28/04/2018
Sooner or later any manufacturer of medical products starts thinking about expanding his production and entering the foreign market. How to do it? Who to consult with? What documents are needed? Who will sell?
One of the most frequently asked questions from our clients is whether we are distributors.
And after receiving a negative response, the client starts searching for someone who is able sell his goods.
The process of finding a distributor, contractual obligations, signing a contract – all of this is worthy of a separate article, so we will skip it. At last the distribution contract is signed! We are ready to import goods and make profit! However, at this stage the manufacturer faces an unpleasant fact that the presence of a signed contract and the presence of a distributor does not allow him to import medical products into Russia. And the moment when he can make a profit is still very far.
The reason is that in order to import any medical products of any risk class into Russia it is necessary to receive the approval documentation, namely - Registration Certificate.
The procedure for obtaining the Registration Certificate lasts at least 5 months.
For technically complex products or high-risk products that pose a threat to human life, this period may reach 1.5 years. The timing and cost of each product registration depend on many factors, such as risk class, software availability, presence of electromagnetic compatibility, presence of pharmaceutical products, etc., so each registration is calculated individually.
The Registration Certificate can be ordered by the product manufacturer or any legal entity having a power of attorney drawn up in accordance with the established form from the manufacturer, which must be indicated in the application form for registration. In case of foreign production, only an authorized representative of a foreign manufacturer can obtain a registration certificate on the territory of the Russian Federation.
So, understanding the intricacies of Russian legislation and the nuances of registration of medical products, let's make two conclusions:
1. Finding a distributor is a very important and tedious business, because the professionalism of the distributor directly depends on how the manufacturer's product will be sold in Russia, but you do not need to postpone the start of registration until the moment you find the distributor. Because you may lose a lot of time, and lost time is a lost profit.
2. To obtain a registration certificate, the presence of a distributor is not necessary, but presence of an official representative in Russia is mandatory.
