- 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.?
As far as it's known, the activity of entities in the area of utilization of medical products should be carried out in strict compliance with the legislation of Russia. Otherwise, the illegal actions may cause to unwanted consequences like penalties and other sanctions and restrictions by the government.
The main task of the manufacturer of medical products is to posess the marketing authorisation for successful sales of the product in the market. But it still doesn't allow free and legal utilization of the registered medical product in the territory of our country. That's why there is another permit — the Declaration of conformity, which can be issued right after obtainment of the marketing authorisation.
The Declaration of conformity has a limited period of validity and is issued for 1 or 3 years
The Declaration of conformity is a permit confirming compliance of the medical product with the Russian state standards (GOSTs).
1) If you've registered your product with Roszdravnadzor and obtained the marketing authorisation, you have all the package of documentation required for issuance of the Declaration of conformity. In this case, it may be issued within just 5 business days. The cost is ₽44,000.
Our experts have been providing the permits issuance services for many years. For more detailed discussion of conditions of obtainment of the Declaration of conformity, you may contact us during working hours and find answers to all questions interesting for you.
– MA is ready but no Declaration?!
– 7 business days and everything is in place!