Registration of suture material in Russia in 2026: requirements, stages and features

The registration of suture material in Russia is a mandatory procedure for bringing products to the market. Any surgical threads, needles with thread and other types of suture materials belong to medical devices and are subject to state registration with Roszdravnadzor. Without obtaining a registration certificate, a medical device cannot be legally used, sold or supplied to medical institutions in the territory of the Russian Federation.
In 2026, the procedure for registration of suture materials is regulated by the current rules for the treatment of medical devices and includes a comprehensive assessment of the safety, quality and effectiveness of products. Despite the relative simplicity of the design, suture is considered as a product that directly interacts with body tissues, which determines the increased requirements for its characteristics and evidence base.
The key stage of registration is to determine the risk class of a medical device. Suture material, as a rule, belongs to class 2b or 3, depending on the duration of contact with the body, the composition of the material and the field of application. Absorbable filaments, as well as products for long-term use, are more likely to fall into a higher risk class, which increases the amount of necessary testing and documentation requirements.
Registration of medical devices in Russia begins with the preparation of a registration dossier. At this stage, technical and operational documentation is formed, including a description of the product, its characteristics, composition and purpose. For suture materials, it is important to correctly describe the properties of the thread, the type of material, the strength parameters, the features of interaction with fabrics and the conditions of use.
Testing of a medical device is of particular importance in the process of suture registration. Technical and toxicological studies are mandatory. A toxicological assessment is critically important because the product is in contact with the internal tissues of the body. The biocompatibility of the material is assessed in accordance with safety requirements, including possible inflammatory reactions, toxicity, and degradation processes.
Technical tests are aimed at confirming the declared product characteristics. For suture materials, these are tear strength, elasticity, load resistance, as well as needle properties, if the product is supplied as a complete set. All characteristics must be confirmed by the test results and fully comply with the data specified in the documentation.
Depending on the type of product and the available evidence base, clinical trials may be required. However, for widely used materials, registration is allowed based on an analysis of clinical data and scientific literature, provided that the safety and effectiveness of the product can be confirmed without additional research.
After the tests are completed, a registration dossier is formed, which is submitted to Roszdravnadzor. Next, the medical device examination stage begins, which evaluates the completeness of the data provided, the correctness of the documentation and the compliance of the product with the established requirements. It is at this stage that key errors related to inconsistencies in documents or insufficient evidence are identified.
At the same time, the registration of suture material has a number of specific features. The product belongs to the category of products with direct contact with the body, therefore, the requirements for biological safety and stability of characteristics are particularly strict. Any discrepancies between the stated and actual parameters may lead to expert comments or refusal of registration.