All in one service provider
Center of Certification and Registration of Medical Devices
Our experts guide you smoothly through:
- Conformity assessments
- Normative documentation development
- Mandatory product testing
- Toxicology and clinical evaluations
- Roszdravnadzor applications
Our
Services
Obtaining Medical Device Registration
Modifying the Registration Dossier
Duplicate registration certificate
Amendments to the registration certificate
Other services
Today, representatives of the medical industry strive to supply modern and competitive equipment and products to the Russian market quickly and with minimal costs. The strategic goal of our company is to provide professional assistance to manufacturers in solving practical problems in registering medical products and achieving advantages in the Russian market.
Possessing expert knowledge of the practice of registration and certification of medical products in Russia, as well as experience of cooperation with the largest foreign and Russian companies, the Certification and Declaration Center Certification Authority has been successfully implementing projects since 2005.
In 2009, following a recommendation from the Federal Agency on Technical Regulating and Metrology, the Certification and Declaration Center was restructured to establish an independent consulting company, the “Medical Device Certification and Registration Center”.
Expert Guidance for Medical Device Registration
The consulting company “Medical Device Certification and Registration Center”(CCRMD) provides advisory and methodological services for conducting technical, toxicological and clinical trials, as well as conformity assessments and development of the necessary regulatory documentation required for registering medical devices with Roszdravnadzor. Our company’s process-oriented approach allows us to organize medical device registration in a flexible manner, focused on continuously improving the quality of services provided, reducing costs, and most importantly, meeting client needs.
Key Consulting and Methodology Services
- Conformity assessments and preliminary review of applicant documentation
- Development and/or approval of medical device regulatory documentation
- Organization of required medical device testing
The consulting and methodology services offered by our company are structured into distinct projects. These projects follow a project management methodology that assists our leadership team in making informed, validated decisions, performing work quickly and qualitatively with lower costs, and maintaining full transparency into each ongoing project.
Our Foundation is Trust and Expert Service
At the core of our company’s success are timeless principles of honest and transparent business practices, high-quality work, professionalism, customer-centricity, adaptability to changing conditions and regulations, and above all, valuing human relationships. The “Medical Device Certification and Registration Center” strives to achieve excellent standards at all stages of our work. This commitment is evidenced by the success and high efficiency of our projects, the dynamics of our company growth, and our strong reputation in the industry.
LEGISLATION OF THE EURASIAN ECONOMIC UNION
Makes it possible to circulate medical devices on the territory of all EAEU countries (in case of a positive decision and recognition of the examination conclusion by all EAEU member countries of your choice).
Currently, the EAEU includes five countries: The Republic of Armenia, The Republic of Belarus, The Republic of Kazakhstan, The Kyrgyz Republic, The Russian Federation.
The main legal acts regulating the registration of medical devices in EAEU:
- Agreement on common principles and rules for the circulation of medical devices (medical products and medical equipment) in the framework of the Eurasian Economic Union from 23.12.2014
- Decision of the EEC Council No. 46 “On the Rules for registration and examination of the safety, quality and effectiveness of medical devices”
NATIONAL LEGISLATION OF THE RUSSIAN FEDERATION
Makes it possible to circulate medical devices only on the territory of the Russian Federation.
The main national legal acts regulating the registration of medical devices in Russia:
- Federal Law N 323-FZ “On the Basics of Protecting the Health of Citizens in the Russian Federation”
- Decree of the Government of the Russian Federation N 1416 ” On Approval of the Rules for State Registration of Medical Devices “
- Decree of the Government of the Russian Federation N 552 “On approval of the specifics of circulation, including specifics of state registration, of medical devices in the event of their defectiveness or the risk of defectiveness in connection with the introduction of restrictive measures of an economic nature in relation to the Russian Federation“
- Decree of the Government of the Russian Federation N 430 “On the peculiarities of the circulation of medical devices, including state registration of a series (batch) of a medical device”