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, Kazakhstan 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, Kazakhstan 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:
- Agreement on Common Principles and Rules for Circulation of Medical Products (Medical Devices and Medical Equipment) within the Eurasian Economic Union of december 23, 2014
- Decision no. 46 of the Council of the Eurasian Economic Commission of february 12, 2016 “On the Rules of registration and professional examination of the safety, quality efficacy of medical products”
- The treaty on the Eurasian Economic Union of may 29, 2014
- Decision no. 173 of the Eurasian Economic Commission Board of december 22, 2015 “On Approval of Rules for Classification of Medical Products Depending on the Potential Risk of Their Use”
- Decision of february 12, 2016 no. 27 “On Approval of General Requirements for safety and efficacy of medical products, requirements for their marking and operational documentation on them”
- 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”
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
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
The 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.
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.
