It is a legal requirement for medical devices to be registered in order to facilitate the unimpeded circulation of medical devices within the Russian Federation. Please be aware that the sale of unregistered goods may result in administrative and criminal liability. It is therefore essential to treat this matter with the utmost seriousness and care.
The general procedure for registration has been previously discussed. There may be instances where specific considerations are required when registering a series (batch) of medical devices due to the presence of special features or nuances. Let us proceed with a discussion on this matter.
Obtaining a registration certificate from Roszdravnadzor is a time-consuming and labor-intensive process. The process begins with the collection of the necessary documentation. It is the responsibility of the manufacturer (producer or developer of medical devices) to collect and submit the following documentation in paper format to the relevant state expert institutions:
- An application for the state registration procedure for devices executed in accordance with the approved requirements;
- A copy of documents that confirm the authority of the manufacturer’s representative (if any);
- A package of documents that confirm the applicant’s legal rights to a batch (series) of medical devices;
- Technical file for the device (if available);
- Operating documentation for a medical device;
- Clear images of the medical devices in question, with dimensions of 18 by 24 cm. In this instance, the photograph should also indicate, where applicable, the devices that will be used in conjunction with the item in question;
- Written confirmation of the results of all studies and tests including toxicological studies, if the device is to be used in direct contact with the patient's body. Furthermore, the results of clinical trials must be provided, carried out in strict accordance with the standard research program. Please refer to the official sources of expert institutions for further information on this program.
It should be noted that in the event that studies have been conducted that do not comply with the standard program, the expert committee will determine whether they have been conducted to a sufficient extent to obtain permission to register a batch of medical devices.
Another important factor is the collection of other documents confirming the safety, reliability and effectiveness of medical devices.
If the package of documents is not provided in Russian, the applicant shall attach a certified translation.
The application for registration authorization shall include the date and outgoing number. Individual entrepreneurs and legal entities shall also attach a seal imprint. The application shall be completed in accordance with the established rules set out in Appendix No. 1 to the Order of the Federal Service for Surveillance in Healthcare dated 06.05.2019.
The submitted package of documents will be reviewed within three working days. If the inspection is successful, Roszdravnadzor will execute a registration certificate in line with the established standards and send it to the applicant via one of the following methods: registered mail, courier by power of attorney, or telecommunication channels. In this case, the series of medical devices shall be entered into a special register.
Simplified Procedure for Registering a Batch or Series of Medical Devices
In April 2020, a Government Decree was approved which set out the specifics of the circulation of medical devices including the registration of a batch of medical devices at the state level.
In accordance with this Decree, we have established an accelerated procedure for registering a batch of devices that are used in special conditions including military operations, emergency situations, the fight against diseases that pose a threat to others, and diseases that have appeared due to the negative impact of various factors (radiation, chemical and biological).
What Devices are Included in this List?
- Artificial lung ventilation devices;
- Isolation and surgical suits;
- Sample collection and transportation kits;
- Oxygenators;
- Respiratory apparatuses and masks;
- Protective overalls, shoe covers, gloves;
- Artificial blood circulation systems;
- Body temperature recorders;
- Medical clothing kits and much more.
You can find a complete list of all devices in the appendix to the above-mentioned resolution.
The registration of medical devices included in the above list is carried out in accordance with a streamlined procedure, with the shortest possible time frame. To initiate this process, please submit a duly completed application and documentation package to the relevant authorities, along with the state fee payment.
If you require a Roszdravnadzor registration certificate in the shortest possible time, it is advisable to engage the services of professionals who specialize in this area.
To ensure that we always have the most up-to-date information, our employees regularly participate in various forums and conferences, share experiences and learn from colleagues. As a result, when you contact us, you can be confident that the services provided will be of the highest quality. Our specialists will complete all the work within the agreed time frame, which will entitle you to a registration certificate from Roszdravnadzor and the opportunity for problem-free circulation of medical devices in Russia as quickly as possible.
It is quite easy to contact the company’s consultants! To arrange this, please contact us via the telephone numbers provided on our website. Alternatively, you can request a callback. Our specialists are available to provide consultation and guidance on any issue, assisting you in making the most appropriate decision!