Obtaining a medical product registration certificate

The registration certificate is an official document confirming that the medical product was listed in the State register and that it complies with the current requirements and standards. From 2012, registration certificates issued by Roszdravnadzor are valid for indefinitely. Obtaining a registration certificate is obligatory for the further use and sale of medicines or medical equipment. All products without a registration certificate are considered illegal, and their use is subject to sanctions under the Russian legislation. The following products require registration:

  • medical tools an equipment;
  • medicines;
  • pharmaceutical substances.

Stages and terms of issuing of a registration certificate

The procedure of obtaining of the registration certificate is specified in a number of legal requirements; it is rather complicated and lengthy. Below are the main stages of issuing of a registration certificate:

  • preparing a set of documents, drawing technical specification and getting the registration file ready — about 20 working days;
  • carrying out all required trials and tests — this stage may last from several weeks to several months depending on the product type and class;
  • consideration of the registration file by Roszdravnadzor, expert examination of the documents (up to 20 days) and clinical trials (delays to be specified);
  • issuing of the registration certificate.

Usually it takes 4-5 months to obtain a registration certificate from Roszdravnadzor. This is the minimal delay provided that qualified experts prepare the documents and assist the client at all stages of the registration process. Our experts are not only qualified, but they are also familiar with all the subtleties of the process of document drawing and examination.

The manufacturer may try obtaining the registration certificate on their own, without intermediaries. Anybody is entitled to do this.  However, you should be warned that in this case the registration certificate may be issued with a significant delay. This is primarily due to the mistakes committed when drawing and preparing the registration file that Roszdravnadzor may repeatedly return for corrections, as well as entirely refuse to register the medical product. For every try, you will have to pay the state duty again.

List of documents required for issuing a registration certificate

To register a medical product, you have to draw a number of documents stipulated by the Decree of the Government of Russia No. 1416 dated 27 December, 2012 and as later amended.

When the documents were drawn in a foreign language, they must be submitted accompanied by their duly certified Russian translations. If you happen to have any questions regarding the preparation of the set of required documents, our experts will be happy to clarify your doubts and to provide practical assistance.