still the date of expiration of the transition period is the same and all the manufacturers of the medical equipment should accomplish this transition before December 31, 2021.