Professional Quality Management System Certification services
Expert support in Quality Management System implementation, medical device registration, and tailored documentation services, ensuring streamlined processes and successful outcomes
OUR
Services
Medical Device Certification and Registration Services:
Medical Device Registration in Russia
Holding a registration certificate allows the medical device to be marketed within Russia
Medical Device Registration in EAEU
The presence of a registration certificate allows the medical device to be marketed in the territory of EAEU
Making changes to the registration dossier
Procedure for making changes to the registration dossier
Making changes to the registration certificate
Procedure for making changes to the registration certificate
Registration of medical devices for IVD
Registration of in vitro diagnostic devices (IVD) is a one-step process
Duplicate of the registration certificate
Issuance of a duplicate registration certificate for a medical device
Other services
A full range of services for the registration of medical devices
Compliance with Quality Management Systems (QMS) standards enhances quality, reduces defect levels, and ensures the fulfillment of the fundamental requirement for medical devices – achieving a benefit from their use that outweighs potential risks. To meet this requirement, medical devices must adhere to criteria for quality, safety, and effectiveness.
Until recently, the implementation of QMS by domestic producers of medical devices (MD) and companies providing technical maintenance for medical equipment was voluntary. However, at this point, the following regulatory documents have been developed and adopted, mandating the compulsory implementation of QMS:
- The Government of the Russian Federation’s decree dated 09.02.2022 №135 mandates Russian medical device (MD) manufacturers to develop and implement a Quality Management System (QMS) in accordance with GOST ISO 13485-2017. This requirement is compulsory for manufacturers of sterile MDs of risk class 2a, and all MDs of risk classes 2b and 3. For other manufacturers, this requirement is advisory – those who have implemented and passed the QMS compliance check can make changes to their registration dossier through a notification procedure without undergoing an examination of quality, efficacy, and safety.
- The Government of the Russian Federation’s decree dated November 30, 2021, № 2129, establishes the necessity for organizations providing technical maintenance of MDs, excluding class 1 risk MDs, to implement a QMS in accordance with GOST ISO 13485-2017 requirements.
- The Eurasian Economic Commission’s decision dated November 10, 2017, N 106, mandates the implementation of a QMS for MD manufacturers planning to register MDs according to the EAEU rules.
Experience shows that the absence of an implemented QMS leads to increased regulatory scrutiny during registration and licensing procedures. Lack of a QMS compliant with GOST ISO 13485-2017 and/or Decision № 106 may be considered a lack of necessary conditions for the manufacturing of MDs / technical maintenance of medical equipment.
Our company offers professional assistance to MD manufacturers in addressing practical tasks related to the registration of medical devices. With expert knowledge and extensive experience in practical registration and certification of medical devices in Russia, and through successful collaboration with major foreign and Russian companies, we have been successfully implementing projects since 2005.
The foundation of our company’s success is built on unwavering principles of honest and transparent business practices, high-quality work, professionalism, client focus, adaptability to changes in existing conditions and legislation, and most importantly, the value of human relationships. LLC “SSMK” aims to achieve high standards at every stage of work, as evidenced by the success and scope of projects we have successfully implemented, the dynamic development of our company, and its reputation in the market. We provide a full range of services from auditing a manufacturer’s existing documentation and evaluating it according to QMS requirements, ISO 13485, GOST 2.114.-2016, 11n, RF Government Decree 1416, and other regulatory requirements applicable to MDs, to providing comprehensive “turnkey” medical device registration services.
Our Advantages
The cost of our services is calculated individually and depends on the volume of required work. For a cost estimate, contact us in any way convenient for you for a free consultation.
Send us a request, and our registration specialist will analyze the existing data, select the optimal registration algorithm, assess the volume of work required for dossier preparation, and send you a commercial offer.
- In-House Expertise: Our team includes technical, clinical, and registration specialists with expert knowledge and experience in QMS verification, MD registration, and documentation development according to QMS, norms, and current legislative requirements. Our specialists are continually enhancing their knowledge through training and participation in educational conferences.
- Personalized Approach: We offer a tailored approach that allows you to delegate most of the process management to us. Each project is assigned to a specialist who oversees all stages of work and provides consultancy on all aspects of the services offered.
- Comprehensive Services: Our services range from auditing existing documentation and comprehensive readiness assessment for the registration procedure, to preparing a complete dossier “turnkey”. This includes specific services like organizing tests, developing technical and operational documentation according to QMS and current legislation, as well as full dossier preparation for examination.
- Extensive Experience: We have years of experience collaborating with major testing-laboratory centers and medical institutions conducting technical, toxicological, and clinical trials, allowing us to organize all types of required tests with minimal resource expenditure.
- Cost Reduction: We help you significantly reduce registration costs by shortening the time frame, avoiding repeated applications, and conducting research and tests of your product under the most favorable conditions.
- Direct Collaboration: We have direct partnerships with translation and notary offices for urgent translations and document notarization as per regulations, and with agencies organizing overseas testing (visa arrangements, ticketing, and accommodation in the destination country).
- Complex Issue Resolution: Assistance in addressing complex comments to the registration dossier, including those resulting from state control.
- Commitment to Results: We ensure all projects are brought to a successful conclusion.
Consultation Request:
To evaluate the cost of registering medical devices, please fill out this brief questionnaire and receive a 10% discount on our services.