In Russia, the simplified procedure for registration of medical devices and individual medicines has been extended

At the end of December 2025, the Government of the Russian Federation decided to extend the simplified procedure for state registration of certain medicines and medical devices. The relevant resolution No. 2158 of December 26, 2025 fixed new terms of temporary regulatory mechanisms previously introduced to ensure the sustainability of the healthcare system. According to the document, simplified registration procedures for individual medicines have been extended until January 1, 2036, and for the most in-demand medical products until December 31, 2028. At the same time, the validity periods of previously issued registration decisions have been adjusted, which allows the legal circulation of products to continue without the need for urgent completion of the full registration procedure. The simplified procedure provides for shorter time periods for reviewing documents and a more flexible approach to the composition of the registration dossier. At the same time, it does not eliminate the key requirements for product safety, quality and efficiency.
Medical devices and medicines registered in this format are still undergoing examination, and the decision on the possibility of applying a simplified procedure is made by a special interdepartmental commission. It includes representatives of relevant federal agencies, including the Ministry of Health, Roszdravnadzor and other agencies. It is important to note that the simplified procedure is not universal and does not automatically apply to all drugs and products. It is applied selectively and does not replace the standard system of state registration.
The extension of the deadline means that market participants still have the opportunity to use the simplified mechanism in cases stipulated by law, without interrupting the supply and circulation of socially significant products. At the same time, the requirements for a valid registration certificate remain unchanged. Without registration, medicines and medical devices cannot be legally produced, imported, sold or used in medical practice.