In accordance with Russian Federation legislation, all medical devices, irrespective of their level of risk, must be registered for legal circulation within the country.
In line with Decree No. 552 dated 01.04.2022, new registration rules for low-risk medical devices have been introduced in response to the introduction of restrictive economic measures against the Russian Federation. These measures are designed to eliminate the possibility of defects or the risk of defects in these devices. The list of these devices includes medical overall, masks, breathing apparatus, gloves, shoe covers, and so forth.
This document outlines a streamlined approach to the registration process for medical devices. The Decree has introduced a single-stage registration procedure for all medical devices, which we hope will prove beneficial.
Stages of the Registration Process
At the initial stage, the necessary package of documents is collected. Verification is carried out by representatives of Roszdravnadzor. If the submitted documentation is found to be authentic and complete, a temporary registration certificate for the medical device will be issued within five business days. The certificate is a legal document that allows the sale of medical devices within the Russian Federation, both wholesale and retail. The certificate is valid for a period of 150 days. During this period of time, it would be advisable to organize and conduct all the necessary tests, the results of which you then provide to the authorized bodies. Once the results have been reviewed and a positive decision has been made, you will receive an unlimited registration certificate from Roszdravnadzor for the medical device.
Please advise as to which documentation is required for simplified registration?
The registration of medical devices included in the list is conducted in an accelerated manner. In order to obtain a registration certificate, applicants are required to provide the following package of documents:
- Statement;
- 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 medical devices belong to the authorized person;
- A copy of the power of attorney of the authorized person;
- Package of technical documents;
- Operational documentation;
- Color photographs of the medical device with accessories (18x24 cm), and also, if available, photographs of the electronic media and interface for software with the same characteristics;
- A detailed list of the attached documents indicating the relevant section in Resolution No. 552, in accordance with which the registration is expected to take place.
- Documents drafted in a language other than Russian shall be accompanied by a certified translation into the latter.
Provided all the necessary documentation is submitted correctly, a registration certificate for a low-risk medical device can be issued within five days. Should the documentation be returned to you for revision, you are required to complete the necessary updates and amendments within five days. Please note that although the registration certificate for a medical device is issued for a period of 150 days, the form does not indicate the validity period of the registration certificate. Once a temporary registration document for a medical device has been issued, it is the responsibility of the applicant to conduct all necessary tests to confirm that the device complies with the required standards. Please generate a new registration dossier and submit it to the registration authority along with the original Roszdravnadzor registration certificate.
Let us examine the documentation in greater detail to verify the information provided for the registration of a medical device. The application is completed in accordance with the prescribed format, as outlined in the Annex to the Decree. The information provided in the application shall be supported by the submission of a specified set of documents:
- A copy of the power of attorney to the authorized representative of the manufacturer;
- Information on the regulatory documentation of the medical device;
- In case of changes based on the results of tests (study) of a medical device:
- 1. Technical documentation.
- 2. Operational documentation.
- 3. Color photographs of the medical device with accessories (18x24 cm).
- Documents attesting to the outcome of tests (research) including, if applicable, the results of medical devices for the purpose of type approval;
- Copies of documents confirming the quality of substances used in the device of the medical device or included in its composition and intended for use only in accordance with the purpose of the medical device;
- Original of registration certificate;
- Detailed description of the attached documents.
In the event that the applicant is an authorized representative of the manufacturer, a power of attorney confirming the legality of these powers is required. It is essential to include the following details in this power of attorney:
- Full details of the person for whom the Roszdravnadzor certificate will be issued;
- Date of execution of the power of attorney and its validity period.
What should the Technical Documentation for a Medical Device contain?
- Its full name and other information (model number, design options, etc.) that will allow identification of the device;
- Detailed description of the purpose and operating principle of the medical device;
- List of indications and contraindications for the medical device;
- Description of potential consumers (who it is intended for and where it can be used);
- Description of the main functional elements of the medical device (diagrams, photographs, drawings, charts and other explanations);
- Description of components (if any);
- Description of accessories and devices including medical ones, intended for joint use;
- Detailed information about which materials of the device are in direct contact with the body;
- Description of possible risks of application, as well as methods of management and reduction;
- Information on verification and validation of a medical device to prove compliance including results:
- 1. Testing in laboratories.
- 2. Tests simulating operational ones.
- 3. Animal testing.
- List of materials of animal and/or human origin used with a detailed description (if available);
- Links to previous or similar modifications of the medical device;
- Description of the main stages of design (diagrams, photographs, drawings, charts and other explanations);
- Information on sterilization and on validation methods for sterilization, including validation of the packaging process (for devices supplied sterile);
- Information on the process of development and validation of software used in the finished medical device;
- Requirements for technical maintenance and repair work;
- Information on disposal and destruction.
Simplified registration of medical devices: how quickly is it done?
The accelerated registration of medical devices is a process whereby a registration is issued without the need to conduct a number of studies and expert examinations. Following the granting of permission for registration within 150 days, the aforementioned procedures may be carried out, resulting in the confirmation of registration for the medical device in question.
Please be advised that if the documents are not provided in full, they will not be accepted and Roszdravnadzor will return them to the applicant.
Following the receipt of the registration certificate, the applicant is required to provide samples of the medical device for testing and research purposes within five days. This is to approve the type of measuring instrument and to settle the costs incurred for the services provided.
The tests will be carried out in accordance with the standard program within 50 working days. Subsequently, the following steps will be taken:
- Issuance of relevant documents that confirm the results of the tests (study) performed;
- Submission to the registration authority of documents that confirm the results of the tests (research) passed. In addition, a letter is attached indicating information about the establishment or non-establishment of facts and circumstances that pose a threat to the life and health of people during use and operation;
Reasons for the Conclusion on Impossibility of State Registration:
- There is no evidence that the medical device meets the requirements of the manufacturer’s documentation;
- There is currently no evidence available to assess the quality, effectiveness and safety of the medical device;
- It has been determined that the risk of harm to health due to the use of a medical device exceeds its effectiveness;
- There is a discrepancy between the data on the effectiveness and safety of the medical device and the information provided in the documents submitted by the applicant;
- Failure to submit the required documentation within 150 days as from the date of state registration of the medical device;
- Failure to provide within 5 working days from the date of receipt of the RC a sample of medical device for testing (study) for type approval of measuring instruments, as well as failure to execute a contract;
- Documents not provided in full and/or information is inaccurate.
How to get Accelerated Registration of a Medical Device in an Efficient and Timely Manner?
If you require assistance in preparing the necessary documentation in accordance with the relevant standards and norms, and wish to obtain a registration certificate for a medical device in a timely manner without elimination of errors and defects in documentation formalization, we recommend engaging the services of our specialists. We are aware of the challenges involved in preparing the necessary information for the registration of medical devices. This is precisely why our company is committed to providing solutions that will streamline the process and enhance your efficiency!
We believe that our company’s greatest strength lies in our highly skilled and dedicated team of professionals, who are equipped to handle a wide range of tasks with expertise and precision. Our team members hold advanced qualifications and are committed to ongoing professional development through refresher courses.
We believe that our collaboration with you will be most beneficial if we can participate in various training events, where we can gain insights and learn from the experiences of our esteemed colleagues in the field.
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