Zertifizierung von Medizinprodukten in Russland und EAWU

The conformity assessment of medical devices and medicines is a mandatory procedure of state supervision. By conducting this procedure the fulfillment of safety and quality requirements shall be assessed. Following the conformity assessment, a certificate in form of a state registration of medical devices and drugs as well as an EAC declaration is issued in order to confirm that the medical and medicinal products are in compliance with the minimum requirements of the technical regulation in Russia and the EAEU. The purpose of the conformity assessment is to guarantee the safety of the products. Furthermore it is not possible to export commodities to Russia and the EAEU without such certificate.

Legal Framework

In the EAEU the requirements for medical devices have been harmonized. The basis for the conformity assessment of industrial plants is provided by the legislation of the EAEU and the Russian Federation and especially by the following regulations and decisions:

Scope of application

According to the Agreement on Common Principles and Rules for Circulation of Medical Products within the EAEU of december 23, 2014, all tools, devices, equipment, material and other products used individually or in combination with each other for medical purposes count as medical devices. The same applies for all supplies, that are necessary for the intended use of these products (including special softwares).

Medical devices are meant for prevention, diagnosis, treatment of diseases, medical rehabilitation of the human body condition, medical research, transformation of anatomical structures or physiological functions of the body or termination of pregnancy. The functional purpose of these products is not only realized by pharmacological, immunological, genetic or metabolic effects on the human body, but is also supported by medication. In vitro diagnostics also count as medical devices.

Conformity assessment procedure for medical devices

The EAC marking usually has to be carried out for such medical devices, that underlie the TR CU 020/2011 “On the electromagnetic compatibility”.

The state registration is valid for all kind of medical devices.

Classification of medical devices according to danger class

According to the decision of the Eurasian Economic Commission Board of december 22, 2015 no. 173 “On Approval of Rules for Classification of Medical Products Depending on the Potential Risk of Their Use”, medical devices are subdivided in 4 danger classes:

  • class 1 – low risk potential: microscope, scale, medical clothing ecc.
  • class 2а – average risk potential: lenses, laboratory equipment, inhalation devices ecc.
  • class 2b – high risk potential: intraocular lenses, condoms, X-ray machines, infusion pumps, defibrillators ecc.
  • class 3 – very high risk potential: hip and knee joint implants, cardiac catheter, breast implants, lithotripter ecc.

Procedure of state registration for medical devices

State registration and inspection are necessary prerequisites for selling products on the market of the EAEU. The registration is conducted by the government authority. In Russia the Federal Authority for health control - Roszdravnadzor - is responsible for it. After the successful completion of the conformity assessment procedure a registration certification is issued. The registration certification is open-ended and valid in every member state of the EAEU.

The state registration is carried out in the following manner:

  • Preparation of the necessary documentation (technical documentation, instruction manual, pictures and drawings as well as other relevant documentations) and if necessary the correction of the submitted documentations according to the legal requirements
  • Application to Roszdravnadzor
  • Testing of the medical devices
  • Issue of registration certification

You can find more informations about the state registration of medical devices here.

EAC declaration process

The EAC-declaration process is the following:

  • Specification of the product
  • Determination of the declaration scheme
  • Selection of samples and testing them
  • Issue of declaration
  • Marking of the product

You can find more information about the EAC declaration here.

EAC Marking

EAC Konformitätszeichen, EAC Zertifikat, EAC Zertifizierung

The EAC-MED Marking indicates the conformity of the product with the safety and quality requirements of the EAEU. If products are sold on the market without appropriate labeling, it may be punished with fines and confiscation. The specifications for EAC-MED Marking are defined by the Decision of the Eurasian Economic Commission Council of february 12, 2016 no. 26 “On Special Trademark of Circulation of Medical Products in the Market of the Eurasian Economic Union".

Authorized representative

Bevollmächtigter VertreterThe manufacturer, which is not established in one of the Member States of the Eurasian Economic Union, is not entitled to apply for any assessment of conformity of medical equipment or medicines with the specified technical regulations.

In order to receive the conformity certificate, the foreign manufacturer must appoint an authorized representative in one of the member states of the Eurasian Economic Union. He represents the interests in the certifying bodies of the Eurasian Economic Union regarding the safety and quality of products and compliance with technical regulations.

In accordance with applicable law and in accordance with the technical regulations of the Eurasian Economic Union, only an entrepreneur residing in the territory of the Customs Union may be designated as an authorized representative.

Time duration and costs of state registration procedure and EAC declaration

The conformity assessment procedure of medical devices is a complex, cost intensive and permanent procedure. Time duration and costs of the registration depend on many factors, such as the type of device, its complexity and the scope of the necessary laboratory tests.
The exact conditions of the state registration are always determined individually on the basis of the documents received.
Please note that the application for state registration can take 6 - 12 months.

Please send us a detailed description of your product and our experts would offer you an appropriate conformity assessment procedure.

Delivery of documents

You will receive a copy of fire safety declaration by e-mail immediately after the procedure has been successfully completed. In just a few days, the original will be delivered to you by post.

Our offer

Our export consultants have many years of experience in the import of medical devices and medicines to Russia and its conformity assessment and customs processing. We offer a comprehensive service package, which includes the preparation of all necessary documents, the corresponding customs handling, and the logistics. We will help you acquire necessary certificates and permits.

We offer:

Please call us or send us an email. We will provide you with a free, non-binding quote and will be glad to answer all your questions about Certification for medical devices and medicines for Russia and EAEU. Convince yourself of the quality of our services!

In our video, we explain what an EAC Certification is and how and where to certify or declare your products for the introduction on the EAEU market.

The EAC Certification and the EAC Declaration are complex procedures that attest your products the conformity with the technical regulations of the EAEU and require a lot of know-how. Schmidt & Schmidt will support you with the certification of your products for the EAEU market.

The EAC certificate of the Eurasian Economic Union (EAEU) is an official document, that proofs the conformity of the products with the harmonized technical regulations of the member states of the EAEU. The products, whose conformity with the technical regulations could be confirmed by the certificate of the EAEU, may be moved and sold in the whole customs area of the member states of the EAEU.

The EAC Declaration of the Eurasian Economic Union (EAEU) is an official document that proofs, that the products meet the minimum requirements of the technical regulations of the EAEU. An EAC declaration is issued by the manufacturer, importer or an authorized representative and listed in the official register. Those products, whose conformity with the technical regulations are confirmed by the declaration, have the permission to be freely moved and sold in the whole customs territory of the member states of the EAEU.

The EAC certificate can only be issued after a quality assessment, which has to be carried out by a certification body accredited in one of the member states of the Eurasian Economic Union. The certification is conducted on the basis of technical documentations, company-internal created test reports, or rather test reports provided by accredited test laboratories, as well as on basis of a manufacturing audit on site. The certificate is printed on an official pre-printed form, which has several forgery-proof elements and is authenticated by the signature and seal of an accredited body. The EAC certificate is usually issued for “complex” products that require an extensive control by the authorities.

With the EAC Declaration the manufacturer, importer or authorized representative declares the conformity of his products with the minimum requirements of the technical regulation of the Eurasian Economic Union (EAEU). As distinguished from the EAC certificate, the EAC declaration is issued by the manufacturer or importer himself. All necessary tests and analysis are or made by the manufacturer or in some cases by the laboratory. The applicant issues the EAC declaration himself on a usual piece of paper. The EAC declaration has to be listed in the uniform register of the EAEU by an accredited certification body of one of the member states of the EAEU.

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