Please refer to Section II of Russian Federation Decree 552 for details of this method of state registration. The list of medical devices is as follows:
- In the event of a shortage or risk of shortage, we will provide medical devices;
- Medical devices for which offers were received for the supply of devices at a price below the average market price;
- Other medical devices that are determined by the inter-departmental commission.
In order to obtain a registration certificate for these devices, it is necessary to prepare a package of documents that differs from those required for other registration methods.
The following section will provide further details on the specific documents required for each type of registration.
Documents Required for Registration:
- Statement;
- A copy of the power of attorney of the authorized person;
- A document attesting to the authority of the individual responsible for importing medical devices into the Russian Federation. Furthermore, the documents shall confirm that the devices belong to the authorized person;
- Technical documentation package;
- Package of operational documentation;
- Color photographs of the medical device with accessories (18x24 cm);
- The results of the tests (studies) conducted on the human body and organism, as well as the relevant conformity assessment documentation;
- Documents attesting to the results of tests conducted for the purpose of type approval of measuring instruments;
- Details of issued import permits or notifications;
- Documents confirming the possibility of carrying out device at the address specified in the application for state registration, copies of QMS certificates GOST ISO13485 (if available);
- Documents confirming quality, efficiency and safety;
- Detailed list of attached documents;
- For domestic devices, the applicant may choose to submit documents from the manufacturer or testing organization with the results and a list of the equipment used;
- In the case of foreign devices, the applicant may provide copies of documents confirming registration in the country of manufacture, accompanied by supporting documentation attesting to their effectiveness and safety.
Documents Drafted in a Language other than Russian Must be Accompanied by a Certified Translation into Russian.
Following the submission of the package of documents, Roszdravnadzor will undertake a review of the materials and information provided within the documentation, with a view to reaching a decision within 15 working days. Following this, a decision will be made and a conclusion issued as to whether or not registration of the medical device can be obtained.
In the event that the applicant has submitted an incomplete package of documents or lacks the necessary materials and information to enable an opinion to be formed, the documents shall be sent to the applicant in electronic form or by post within five working days of receipt. The applicant will be informed of any remarks and the method of their elimination in a detailed description.
The applicant is required to address the identified deficiencies within 30 working days. Following the response to the request, an expert opinion will be issued within five working days.
Please find Below the Reasons why we are Unable to Proceed with the Registration Process:
- There is no evidence that the medical devices comply with the requirements set out in the manufacturer’s documentation.
- The package of documents provided is incomplete and contains inaccurate information.
- There is no evidence of quality, effectiveness or safety.
- The risk of harm to health due to the use of the device exceeds its effectiveness.
- The medical device is not on the list.
A decision will be made within seven working days of receipt of the conclusion, either to register or to refuse the procedure. The applicant will then be sent a notification of the decision taken and confirmed by entry into the state register and issuance of the registration certificate, or a notification of refusal of the procedure with a detailed description of the reasons for the refusal.