Registration of foreign medical products

Registration of medical products (MP) according to the national rules of the Russian Federation is the procedure necessary for legal sale and use of medical products in the territory of the Russian Federation.

The registration process consists of many stages, the result of which is the Registration Certificate (RC) – a document confirming the quality of MP and the legality of MP use in the territory of the Russian Federation.

The FEDERAL SERVICE FOR SURVEILLANCE IN HEALTHCARE (Roszdravnadzor) issues this document.

Medexpert employs experts specializing in documents preparation, who have 18 years of experience and knowledge in the field of preparing documents for the purpose of registration.

For foreign-manufactured medical products, the steps of the registration performance can be seen in the simplified strategy below.

 

The most difficult process in this strategy is the stage of documents preparation, because they shall comply with many regulatory documents.

When performing MP quality examination Roszdravnadzor relies on national quality standards (GOST R), international standards, as well as standards governing quality examination of medical products and the Registration Rules, here are some of the main documents:

  • Resolution of the Government of the Russian Federation dated December 27, 2012 No. 1416 “On Approval of the Rules for the State Registration of Medical Products”;
  • ORDER dated October 14, 2013 No. 737n “On approval of the Administrative Regulations of the Federal Service for Surveillance in Healthcare for the provision of state services for state registration of medical products”;
  • Order of the Ministry of Healthcare of the Russian Federation dated June 6, 2012 No. 4n “On approval of the nomenclature classification of medical products”;
  • Order of the Ministry of Healthcare of the Russian Federation dated December 21, 2012 No. 1353n “Procedure for quality, efficiency and safety examination of medical products” (with amendments by the Order of the Ministry of Healthcare of Russia as of June 3, 2015 No. 303n);
  • Order of the Ministry of Healthcare of the Russian Federation dated February 21, 2014 No. 81n “On approval of a List of measurements related to the state regulation of measurements uniformity ensuring performed while carrying out activities in healthcare, and mandatory metrological requirements for them, including accuracy measurement indicators”.

In addition to the submitted documentation, there is a huge layer of information obtained through the personal experience of our employees during RC registration.

The certificates issued based on advanced training and visits to seminars arranged by Roszdravnadzor and supervised expert organizations, and, most importantly, more than a thousand successfully implemented projects confirm the possession of relevant information by our experts.

For the registration of a foreign-manufactured medical product, our experts will help to form a unique dossier, based on which RC will be issued, which meets exactly your goals and requirements, because two identical Registration Certificates do not exist.

Use Calculator page to calculate the cost of our services when performing the registration.

To contact us, use Contacts page.