Request a call
Application for medical device development service
Application for Medical Device QMS Service
Application for medical device registration service
Application for registration of medicines
Request for service of amendments to RC/RD








Request for marketing research service for MD and Pharmaceuticals








Application for technical and medical translation
Why is medical device registration necessary?

Registration of general-purpose medical devices

Назад
Registration confirms the legality of your product's circulation in the medical device market. The result of registration is the issuance of a registration certificate (RC) – an official document that grants the right to manufacture, import, store, and distribute the medical device. Having an RC enhances trust in the manufacturer and its products.
Registration of general-purpose medical devices is a mandatory procedure in the Russian Federation, confirming the safety, efficacy, and compliance of the medical device with established requirements. All general-purpose medical devices used in medical practice are subject to registration, except for those classified as single-use medical products.

Key aspects of general-purpose medical device registration.

The process of registering medical devices is complex and multi-stage, requiring thorough preparation, compliance with all established requirements, and in-depth knowledge of legislation and the specifics of medical devices.
The term "general-purpose medical devices" encompasses a wide range of items—from simple tools to complex technical equipment. This creates certain challenges in classifying and evaluating such products. Additionally, the classification of general-purpose medical devices may change over time due to technological advancements and the emergence of new types of products. This necessitates continuous updates to the regulatory framework and adaptation of registration procedures.
Types of general-purpose medical devices
01
Complex evaluation of general-purpose medical devices. Assessing the value of medical devices can be challenging due to the lack of unified methodologies and the diversity of products. Additionally, during registration and subsequent operation, it is necessary to consider technical specifications, as general-purpose medical devices are subject to wear and depreciation.
Key aspects of the registration object.
02
Specific requirements are applied to documentation, which may vary depending on the complexity of the medical device and the completeness of the provided documentation.
Documentation requirements
03
The timelines for registering general-purpose medical devices are established by law but may vary depending on the complexity of the procedure or change due to the adoption of new regulations. On average, the registration process takes from several months to a year.

Our company's experts successfully help clients minimize the risks of registration refusal and reduce the registration timelines for medical devices.
Procedure timelines
04
Get a cost estimate for the service

Other services within the MD registration

RZN Expert provides services for QMS analysis and implementation in compliance with ISO 13485 requirements for medical devices. We conduct an in-depth assessment of your processes, identify vulnerabilities, and develop tailored solutions for improvement.
Our experts will help you not only obtain ISO 13485 certification but also implement safe and effective procedures that meet global standards. We ensure full compliance with all medical device quality management system requirements, opening new opportunities for international market entry and increasing trust in your products.
RZN Expert also offers a full range of services for medical device registration with Roszdravnadzor.
m. Kropotkinskaya
Moscow, Voekhonka Street, 15
Our Medtech Business information resource on telegram. Legislative changes, market overview and science in the field of medical devices.