- 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.?
There are frequent cases in the sphere of the state registration of medical products when it's necessary to form a Registration Denial Dossier. It always happens due to lack of experience!
But even if you've received a Denial of Registration, keep your head up! To prevent such cases in the future, it's necessary to resolve the most important question: how to register a medical product (on your own or employing the services of consulting companies)? The result of actions related to obtainment of such important permit as the marketing authorisation for a medical product depends on this basic question.
There are three types of applicants:
To avoid receiving the new Denial of Registration, it's necessary to do everything right with all solemnity and attention.
But if you've decided to carry out the registration process on your own, our recommendations will be helpful.
The Most Frequent Causes of Denials
Also sometimes the expert facility informs about impossibility to conduct clinical trials of the medical product or about negative conclusion of assessment results of which don't comply with specified parameters and standards.
If you've faced such situation and don't know what to do next, don't worry: Everything can always be made right!
It can take from 14 up to 30 days to form the Registration Denial Dossier. The cost of this service is calculated individually and depends on the scope of the violations described in the Registration Denial Notification as well as on the applicant's timeliness of submittal of additional materials
Knowledge possessed by our experts will help you to reach the desired result in time!