Registration of medical devices • Медрелис
Registration of medical devices

Registration of medical devices

Registration of medical devices is a prerequisite for their importation to, use, sale, and manufacturing in the Russian Federation. State registration is mandatory for all medical instruments, apparatus, devices, equipment, materials and other medical products.
How we arrange for registration of medical devices
We define an overall goal
It is very important to define how your medical device will be registered, how you intend to import and distribute it, how you are going to deliver it to medical facilities, and whether you are going to take part in tenders. We will help you solve these and many other issues in order to define a clear way we will follow together
We prepare an application for registration
We identify the product composition, accessories, the number of design modifications, and classification codes. A properly completed application largely determines the future success in the registration process
We complete the documents for importation of the medical device to the Russian Federation
For foreign-made medical devices, we prepare all documents necessary to obtain an import permit from the Federal Service for Surveillance in Healthcare (Roszdravnadzor)
We collect a package of documents
Each registration case is unique in its own way. We will help you to correctly set links between the developer, manufacturer and production sites. We provide documentary evidence of the quality, performance and safety of medical devices. An appropriate set of document is a reliable evidence for any registration
We prepare technical, operational and regulatory documentation
We know what Roszdravnadzor pays attention to. Therefore we develop or adapt the documentation for medical devices to make sure it is accepted without objections
We support your case with Roszdravnadzor
Disputes that sometimes may arise during the registration of medical devices require a competent response, such as to resolve objections or appeal against wrongful expert decisions. We can solve these issues in a professional manner

FAQ

How long does it take to obtain registration for a medical device?
Risk Class I: 6 to 8 months
Risk Class II and III: 9 to 12 months

The timing of registration may vary depending on many factors, such as the complexity of the medical device, completeness and quality of information about the medical device, how prompt the manufacturer is in providing any missing data for the medical device, etc.

The duration of the registration process may be shortened. Please contact us for a detailed review of the documentation for your medical device.
What is the procedure for paying the registration fee for medical devices?
The cost of registration is fixed and depends on the risk class and the number of modifications of your medical device. We divide the fee into 12 equal parts payable on a monthly basis.

We arrange for your direct contracts with all the parties involved (laboratories, testing centres), so that all payments are transparent.
Are your partner laboratories reliable?
We work only with proven laboratories, whose reports are accepted by Roszdravnadzor. Our extensive and successful experience of cooperation with them has given us a sustainable understanding of who is best to engage for technical, toxicological and clinical trials of medical devices based on their specific features.

Our specialists always thoroughly check the test reports before they are approved, so the probability of errors is minimal.
What is required for the registration process?
  1. Provide us with necessary documents to prepare a master file for your medical device
  2. Inform us of your preferences as to importing and distributing your medical device, whether you are going to take part in tenders, etc.
  3. Promptly provide any missing information about your medical device during the registration process
  4. Sign all documents required for the registration of medical devices, such as contracts, powers of attorney, and letters.
You will know from this video:
1. Current (2021) situation with registration of medical devices in Russia and other EAEU countries (Belarus, Kazakhstan, Kyrgyzstan, Armenia).
2. How long will be national Russian, Belarusian, Kazakh and Kyrgyz registration certificates for medical devices vaild?
3. What are the difference between Russian and EAEU medical devices registration procedures: clinical trials with human, manufacturing inspection.
4. How much countries the EAEU registration certificate for medical device will be valid for?
5. How much authorized representatives in the EAEU must manufacturer have?
6. Is Eurasian registration of medical devices (medical products) longer than Russian and why?
7. Who can help manufacturer of medical devices with the registration and circulation of medical devices in the EAEU?
What are the new Eurasian Union regulations in the circulation and registration of medical devices? Are they really so hard?

We are trusted

How to contact us?
Do not be shy |
We appreciate the communication with our customers.
+7 (495) 785-72-85
+7 (495) 785-72-84
info@medrelic.ru
Moscow, 109074
2/5/4 Slavyanskaya square, build. 3, office 4057

We are at the metro station Kitai-gorod, in a nearby building with Roszdravnadzor
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