All medical devices for circulation on the territory of the Russian Federation are subject to compulsory registration with the Federal Service for Supervision of Health and Social Development (Roszdravnadzor). From January 1, 2013 registration of medical devices is carried out in accordance with the Decree of the Government of the Russian Federation No. 1416 of December 27, 2012.
The result of the registration of a medical device is the registration certificate of Roszdravnadzor.
Our specialists are ready to assist in the collection of all necessary documents, accompanying the review of documentation in instances, as well as in carrying out corrective measures, if necessary, to successfully obtain the registration certificate.
The registration certificate of the Federal Service for Supervision in the sphere of Health and Social Development is issued for medical equipment, tools and materials. The sale and use of medical devices in the Russian Federation without registration in Roszdravnadzor is prohibited.
The cost of registering of a medical device is calculated individually for each order, taking into account the product's risk class and accompanying documentation.
The list of documents for the registration of a medical device, in accordance with Government Decision No. 1416, is as follows:
- a copy of the document confirming the authority of the authorized representative of the manufacturer;
- information on the regulatory documentation for a medical device;
- technical documentation for the medical device;
- operational documentation for the medical device, including instructions for use or instruction manual for the medical device;
- photographic image of the general view of the medical device together with accessories necessary for the use of the medical device in accordance with the intended purpose (size should be not less than 18 x 24 centimeters);
- documents confirming the results of technical tests of the medical device;
- documents confirming the results of toxicological tests of a medical device, the use of which implies the contact with the human body;
- documents confirming the results of tests of a medical device for the purpose of approving the type of measuring instruments (with respect to medical devices related to measuring instruments in the field of state regulation of ensuring the uniformity of measurements, the list of which is approved by the Ministry of Health of the Russian Federation);
- List of documents;
- information confirming the clinical effectiveness and safety of medical devices (if available);
- Draft plan for clinical trials of a medical device with substantiating materials (if any).
Specialists of the "STM Group" LLC will provide you with the following services:
- Study and analysis of provided documentation on a medical product.
- Evaluation of the completeness of the document package and the correctness of registration of documents for the procedure of state registration of medical devices.
- Primary assessment of the purpose of the medical device.
- Determination of the type of medical device in accordance with the nomenclatural classification.
- Determination of the class of potential risk of using a medical device.
- Definition of the code of All-Russian classifier of medical devices.
- Consultation on the preparation of technical and operational documentation based on data submitted from the manufacturer, in accordance with the requirements of regulatory documents.
- Preparation and submission of a package of documents for state registration, approval of applications, tracking of the stages of registration (support of the registration process).
- Preparation of a document package for technical and toxicological tests (testing support).
- Preparation of a document package for clinical studies (research support).
- Submission of documents to Roszdravnadzor and receipt of the incoming number.
- Receipt of the issued registration certificate.
Using our services, it is possible to receive the registration certificate in 8-12 months. Immediately after receiving the registration certificate for the convenience of our customers at you can order and conduct certification of medical devices, medical equipment and products in EUROCERTIFICA Certification Body,.
We really value your time, therefore, to promptly resolve issues related to the registration of medical devices, you can send a Request to our specialists by filling in and sending an application to our e-mail address.