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For the production and distribution of medical products in the territory of the Russian Federation, these products should be registered by the Federal Service for Supervision in Public Health Care of the Russian Federation (Roszdravnadzor).
We perform the registration, amendments to the registration certificate as well as registration documentation of medical products of Russian and foreign production.
We have more than 10 years of experience in registration of certificates for medical products of Russian and foreign production in the territory of the Russian Federation.
The registration services will be supplied by one of the best experts in this field, possessing the highest degree of competence.
We will carry out the work for a reasonable remuneration, in the optimum time; we will also provide a flexible system of payments.
| Stage 1 |
Acceptance and registration of an application and documents for the medical product state registration, making a decision on the beginning of the medical product state registration;; |
| Stage 2 | Ordering the examination of quality, efficiency and safety of the medical products, analysis of its results and the decision to conduct clinical tests of the medical product; |
| Stage 3 | Renewal of the state registration of the medical product; |
| Stage 4 | Evaluation of the conclusion of an expert institution to determine compliance with the examination of quality, effectiveness and safety of the medical product and making a decision on the medical product state registration; |
The medical product registration certificates are issued by the Federal Service for Supervision in Public Health Care of the Russian Federation (Roszdravnadzor).
The registration is a state procedure designed to market only high-quality, effective and safe products. The registration certificate is a document confirming the safety and legality of the medical products on the market as established by the legislation of the Russian Federation. The registration is a prerequisite for the medical product's importation, use, sale, and production in the territory of the Russian Federation.
The registration certificate is valid indefinitely.
The state duty for the registration certificate is 7,000 rubles ($111). The state duty for the re-issuance of the certificate is 1,500 rubles ($23.8).
The amount of the state duty for conducting the quality, effectiveness and safety examination (depending on the class of potential risk of use in accordance with the nomenclature classification of the medical products) is the following:
Class 1 – 45,000 rubles ($713.25)
Class 2a – 65,000 rubles ($1,030.25)
Class 2b – 85,000 rubles ($1,347.25)
Class 3 – 115,000 rubles ($1,822.75)
Any instruments, apparatus, devices, equipment, materials and other products used for medical purposes separately or in combination with each other, as well as with other accessories necessary for using these products for the intended purpose, including special software, and intended for the prevention, diagnosis, treatment and medical rehabilitation of diseases, monitoring the state of the human body, conducting medical research, relief, replace, change the anatomical structure or physiological functions of the body, prevent or terminate pregnancy, the functional purpose of which is not realized by pharmacological, immunological, genetic or metabolic effects on the human body.
Medical products manufactured according to individual orders of patients, to which special requirements are imposed upon the appointment of medical workers and which are intended solely for personal use by a specific patient, are not subject to the state registration.
In accordance with section 4 of Article 38 of Federal Law N 323-ФЗ “On the Basics of Health Protection of Citizens in the Russian Federation” d/d November 21, 2011, the medical products that have been manufactured for further circulation shall be registered by the authorized federal executive body in the manner established by the Government of the Russian Federation.
The state registration procedure was approved by the Russian Government's Decree No. 1416 d/d December 27, 2012 “On Approval of the Regulations for State Registration of Medical Products”, as well as by Order No. 737n d/d of October 14, 2013 of the Ministry of Health of Russia
“Administrative Regulations of the Federal Service for Supervision of Public Health Care in the Provision of State Services for Medical Product State Registration”.