Registration of foreign medical products in Russia
Before an international medical product appears on the Russian market, it must undergo a standard procedure established by the legislation of the Russian Federation. However, with insufficient knowledge of regulations and lack of experience in the design of customs documentation, you may face several difficulties. In this case, registration of medical products of international origin in Russia can last for an indefinite period and require significant financial investments.
“Quality” LLC offers professional services in the field of registration of this group of products. Having addressed to us, you can count on operative carrying out of all technical and toxicological researches and can receive competent legal support at all stages of the given procedure. Our specialists not only perfectly know Russian legislation, but also have solid experience of working with international partners, which allows them to solve the most difficult tasks at a high level.
With us, registration of medical products of imported production will become a simple and most effective process. We provide a range of services in this area, from testing medical equipment to documenting them.
In this article we will give detailed information on what is registration of medical products of foreign production, we will tell you how this process is carried out, and we will consider which documents should be submitted to Federal Service for Surveillance in Healthcare for issuing permission for import of medical products.
Registration of imported medical products
Registration of imported medical products in Russia is made on requirements like the registration of domestic medical products. This means that an obligatory condition for the delivery of medical equipment to the Russian market is the presence of a registration certificate of the established form. However, it is necessary to consider that the registration of medical products of imported production has its own specifics.
The rules for the importing medical products into the Russian Federation
The order of import of medical products to the territory of Russia for registration is established in accordance with the order of the Ministry of Health of the Russian Federation of 15.06.2012 No. 7n.
After obtaining permission to import medical products to Russia, the applicant has a one-time opportunity to bring the goods to the country, which must be used within six months from the date of issuance.
Such an authorization document is issued within 5 working days from the date of submission of the application and all necessary documentation.
To obtain permission to import medical products, you must submit the following documents to Federal Service for Surveillance in Healthcare of Russian Federation:
- An application signed by an entrepreneur, a management of a legal entity or other authorized persons acting on their behalf. It contains the following information: the name of the medical product, the date of its release, the expiration date, serial number, quantity, purpose of the product; name of the applicant, his legal address or residential address, passport data, requisites, etc.; information on the organizations in which toxicological, clinical and technical studies are expected to be carried out, etc.
- Copies of contracts necessary for the studies with the specification of the number of medical products;
- A copy of the authorization document, which gives the authorized person the right to perform his duties.
The subject of registration of imported medical products
According to the legislation of the Russian Federation, registration of international medical products is carried out by the manufacturer of the goods or by the company authorized by him, located in Russia.
If the distributor acts as an applicant, when presenting the documentation to Federal Service for Surveillance in Healthcare, he must have a power of attorney, which confirms his authority in the field of registration of a medical product on behalf of the manufacturer.
Rules for registration of international medical devices in Russia
This procedure has specific features that are directly related to the list of documents sent to the authorized body during the registration of foreign medical equipment. As for the cost of its conduct it is determined depending on the possible risks of use.
At the same time, an obligatory condition is the availability of documents from a foreign manufacturer guaranteeing high quality, efficiency and safety of products and received on the territory of their country. In addition, he must be an officially registered person.