Electrontest LLP ensures that the technical and operational documentation submitted by the Applicants is amended in accordance with the requirements of the National Regulatory Authorities of the EAEU Member States and the decisions of the ECE on the authorization of medical devices, as well as the organization of the testing panel (technical, toxicological and clinical) in national testing facilities and associated accredited laboratories.

Electrontest LLP focuses on an integrated approach to the authorization of medical devices (MD) in the Republic of Kazakhstan, and in other national systems of the EAEU member states. We draw on years of experience of our employees in the field of authorization of medical devices, as well as on the infrastructure of the Electrontest group of companies (Russian Federation), which includes testing facilities for medical devices accredited to conduct technical and toxicological tests of MD.

We facilitate preparation of both technical documentation (technical specifications for domestic producers) and maintenance documentation for medical devices in accordance with the regulatory documents of the Republic of Kazakhstan and other EAEU member states.

Electrontest testing facilities

Electrontest LLP organizes testing of medical devices in the testing laboratories of the National Center for Expertise of Medicines and Medical Devices of the Republic of Kazakhstan, as well as in the testing facility of Electrontest LLC in the Russian Federation. The testing facility of Electrontest LLC includes two testing laboratories:

Testing laboratory TL TEFR Electrontest LLC

Testing laboratory ElectrontestBio LLC

Accredited by RusAccreditation for technical testing of MD (link to the accreditation certificate) in accordance with the requirements of GOST ISO 17025 and having an international ILAC compliance certificate with the requirements of ISO 17025 (link to the ILAC certificate) TL TEFR Electrontest LLC is also accredited in the EAEU to conduct technical tests of all types of medical devices, including In Vitro products, for the purpose of authorization in the EAEU.

The principal activity is testing of medical devices and medicinal products regarding their biological safety. TL ElectrontestBio LLC is accredited by RusAccreditation. Accreditation certificate RA.RU.21OM13 for testing medical devices and medicinal products to assess their biological safety. Has a license of Rospotrebnadzor 77.01.13.001.Л.000083.11.21 for handling microorganisms of III and IV risk groups.

Electrontest LLP also includes a clinicodiagnostic laboratory accredited to conduct technical, clinical trials of in vitro medical devices, as well as clinical and laboratory tests of medical devices for the purpose of registering in vitro products in the EAEU.

Ensuring the completeness of Registration dossiers
drawn up in full compliance with the requirements of all regulatory authorities. In particular, the dossier drawn up can be submitted in any state of the EAEU for the purposes of national authorisation or out-licensing medical devices in the EAEU, regardless of the choice of the Reference State and the Member States concerned.

Relying on the technological capabilities of the engineering companies of the Electrontest group, the task is to develop national testing facilities of the EAEU member states, their integration into the common scientific and technical space for testing medical devices, alignment of the technical and organizational capabilities of testing laboratories in order to improve the compliance verification of all commercial medical devices in the EAEU.

Working with us, you will save precious time and money, as we will take upon the preparation of all necessary documentation in accordance with the requirements of regulations and regulatory authorities, as well as support of the authorization process after submission of documents to the notified body

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.

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