Registration of Medical Products
Registration of medical products is a state procedure intended to permit the launch of high-quality and safe products on the Russian market. Part 4, Article 38 of the Federal Law dated November 21, 2011, No. 323-FZ «On the Fundamentals of Public Health Protection in the Russian Federation» states that circulation of medical products registered in accordance with the procedure established by the Government of the Russian Federation, by the federal executive body authorized by the Government of the Russian Federation, shall be permitted in the territory of the Russian Federation. The Federal Service for the Supervision of Healthcare (Roszdravnadzor) is authorized registration body of medical products.
Medical products are any tools, apparatus, devices, equipment, materials and other products used individually or in combination for medical purposes, including together with other accessories, including special software, required to use these products for their intended purpose for the prevention, diagnosis, treatment of diseases, post-disease rehabilitation, health monitoring, medical research, restoration, replacement, modification of an organism's anatomical structure or physiological functions, pregnancy prevention or interruption, that do not achieve their functional purpose by the action of pharmacological, immunological, genetic or metabolic means on the human body.
The procedure of medical products registration consists of several stages
Stage I – Formation of a set of documents for import of medical products:
- Request for and receipt of initial documentation by the Contractor from the Customer, compilation of the Application;
- Selection of duly accredited laboratories to carry out technical trials, toxicological studies, Electromagnetic Compatibility testing (EMC testing) and clinical trials;
- Conclusion of Contracts between Testing Laboratories and the Customer;
- Obtaining import permission for import of medical products.
Stage II – Preparation of technical and operating documentation according to the requirements of the Federal Service for the Supervision of Healthcare (Roszdravnadzor):
- Analysis of the documentation received by the Contractor from the Customer for compliance with the requirements of Roszdravnadzor (review and correction of powers-of-attorney, request for missing information);
- Formation/Correction of the Extract from the Technical File subject to the requirements of Roszdravnadzor;
- Compilation/Correction of the Operator's Manual (Instructions for Use) subject to the requirements of Roszdravnadzor.
Stage III – Arrangement of activities for testing of medical products (technical trials, EMC testing, toxicological studies) and support of the registration process, including cooperation with Roszdravnadzor experts:
- Preparation and approval of the program of technical trials and toxicological studies in accordance with the Order of the Ministry of Healthcare of the Russian Federation No. 2n dated January 9, 2014;
- Arrangement of performing technical trials, EMC testing, toxicological studies;
- Evaluation of performed technical trials, EMC testing and toxicological studies for completeness;
- Preparation of information about regulatory documentation for medical products;
- Formation and submission of a set of documents to RF Roszdravnadzor for the first stage of the expert review. *
Stage IV – Arrangement and support of the clinical trial for a medical products:
- Preparation of information about the clinical use of medical products on the basis of clinical data provided by the manufacturer (clinical reports), and also assistance in the selection of research papers, publications, open statistical data, scientific reports and other documentation about the identical medical products;
- Arrangement of performing comparative studies of equivalent products, verification of data in accordance with the results of similar products' testing;
- Preparation and coordination with the clinical base of the program of clinical trials for medical products in accordance with the Order of the Ministry of Healthcare of Russia dated January 9, 2014, No. 2n;
- Arrangement of performing of clinical trials in the form of evaluation and analysis of clinical data, verification of clinical data of the clinical use of the products;
- Formation and submission of a set of documents to Roszdravnadzor to resume the process of registration and for the second stage of the expert review;
- Obtaining of the Registration Certificate.
* - For medical products of risk class 1, the results of clinical trials should be submitted for the 1st stage of the expert review
The list of documents for the state registration of medical products are being provided after the conclusion of the contract.
- Replacement of an old Registration Certificate form;
- Obtaining a duplicate of the Registration Certificate in case of its loss or damage;
- Introduction of amendments to the Registration Certificate and/or Medical Product Dossier (change of the Registration Certificate holder, manufacturing site, product name, etc.);
- Obtaining a Declaration of Conformity.
- Decree of the Government of the Russian Federation dated December 27, 2012 No. 1416 On Approval of the Rules 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 June 15, 2012 No. 7n On Approval of the Procedure for Import of Medical Products to the Territory of the Russian Federation for State Registration Purposes
- Order of the Ministry of Healthcare of the Russian Federation dated January 9, 2014 No. 2n On Approval of the Procedure for Medical Device Conformity Assessment in the Form of Technical Trials, Toxicological Studies and Clinical Trials for Medical Device State Registration Purposes
- Order of the Ministry of Healthcare of the Russian Federation dated January 19, 2017 No. 11n On Approval of the Requirements to the Contents of Technical and Operating Documentation of the Medical Device Manufacturer (Producer)
- Decree of the Government of the Russian Federation dated May 31, 2018 г. No. 633 On introducing amendments to the Rules for State Registration of Medical Device