- 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.?
Before starting importing medical products and starting the production process, all businessmen should familiarize themselves with the list of products they are planning to use on the territory of Russia. That's the situation when it's necessary to request samples of products to check their compliance with quality, safety, and efficiency requirements. All above mentioned actions are intended for achievement of the same goal — obtainment of the marketing authorisation for a medical product, as well as other mandatory permits.
Many manufacturers often have various questions:
Samples are the medical products imported for carrying out special tests with them. The main task in this situation is to show the customs authorities that the samples you're going to import won't be utilized in the territory of Russia unless all required permits are issued.
The procedure of import of medical products is regulated by Order of the Ministry of Health of Russia No. 7n dated 06/15/2012.
The Russian legislation strictly controls import of medical products in Russia. That's why you should thoroughly prepare to the procedure of issuance of permits for your products if you've decided to register a medical product for further sales on the Russian markets. As it's necessary to issue and sign all relevant documents, copies of contracts and other documents the Customs service may require before import.
The cost of this service is ₽50,000.
You have no right to import the prohibited medical products listed in the uniform list of EEU
Moreover, while importing the samples, you may be asked to submit the contract of carrying out of tests, the statement of tests, protocols and acts of tests, confirmation of legitimacy of import of the samples, and so on. In other words, the authorities have right to request all the previously executed documents required for import of the samples of medical products.
Hence, to use the new medical product on the territory of Russia, it's necessary to make a lot of efforts. As the legislation specifies strict procedure of import of samples, one wrong action or mistake may sufficiently complicate all the process of the state registration of a medical product.
If necessary, you may get more detailed consultation concerning obtainment of the Samples Import Permit , without which you can't get through customs and perform all required tests or research of your medical product.
If you have intention to obtain the Permit — Call us!