REGISTRATION OF MEDICAL DEVICES ACCORDING TO THE EAEU RULES
What is the EAEU?
The Eurasian Economic Union (EAEU) is an international organization for regional economic integration with international legal personality and established by the Treaty on the Eurasian Economic Union. The EAEU ensures the mobility of goods and services.
Which countries are members of the EAEU?
- The Russian Federation
- The Republic of Armenia
- The Republic of Belarus
- The Republic of Kazakhstan
- The Republic of Kyrgyzstan
Submit your registration dossier in Russia. Choose one or more of these countries. If, for example, Roszdravnadzor makes a favourable decision, you will receive one general registration certificate. With this document, you can ship the products to the countries of your choice.
Do you have a question: “Why else are new rules needed?”
We will give nothing else than this information:
From January 1, 2022, this registration option will be the only one.
In other words, after the New Year holidays, it will no longer be possible to submit a registration dossier according to the national rules of Russia.
From January 1, 2022, the exemption from value added tax, provided for by the specified subparagraph of paragraph 2 of Article 149 of the Code, applies if a registration certificate of a medical device issued in accordance with the law of the Eurasian Economic Union has been submitted to the tax authority.
The scheme for registering medical devices according to the rules of the EAEU will be as follows.
The deadlines are written from the date of filing the registration dossier. Add to this the time for the preparation of documents, their development, testing and you get at least 1.5-2 years.
Registration according to the EAEU rules has its own characteristics and differences from the national registration procedure.
Let’s take a look at some of them:
- a registration certificate issued in accordance with the rules of the EAEU will be valid, at your choice, in two or more countries where it is recognized as valid. It is possible that the certificate will be allowed to register only for one country. We are waiting for a decision in relation to this matter. Follow our news on our website and Vkontakte
- during the registration process for sterile products of risk classes 2a, products of risk classes 2b and 3, inspectors will come to check the production. If there are several production sites, then each of them will be checked. This generates additional inspection costs. The costs are significant. This is currently not provided for by national registration rules.
- if the product is risk class 2b or 3, the likelihood is great that clinical trials will be conducted with patients. Insurance, enrolment of patients, informed consent… Additional costs, increase in terms of preparation of the registration dossier.
- additional state fee for the approval of the examination.
- in other countries that have recognized the EAEU rules, the expert opinion will be checked again. As many countries you choose, there will be as many additional checks. If one of the countries that have recognized the EAEU rules does not confirm the favourable conclusions of the expert investigation, then the registration certificate will not be valid in that country.
- it will be possible to submit the registration dossier to Roszdravnadzor, as before. It will be possible to apply for registration and/or conduct tests in any other country of the Union. However, in order for the registration certificate to be valid in Russia, Roszdravnadzor will still check the documents.
- registration under the rules of the EAEU will take longer and will be more difficult. Here are the statistics from the official website of the Union: The average pendency time before the issuance of a registration certificate is 363 days. The average pendency time before rejection is 205 days.
- the new rules for the registration of medical devices in accordance with the EAEU rules have been in effect for 3 years. During this time, 4 registration certificates were issued. Of these, 2 were based on applications that were filed in Russia. Registration denied — 20. Under consideration — 14. Total — 36.
You always have a choice:
- study the EAEU resolutions and reference documentation and try to go through all the stages on your own
- contact another consulting company
- clarify the conditions and contact our company for help in registration
We sincerely wish you to make the right choice.
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- toll-free number 8 800 201- 27- 87
- +7 812 331-09-44 (office on Rustaveli Street in St. Petersburg)
- +7 495 679-84-25 (office on Myasnitskaya street in Moscow)
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