Main innovations
The Eurasian Economic Commission has expanded the list of grounds for suspending registration certificates for medical devices. This change is enshrined in EEC Council Decision No. 104 of September 9, 2026, which amends the current rules for registering medical devices.
The essence of the innovations
A key change was the introduction of an additional criterion for registration suspension. Now, the absence of a current production inspection report in the registration dossier can serve as grounds for this measure.
An important exception is provided for low-risk devices: this measure does not apply to medical devices of potential risk class 1, as well as to non-sterile devices of class 2a.
Protective mechanisms for applicants
The system for protecting the interests of producers provides the following guarantees:
- The suspension does not apply if an application for a scheduled inspection is submitted on time.
- It is necessary to provide notification with copies of the application and the agreement to the inspection organization.
- A 25-day waiting period has been established before a possible suspension
Circle of affected entities
The changes affect the following market participants:
- Manufacturers of medical devices of classes 2b, 2c and 3
- Authorized representatives of registered products
- Reference government bodies
- Organizations that carry out inspection of production facilities
Implementation deadlines
The regulatory act will enter into force 30 calendar days after its official publication, i.e., on September 28, 2026. This period is intended to allow market participants to adapt to the new requirements.
