Contents
The registration of medical devices is a state-mandated process. Its objective is to guarantee the release of high-quality and safe medical devices on the domestic market of the Russian Federation. The registration of medical devices is conducted by the Federal Service for Surveillance in Healthcare (Roszdravnadzor) and is governed by the Rules for State Registration of Medical Devices approved by the RF Government Resolution dated December 27, 2012 No. 1416.
The following individuals are involved in the state registration process for medical devices in Roszdravnadzor:
- The applicant is typically the manufacturer of the medical device or its authorized representative (if the manufacturer is a foreign organization);
It is important to know!
In the event that a foreign medical device is subject to registration, the authorized representative is required to participate in the state registration process.
- Roszdravnadzor;
- The expert organization subordinate to Roszdravnadzor is the Federal State Budgetary Institution "National Institute of Quality" of Roszdravnadzor, also known as the Federal State Budgetary Institution "VNIIIMT" of Roszdravnadzor.
Prior to initiating the state registration process, it is essential to:
- Prepare the necessary technical, operational and other documentation as listed in the State Registration Rules. This documentation must then be checked for compliance with current regulations;
- Obtain permission to import a medical product into Russia (if the product is manufactured abroad) and import the required number of product samples for subsequent testing;
- Conduct the requisite toxicological and technical tests (in accordance with the characteristics of the medical device) in accredited testing laboratories. For medical devices classified as risk class 1, clinical trials must also be conducted;
- The mandatory stages of state registration of a medical device are contingent upon the risk class of the medical device in question.
The stages of state registration for devices classified as class 1 risk
- Receipt and registration of an application for state registration, with a complete package of required documents attached.
Verification of these documents by Roszdravnadzor specialists for completeness and accuracy.
- The decision making to initiate the process of state registration and to commission an examination of the quality, effectiveness and safety of a medical product.
- Expertise of the quality, efficacy and safety of a medical device in a subordinate expert institution of Roszdravnadzor.
- The evaluation of the expert institution’s conclusion is based on the results of the examination of the quality, effectiveness and safety of a medical device. Following this, a decision is made on the state registration of the medical device.
- Issuance of a registration certificate for a medical device to the applicant.
Stages of State Registration Devices of Risk Class 2a, 2b and 3
- Acceptance and registration of an application for state registration, with the full package of required documents attached. Inspection of these documents by specialists of Roszdravnadzor for completeness and accuracy.
- The decision on the commencement of state registration and the assignment for the examination of the quality, effectiveness and safety of a medical device shall be made;
- Expertise of the quality, efficiency and safety of a medical device performed in a subordinate expert institution of Roszdravnadzor,
- Receiving the examination results, its analysis will and a decision made regarding the issuance of permission to conduct clinical trials of the medical device in question,
- Issuance of clinical trial authorization to the applicant and suspension of state registration. You will find all the information you need on permissions for conducting clinical trials of medical devices on the Roszdravnadzor website.
- The applicant will conduct clinical trials of the medical device in an authorized clinical organization.
- Acceptance and registration of an application for renewal of state registration, with the attached results of clinical trials. Verification of these documents by Roszdravnadzor specialists for completeness and accuracy.
- Adoption of a decision on renewal of state registration of a medical device.
- Expertise of clinical trial results in a subordinate expert institution of Roszdravnadzor.
- Evaluation of the expert institution’s opinion on the results of expert examination of the quality, effectiveness and safety of a medical device and taking a decision on state registration of the medical device.
- Issuance of a registration certificate for a medical device to the applicant.
We can assist you with the registration of medical devices for sale in the Russian Federation. We will promptly collect and bring the full package of documents into compliance and submit an application to Roszdravnadzor on your behalf. We guarantee quality and a short processing time. Please do not hesitate to contact us by phone or submit an application for our services.