Registration of medical products in the Russian Federation

In accordance with Part 4 of Article 38 of Federal Law No. 323-FZ of 21.11.2011 "On the Fundamentals of Health Protection of Citizens in the Russian Federation", the circulation of medical products registered in the manner prescribed by the Government of the Russian Federation, a federal executive body authorized thereby, is permitted on the territory of the Russian Federation.

1. When registering a medical device - 2.3 months;
2. When making changes to the registration dossier of a medical device - 3, 4 months;
3. Accelerated examination of medical devices (re-registration) - 30 working days.

In the process of registration of a medical product, the manufacturer is required to submit to the authorized body a Registration Dossier containing information on the product, its intended use, technical characteristics and test results. The proper quality of documents and the absence of unreliable information therein ensures the smooth completion of this procedure in a minimum period of time, which is the purpose of our efforts. After the submission of the Registration Dossier to the Federal Service for Surveillance in Healthcare (Roszdravnadzor), we also keep supporting the client in the registration process up to the receipt of the registration certificate.

At the moment, it is possible to obtain registration of a medical product for the purpose of its circulation in the territory of the Russian Federation under the following provisions:

Our task

Entrusting the task of registering your medical device to us, you can be sure that we will ensure successful registration throughout the EAEU: in the Republic of Kazakhstan, in the Russian Federation, in the Republic of Belarus, in the Kyrgyz Republic and in the Republic of Armenia.

Electrontest LLP relies on many years of experience of its employees in registration of medical products within the Republic of Kazakhstan and the Russian Federation. We ensure a comprehensive approach to the registration procedure. If necessary, we, together with the testing centers of the Electrontest Group, ensure the full range of medical product testing: technical, toxicological, clinical and clinical-laboratory testing of In Vitro products.

You can save precious time and money by working with us, as we will undertake the preparation of all necessary documentation in accordance with the requirements of regulatory documents and regulatory bodies, as well as support the registration process after the submission of documents to the Federal Service for Surveillance in Healthcare (Roszdravnadzor).

Attention should be drawn to the fact that the registration process was significantly amended by the Resolution of the Government of the Russian Federation No. 552 of 01.04.2022, according to which the expertise of the application for state registration of a medical product and the documents submitted in accordance with the Rules of State Registration of Medical Products, as of the date of entry into force of this Resolution, shall be carried out simultaneously with the expertise of the completeness and results of the conducted technical testing, toxicological studies, clinical trials, and the results of the state registration of medical products, as well as tests for the purpose of type approval of measuring instruments (in respect of medical products related to measuring instruments in the field of state regulation of assurance of uniformity of measurements, the list of which is approved by the Ministry of Health of the Russian Federation), except for studies requiring clinical trials involving human participants.

This implies that the registration of all medical products, except those requiring clinical trials involving human participants, is carried out in a single stage. Obtaining clinical trial authorization is no longer required for most medical products. September 2022 The validity of Resolution of the Government of the Russian Federation No. 552 was extended until 01.01.2025. Thus, the procedure for one-stage registration of medical products on the territory of the Russian Federation will remain in force until 01.01.2025.

Stages of our work on the registration of medical products

1. Preparation of the Application and compilation of the Registration Dossier. Submission of a set of documents to the authorized body for subsequent registration.

As part of this stage, we will support you with the following:

• Preparation of the application for registration.
• Preparation of information on regulatory documentation.
• Preparation of manufacturer's technical documentation (technical file extract/technical specifications, risk management file, manufacturer's reports, qualification test reports).
• Preparation of operational documentation in accordance with the requirements.
• Submission of the medical product importation notification and implementation of the importation of samples.
• Organization of technical testing of medical products in our own testing laboratory "Electrontest", approval of documents confirming the results of technical testing of a medical product.
• Organization of toxicological studies of medical products in our own testing laboratory "ElectrontestBio" (if necessary), coordination of documents confirming the results of toxicological studies of a medical product.
• Organization of medical products testing for the purpose of type approval of measuring instruments (if necessary).
• Organization of clinical (clinical and laboratory) trials, preparation of documents confirming the clinical efficiency and safety of medical products.
• Formation of the Registration Dossier..

Astana, st. Anet baba, 9/3

+7 (776) 326 2500
+7 (702) 999 1964
+7 (701) 419 2225

Our work is based on a deep knowledge of regulatory documents, an understanding of the physics of processes in medical devices, the high qualification of our experts and, most importantly, on our own test base.

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_{For request:}
electrontest.kz@gmail.com