- 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.?
Manufacturers of medical products often form dossiers for medical products on their own and submit them for registration in the relevant authority, then they receive Notifications of violation and don't know what to do next.
After you receive the Notification from RZN, you have to eliminate all mistakes within specified period (30–50 days, according to the regulations). Otherwise, your registration may be denied.
After receiving the RZN Notification, those who have faced this situation for the first time may have the following questions:
To eliminate the violations and to bring all the documents into compliance within the term specified by the legislation — that's the main goal after receiving the Notification from Roszdravnadzor!
For various reasons, the mistakes can not always be corrected within the specified timetable. If you are not sure you can solve this task on your own, you'd better consult professionals as the price of the mistake is your money and time!
It can take from 7 up to 30 days to form the dossier of Corrective Actions. The cost of this service is calculated individually and depends on the scope of the violations described in the Notification as well as on the applicant's timeliness of submittal of additional materials
If you've received the Notification of violation, it's not too late to correct everything!