Roszdravnadzor approves new procedure for consultations during registration of medical devices
Roszdravnadzor has approved an order with an updated Procedure for consulting on state registration of medical devices. The document regulates the work of subordinate expert institutions and introduces a formalized consultation procedure, including a preliminary analysis and evaluation of the dossier before applying for registration. At the same time, a similar regulation, which had been in force since 2017, became invalid.
The consultation will cover the procedures related to the preparation and submission of the registration dossier, including an assessment of the completeness and correctness of the submitted materials, as well as an explanation of the requirements for testing and evidence base. It provides for the possibility of a preliminary analysis of the dossier, which actually introduces a mechanism for early detection of regulatory risks before the start of the main procedure.
The new procedure applies to all expert institutions involved in the Roszdravnadzor system. Previously, the order regulated consulting only for a limited number of organizations.
The draft order was submitted for public discussion at the end of March 2026. The explanatory note noted that the document was developed in order to comply with the Regulations on Roszdravnadzor and the Rules for State Registration of Medical Devices approved by the government in November 2024. The Regulations consolidate the authority of the department to organize such consultations and detail their conduct at the level of expert organizations.
In December 2025, Roszdravnadzor also submitted a draft administrative regulation on the provision of public services for the registration of medical devices, which detailed the procedure and timing of procedures, grounds for refusal and the composition of administrative actions. The document, developed on the basis of the rules for the registration of medical devices that entered into force in 2025, provides for shortened registration periods for certain product categories, regulates the introduction of changes to dossiers and conducting clinical trials, and also establishes the use of digital services when submitting applications.
In addition, in March 2026, the agency proposed to invalidate the orders establishing the form of registration certificate for medical devices in connection with the transition to electronic format. The new registration procedure provides for the digitalization of procedures and will be valid until the end of 2027, taking into account the extension of the transition period to the EAEU rules.