Since 2017, it has become possible to obtain a registration certificate according to the rules of the Eurasian Economic Union (EAEU). The medical device registration is described in the Resolution No. 46 of the Eurasian Economic Commission Council dd. February 12, 2016, and the requirements for technical and clinical tests — in the Resolutions No. 28 and No. 29 of the EEC Council dd. February 12, 2016. This procedure allows you to register a medical device and obtain a single registration certificate. After your medical device is registered according to the EAEU rules, you will be provided with a document in the form of a registration certificate, which allows you to enter the markets of several member-countries of the EAEU (Armenia, Belarus, Kazakhstan, Kyrgyzstan, Russia) at the same time.
A reference state is a country where the dossier is filed. The EAEU-related registration requires, at least, one country of recognition in addition to a reference state. However, this type of registration has its own peculiarities: a different preparation of dossier and documentation, a different form of researches, etc. To date, the algorithm of medical device registration within the EAEU has not been yet established, so experts have to be able to adapt to the established requirements and monitor even the slightest changes in the legislation.
For the efficient registration, you should better contact an FCRC consultant with extensive experience in these matters. FCRC offers a comprehensive service of medical device registration according to the EAEU rules, which includes full turnkey project support. So, we are ready to proceed with and successfully pass all stages of medical device registration.
Main stages
The work is organized under a specific layout developed with account of a number of nuances. What we will do for you:
- Determine the code and risk class of devices, draft an application for registration in a reference state and a state of adoption.
- Promptly develop the documentation necessary for testing.
- Select accredited testing centers and advise you on the timing and cost of services.
- Supervise the testings. Provide a laboratory with all necessary samples. Check test records and, if necessary, agree with you on and include any adjustment in the documentation.
- Collect the registration dossier according to the EAEU rules. Agree on the final dossier with a MAR or manufacturer.
- File the final dossier to Roszdravnadzor to check the completeness and accuracy of the registration dossier.
- Promptly respond to requests from Roszdravnadzor, and address comments, if any.
- Support during inspection control of production. *
- Receive a decision for the examination of medical device quality and safety, and address comments, if any.
- Inform you on the need to submit copies of payment for state examination and registration services in recognition states. Receive such payment copies from you.
- Translate necessary documentation into the languages of recognition states for submission to the competent bodies.
- Provide documents with translations to Roszdravnadzor for expert review by recognition states.
- Inform you about the registration completion. If such completion is successful, a registered device will be entered into the register of medical devices, and you will receive the original registration certificate.
You are required:
- To provide legal documents on the company and the most complete information about the device
- To pay in a timely manner (state duties, tests, translations, etc.)
- To answer our questions.
The mandatory production inspection for medical devices of risk classes 2a sterile, 2b, 3 is performed by an authorized body or specialized entity. The production is inspected prior to the preparation of the expert opinion, i.e., as part of the state examination of the registration dossier.
If necessary, we can provide services for preparation for inspection control, development of a product quality management system in accordance with GOST ISO 13485-2017.
Here are the parameters that distinguish the two types of medical device registrations—according to the national rules and in accordance with the EAEU rules
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Distinctive features |
National rules of the Russian Federation |
EAEU rules |
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Scope of RC |
Only in Russia |
In the EAEU countries that approved the expert opinion on the MD, issued by a reference state (up to 5 recognition countries and, at least, 1) |
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Cost of registration |
State duties established in Russia are paid |
State duties of all countries specified in the state registration application are paid (reference state + up to 5 recognition countries and, at least, 1) |
|
Registration dossier |
- fewer documents |
- extended package of documents |
|
Cases of human clinical trials |
- medical devices that have no analogues in Russia |
- medical devices that have no analogues |
|
Cases of technical trials of IVD medical devices |
Tests apply to all devices (except for state registration of Russian MDs under GR 552) |
Tests apply to all devices, except for reagents, reagent kits, controls, calibrators, washing solutions and culture media |
|
Frequency of production inspection control once RC is issued |
Every 5 years |
Every 3 years |
|
Main stages of registration |
|
|
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Approximate term of state registration subject to risk classes |
||
|
Class 1 |
6-9 months |
10-12 months |
|
Class 2а (non-sterile) |
8-12 months |
12-20 months |
|
Class 2а (sterile, non-implantable) |
8-12 months |
15-24 months |
|
Classes 2а (sterile implantable), 2b, 3 |
10-15 months |
31-39 months |
Documents required for medical device registration
The medical device registration requires an applicant to file the following package of documentation to Roszdravnadzor:
- Application for medical device state registration in a special form
- Manufacturer’s notarized power of attorney (if necessary)
- Copies confirming the payment for examination and state registration services
- Registration dossier.
Then, the dossier must include the following documents: copy of RC, information about a manufacturer, declaration of conformity to quality requirements, test records, reports of recalls and accidents, medical device certificate with description of its intended use, scope, labeling data, etc.
Our experts will advise you on the accurate list of documents. In the event of any missing device technical document, we are going to assist you in drafting them or write them completely for you. Our work will result in the issuance of a registration certificate.
FCRC registers any types of medical devices:
- Medical equipment
- Medical products
- Consumables
- Devices for in vitro diagnostics
- Medical instruments
- Medical furniture
- Dedicated software.
Why it is worth to contact us
Our clients choose us for the following reasons:
- Team of highly qualified and deeply experienced specialists
- We draft a registration certificate from scratch or proceed with any stage of work
- We set and assure our strict commitment to realistic deadlines
- We refund the cost of services, in case of failed registration due to the company’s fault.
- Transparent pricing policy
- High (97.8%) result of positive registrations.
To calculate the cost of state registration of your device and receive a price quote, please, apply by e-mail info@fcrc.consulting or by phone +7 (495) 374-00-19. For accurate calculation of the timing and cost of work, send us a description and all available documentation.