Kardioelectronica and Medical Equipment Testing Institute will create a unified system of standards for implants
The leading Russian manufacturer of cardiac pacemakers – Kardioelektronica of the Rostec State Corporation and the Federal State Budgetary Institution "VNIIIMT" of Roszdravnadzor – have signed a cooperation agreement. The parties plan to jointly develop projects in standardizing implantable medical devices. The agreement was signed during NOVAMED-2025 forum.
The document was signed by the General Director of Kardioelectronica, Sergey Dmitrochenko, and the General Director of the Federal State Budgetary Institution "VNIIIMT" of Roszdravnadzor, Igor Ivanov.
As part of the agreement, two sides will create and introduce standards for key implantable devices, such as pacemakers. The goal is to make them interchangeable and ensure their efficient use in Russian hospitals. This collaboration will be carried out under the import substitution program.
«The establishment of a domestic standardization framework for implantable medical devices is fundamental to achieving technological sovereignty. Unified standards are essential for guaranteeing the efficiency, safety, and quality of patient care. This is particularly crucial for cardiac pacemakers, with over 50,000 implantation procedures performed annually in Russia. Our agreement with VNIIIMT will leverage combined scientific and industrial expertise to develop a modern, internationally aligned standards foundation», — says Sergey Dmitrochenko, General Director of Kardioelectronica.
Kardioelectronica, an enterprise of the Rostec State Corporation, is a leading domestic manufacturer of cardiac pacemakers. Leveraging deep practical expertise, extensive experience, continuous modernization, and rigorous production standards, the company has achieved a consistently high level of quality of products. Today, Kardioelectronica stands as the only Russian producer of MRI-compatible pacemakers and leads. Among its latest developments is the Apollo MRI cardiac rhythm support device, which intergrates the company's accumulated experience and cutting-edge technical solutions.
«Our partnership with industry leaders like Kardioelektronica is a key mechanism to transform scientific research into practice and accelerate the unification of the standards. The practical expertise from their specialists will enable us to move our research forward and test protocols more precisely to meet real-world manufacturing needs. This partnership marks a significant step toward enhancing the quality and safety of Russian‑made medical devices», — emphasized Igor Ivanov, General Director of the Federal State Budgetary Institution «VNIIIMT» of Roszdravnadzor.
The All-Russian Forum with International Participation «Circulation of Medical Devices «NOVAMED-2025» was held on November 10-11, 2025, in Moscow. The forum's sessions addressed key industry topics, including medical device registration, clinical trials, production inspections, mandatory labeling, materials and technologies, the future of AI in medicine, as well as regulatory frameworks and standardization.
