If you need to find information about a medical device on the website of Roszdravnadzor, including information about the registration certificate, instructions for use and photographic images, it is recommended to visit the official website of Roszdravnadzor, where the Register of Russian Medical Devices is located.
If you have any questions related to finding a registration certificate for a medical device or any other information about it, the qualified specialists of UCEC «QUALITY» LLC are ready to provide all the necessary recommendations. We also provide professional services in the field of preparation of documents for authorisation of technical, toxicological and clinical tests. Due to careful study of all legislative documents and regular monitoring of changes in them, as well as solid experience in the field of registration procedure, you can count on granting a registration certificate for a medical product in a short period of time, without additional financial and time costs.
Table of Contents:
- What is the state register of Russian medical devices?
- How can I find information about a medical device on the Roszdravnadzor website?
- Search for medical device registration certificate in the registry
- What information does the registration certificate contain?
- We provide qualified assistance in obtaining regestration certificate for medical devices in Russia
What is the state register of Russian medical devices?
The state register of medical devices and organisations engaged in the manufacture of health products provides detailed information about all the above-mentioned products that have undergone the registration procedure according to the national Rules of Russian Federation.
Despite the availability of other electronic resources that allow you to find information about a medical device, only the official website of Roszdravnadzor, where the state register of medical devices is located, displays reliable data. This is due to the fact that the federal body for supervision in the field of health protection carries out constant activities to update the Register.
The electronic service Register of Medical Devices is located at: https://roszdravnadzor.gov.ru/services/misearch
How can I find information about a medical device on the Roszdravnadzor website?
As of 01.03.2022, within the framework of the Resolution of the Government of the Russian Federation No. 1416 of 27 December 2012 “On Approval of the Rules for State Registration of Medical Devices”, the federal body for supervision in the field of health protection has provided additional information on health products that have previously undergone the registration procedure. It is about photos and instructions on the use of medical devices.
To find a licence or registration certificate on the Roszdravnadzor website relating to a particular health product, it is recommended to follow the following algorithm of actions:
1. It is necessary to go to the website of Roszdravnadzor https://roszdravnadzor.gov.ru and select the “Services” (Сервисы) section.
2. Further it is necessary to go to the State Register of Medical Devices and Organisations carrying out production activities in relation to health products.
3. In the search box, enter the name or medical registration certificate number of the product developed for use in wellness.
4. If for some reason you cannot find the full name or registration certificate number of a medical product, you can use the advanced search, which allows you to enter additional data about the product.
5. After specifying all the required information, the system will display the requested information.
6. Next, go to the page of the above medical device. This will allow you to find an entry in the registry with links to download the RI, instructions and photographic images. To obtain the required information, follow the appropriate link.
Search for medical device registration certificate in the registry
Initially it is necessary to consider the main features of the registry. Visitors can use 2 ways: simple and advanced search.
The first search option allows you to find a medical regestration certificate on the Roszdravnadzor website only by its number or product name.
If the user does not know the full name of a medical device, it is possible to enter only a part of it into the search box. In such situations, the system displays expanded results according to the keywords. In addition, the search results can be saved in Excel format.
The second search option (advanced search) provides more options for users to enter queries. These include:
- Registration certificate number;
- Date of the registration procedure;
- Period during which the registration certificate is considered valid;
- Information about the organisation involved in the manufacture of medical device (name, legal address, location, etc.);
- Potential risk category (1, 2a, 2b, 3);
- OKPD code 2;
- Intended purpose of the product of health-improvement specificity;
- Location of the manufacturing organisation;
- Code of medical device type according to the nomenclature classification;
- Information on interchangeable products;
- Register entry number.
The results of the advanced search can also be saved in Excel format.
What information does the registration certificate contain?
The document provides the following information:
- TIN;
- Date of receipt and expiry date;
- Name of the manufacturing company;
- Name of the equipment;
- Reference to technical specifications or regulations that show the requirements for the equipment;
- Potential risk category to which the MI belongs;
- Conclusion on the possibility of application;
- Signature of the director and stamp of the federal body for supervision in the field of health protection.
The certificate is a guarantee that the equipment has passed the tests specified in the regulations and has already been entered in the Mdeical Devices Register and can be used as intended without risk of harm to the patient’s body.
We provide qualified assistance in obtaining regestration certificate for medical devices in Russia
If you do not have the opportunity and time necessary to thoroughly study the legislation, and if you do not want to go through the registration procedure several times due to improperly executed documents, entrust your concerns to professional specialists. In addition, this will avoid the need to pay the state duty multiple times, which occurs each time you try to submit a new application.
Experienced specialists of our certification centre are able to provide competent assistance in obtaining a registration certificate. We are also ready to provide detailed advice on how to find a registration certificate for medical devices on the Roszdravnadzor website.