When planning the registration of medical devices in Russia, clinical trials are traditionally considered the most expensive and risky stage. They are most often perceived as the main source of expenses and delays. However, the practice of registering medical devices shows that the main financial and time losses occur much earlier, at the stages of preparing the registration dossier and forming a regulatory strategy.
Clinical trials are a formalized part of the medical device registration procedure. A program, scope of work, deadlines, and budget are determined in advance for them. With proper preparation, they rarely cause critical delays. Much more often, the project begins to become more expensive due to errors in the documentation for the registration of medical devices, incorrect determination of the risk class, and the lack of a well-thought-out evidence base.
Preparation of a registration dossier for Roszdravnadzor requires strict consistency of all documents. The technical description of the product, instructions for use, declared properties, and test results must form a single logical system. Any contradictions between documents are perceived by the regulator as a safety risk. In such cases, the examination is suspended, and the documents are returned for revision. This leads to repeated costs, increased registration time, and an increase in the overall cost of the project.
Significant costs are also generated at the stage of preclinical trials of medical devices. Technical, toxicological, and biological studies are mandatory for most products and directly depend on the risk class and purpose. If the test program is developed without taking into account the requirements of medical device registration legislation, the results obtained may be unsuitable for examination. As a result, some of the studies have to be repeated, and clinical trials are postponed.
A separate cost-increasing factor is returns and requests during the examination of the registration dossier. Even with formally fulfilled requirements, errors at the early stages lead to additional questions from Roszdravnadzor. Each such return means not only a delay in the medical device’s market entry but also indirect financial losses, including frozen investments, shifting commercial plans, and losing a competitive advantage.
As a result, clinical trials turn out to be not the most expensive stage of registration. The greatest costs are formed due to the lack of a unified medical device registration strategy, incorrect decisions at the start of the project, and attempts to optimize document preparation. These errors are rarely noticeable immediately, but they are the ones that make registration long, expensive, and unpredictable.
