Analysis of medical products, determination of risk class. Formation of the Registration Dossier

1

Proof of safety and efficiency: technical testing; tests (studies) to assess the biological effect of a medical product; tests for the purpose of type approval of measuring instruments in relation to medical products classified as measuring instruments; clinical trials (studies)

2

Submission of the package of collected documents to the authorized registering body:
• application for expertise and registration of a medical product;
• registration dossier;
• copies of documents confirming payment for expertise and registration of a medical product in the reference state

3

Quality, efficiency and safety examination of medical products

4

Inspection means an examination of production for compliance with technical requirements in accordance with the Requirements for the Implementation, Maintenance and Evaluation of the Quality Management System for Medical Products depending on the potential risk of use thereof.
Production inspection is mandatorily scheduled for sterile products of risk class 2a, 2b and 3. For class 1 and non-sterile risk class 2a products, inspection may be conducted on a voluntary basis

5

Alignment of the expert opinion by the states of recognition

6

Obtaining a Registration Certificate of the established form

7

Registration of medical products with the EAEU countries

Registration of medical products in the Eurasian Economic Union (EAEU) can be carried out at the applicant's choice either in one or several member states of the Union (the state of application is the reference state, the others are the states of recognition). This means that manufacturers and importers are given the flexibility to choose in which EAEU member state they wish to register their medical product.
In case of a positive examination in the reference state, the dossier shall be examined in the other states of recognition indicated by the applicant. This process, known as mutual recognition, assists in simplifying the process for manufacturers and importers and ensures that medical products are available to patients throughout the EAEU. At the moment, the EAEU includes the following member states: Republic of Armenia, Republic of Belarus, Republic of Kazakhstan, Republic of Kyrgyzstan, Russian Federation.

The registration process takes between 6 and 15 months. The terms depend on the risk class of the product, the number of design options and other characteristics.

If we compare registration within the EAEU with the national system, then it implies a more complex and thorough check by an expert organization. The review period has also been extended.

Attention should be paid to the fact that it is not possible to register the product only in the reference state. At least one state of recognition is required to be selected for registration.

The applicant for registration can be a manufacturer who is a resident of an EAEU member state or its authorized representative, who must also be an EAEU resident. Electrontest LLP is ready to become your authorized representative in Kazakhstan.

Stages of registration of medical products in the EAEU

After preparing the application for registration and the documents provided for by the current legislation, they are submitted to the registration authority. Our activity does not stop at this stage. Our specialist will provide full support for the state registration procedure at all stages in the registration authority, as well as eliminate all questions that may arise at each stage of the state registration procedure.

You can find the entire regulatory framework governing the rules of registration in the EAEU member states in the "Regulatory Documentation" section.

Our company "Electrontest" is willing to help you register your medical product in accordance with the EAEU regulations. Our team is well aware of the EAEU standards and will guide you through the registration process at all stages, ensuring that your product meets all the necessary requirements. Upon successful completion of this procedure, you will be able to circulate your medical product throughout the territory of the EAEU.

It is worth remembering that all types of tests must be conducted at institutions and organizations selected by the applicant and included in the Unified Register of Authorized Organizations entitled to conduct research (testing) of medical products for the purposes of registration thereof. The Electrontest Group disposes of its own testing facilities, which allow to assess the safety and efficiency of registered medical products in full and in the shortest possible time. Our laboratories have the necessary accreditations, which allows us to conduct research in line with the requirements of the EAEU.

A medical product that has undergone the registration procedure established within the EAEU is labeled with a special mark for the circulation of medical products on the market of the Eurasian Economic Union.

Registration certificates received as part of the registration procedure under the rules of the EAEU are valid indefinitely.

Registration of medical products under the EAEU rules is a more complicated procedure compared to the national process due to the strict standards established by the Rules for Registration and Expert Review of Safety, Quality and Efficiency of Medical Products (Decision of the EEC Council No. 46 of 12.02.2016). As part of the registration of medical products under the EAEU rules, the manufacturer is subject to stricter requirements for medical products and registration dossier documents. These standards are intended to ensure the safety and efficiency of medical products for patients in all EAEU member states.

Astana, st. Anet baba, 9/3

+7 (776) 326 2500
+7 (702) 999 1964
+7 (701) 419 2225

Our work is based on a deep knowledge of regulatory documents, an understanding of the physics of processes in medical devices, the high qualification of our experts and, most importantly, on our own test base.

Company group

Our services

Contacts

_{For request:}
electrontest.kz@gmail.com