- 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.?
For successful sales in the Russian market, it's necessary to obtain all relevant permits. Registration of new medical products in accordance with the regulations of the Russian legislation.
Production and sales of medical products may be successful only in case such activity fully complies with the Russian legislation in the field of utilization of medical products as the government strictly controls this area.
To avoid any responsibility, each manufacturer of medical products should familiarize itself with the Russian legislation regulating utilization of medical products .
If any supervision agency reveals any violations by the manufacturer, the latter will receive an order, as well as an audit report.
If the order is not complied with within the specified term, the violator may be held administratively liable.
Moreover, if any adverse reactions not specified in the user's manual or instruction for use occur during utilization of the medical product, the supervision agency should be notified about it.
In case of suppression or failure to submit facts about adverse reactions, new manifestations caused by interaction between medical products, as well as threat for human life and health, the legal actions specified by the Russian legislation may be taken against the violator.
If application of an unregistered medical product caused injury to a patient, those people who are responsible for it may be held disciplinary liable or even prosecuted.
Marketing Authorisation is the document which gives a right to 10 percent tax rate or even VAT exemption for sales of medical products.
Therefore, for successful business in the area of medical product utilization, it's necessary to comply with the Russian legislation, which includes obtainment of Marketing Authorisation. As its non-availability doesn't give any right to such fiscal benefits as VAT exemption or decreased 10 percent tax rate.