REGISTRATION OF MEDICAL DEVICES UNDER THE EAEU REGULATIONS
For the purposes of registration under the EAEU regulations, the requirements for medical devices and documents in the registration dossier are more stringent than in case of registration under the national (Russian) regulations. Holding a Registration Certificate under the EAEU regulations is a strong competitive advantage on the medical device market. Our team is willing to provide you with professional assistance in the development, adjustment and preparation of all the necessary documents for your registration dossier, as well as support in the registration process with the Authorized Bodies.
Medical devices intended for the Eurasian Economic Union market are registered in the manner defined by the Rules for Registration and Examination of Safety, Quality and Efficacy of Medical Devices (Decision of the EEC Council No. 46 dated February 12, 2016).
A medical device may be registered, at the option of the Applicant, in one or more Member States. Presently, the EAEU comprises the following Member States: the Russian Federation, the Republic of Armenia, the Republic of Belarus, the Republic of Kazakhstan, and the Kyrgyz Republic.
IMPORTANT! You cannot get your medical device registered in the Reference Member State only. For registration purposes, you should also choose at least one Member State of recognition.
An application for registration may be filed by a manufacturer resident of a Member State or its authorized representative who shall be also a resident of a Member State.
IMPORTANT! For registration in several Member States, a single authorized representative is appointed for all the countries.
STEP I. PREPARE A LIST OF DOCUMENTS for registration of medical devices
Define a list of documents required for registration purposes
A list of necessary documents for a registration dossier depends on the class of potential risk of use of the medical device.
Based on the degree of potential risk of use, medical devices are divided into four classes in accordance with the Rules for Classification of Medical Devices Based on Potential Risk of Use (Decision of the EEC Board No. 173 dated December 22, 2015).
Prove safety and efficacy
To confirm the conformity to the general requirements for safety and efficacy of medical devices and the requirements for labeling and operational documents (Decision of the EEC Board No 27 dated June 12, 2016) as part of the preparation of documents for the registration dossier, the Applicant shall conduct the following tests:
- Technical tests in accordance with the Rules for Technical Testing of Medical Devices (Decision of the EEC Board No. 28 dated February 12, 2016);
IMPORTANT! For in vitro diagnostic medical devices (reagents, reagent kits, control materials, calibrators), no technical tests are required.
- Biological testing (evaluation) of medical devices in accordance with the Rules for Biological Testing (Evaluation) of Medical Devices (Decision of the EEC Board No. 38 dated May 16, 2016);
- Tests for measuring instrument pattern approval (for medical devices classified as measuring instruments) in accordance with the List of Medical Device Types to be Classified as Measuring Instruments for Registration Purposes (Decision of the EEC Board No. 42 dated February 12, 2016);
- Clinical trials (studies) in accordance with the Rules for Clinical Trials (Studies) of Medical Devices (Decision of the EEC Board No. 29 dated February 12, 2016).
IMPORTANT! The above tests shall be conducted by institutions and organizations selected by the Applicant that are included in the single register of authorized organizations that have the right to conduct testing of medical devices for registration purposes.
STEP II. REGISTRATION AND ASSESSMENT OF THE MEDICAL DEVICE
The Applicant shall submit the following to the Authorized Body in the Reference Member State:
- Application for assessment and registration of the medical device;
- Registration dossier;
- Copies of documents confirming the payment for the assessment and registration of the medical device in the Reference Member State.
IMPORTANT! Fees for the assessment and registration of the medical device in the Member States concerned are paid after a positive decision is made to register the medical device by the Reference Member State. The amount and manner of payment of fees are determined in accordance with the legislation of Member States.
The requirement for manufacturing inspection distinguishes the registration procedure of medical devices under the EAEU regulations from that under the national law. The Authorized Body (Expert Organization) or an organization determined by the Authorized Body (Expert Organization) of the Reference Member State conducts a manufacturing inspection of medical devices in accordance with the Requirements for the Implementation, Maintenance and Evaluation of the Quality Management System for Medical Devices Based on the Potential Risk of Their Use (Decision of the EEC Board No. 106 dated November 10, 2017).
IMPORTANT! For sterile products of Classes 2a, 2b and 3, manufacturing inspection is compulsory. For Class 1 products and Class 2a non-sterile products, manufacturing inspection is voluntary.
If a manufacturer of medical devices of potential risk Class 1 and non-sterile medical devices of potential risk Class 2a has successfully completed an assessment of the Quality Management System for a medical device, covering the design and development processes, then, as long as the opinion contained in the report on the results of the manufacturing inspection remains valid, amendments to the registration dossier of such medical device can be made without an assessment of safety, quality and efficacy through a notice to that effect.
A medical device that has undergone the registration process applicable in the Union is marked with a special symbol for medical devices that circulate in the market of the Eurasian Economic Union in accordance with Decision of the EEC Council No. 26 dated February 12, 2016.
Registration Certificates received as part of the registration process in accordance with the EAEU regulations are valid for an indefinite period of time.
The registration process takes from 6 to 15 months.
Special considerations on the transition from the national registration rules to the EAEU registration rules
In pursuance of the Decision of the EEC Council No. 46 dated February 12, 2019 and Order of the EEC Board No. 28 dated March 9, 2021 “On Draft Order of the Council of the Eurasian Economic Commission “On Draft Protocol to Amend the Agreement on Common Principles and Rules of Circulation of Medical Devices (Medical Products and Medical Equipment) Within the Eurasian Economic Union dated December 23, 2014”, until December 31, 2021, an application for assessment or registration of a medical device can be submitted in the manner prescribed by the laws of a Member State. If an application for assessment or registration of a medical device is submitted in the manner prescribed by the laws of a Member State before December 31, 2021, the registration of the medical device may be completed in the manner prescribed by the laws of the Member State.
Registration documents for a medical device registered in the manner prescribed by the laws of a Member State may be amended, provided a relevant application is submitted before December 31, 2026.