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.
The most typical causes of RZN Notifications
During the state registration procedure, some documents may expire (e.g., loan agreements, certificates for products and manufacturing). In such case, it's necessary to renew the expired documents
Also there are numerous cases when the information concerning product is submitted to the registering authority not in full. In this case, it's necessary to prepare amendments to all of the previously submitted materials and to submit them to the relevant authority
Sometimes 3 applicants are involved in the registration procedure (the manufacturer, the manufacturer's authorised representative and the legal entity for which the marketing authority may be issued) and they haven't filed the document on the parties' agreement for distribution of rights and liabilities. It is this document Roszdravnadzor may request.
After receiving the RZN Notification, those who have faced this situation for the first time may have the following questions:
Why does Roszdravnadzor address Notifications of discovered violations?!
What's wrong with the filed documentation?!
How the cause of mistakes can be identified?!
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!
What our specialists do in such situation:
They familiarize themselves with violations specified by the registering authority
They find the cause why this Notification had been sent
They analyse the documents which allows them to work out a plan of corrective actions
They bring the documents into compliance with the requirements of RZN
They conduct additional tests
They form the dossier of Corrective Actions
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!
1 Эксперт по внесению изменений в РД, дубликат РУ, замена РУ
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.?