Collective appeal to the Government of the Russian Federation with a proposal to amend the Resolution on state registration of medical devices

The LUSOMI Association, the Medical Resources Union, the AIKKMP Association, the APF National Association and the PSKLD Association sent a joint appeal to the Government of the Russian Federation with a proposal to amend Resolution No. 1684 of 11/30/2024 "On Approval of the Rules for State Registration of Medical Devices"


Main offers:

✔️ To preserve the possibility of submitting documents on paper until the full launch of the electronic filing system through a single personal account of the applicant.

✔️ Allow authorized representatives of the manufacturer to certify electronic images of documents (including translations into Russian).

✔️ To accelerate the approval of the Administrative Regulations of Roszdravnadzor for the provision of public services for the registration of medical devices in accordance with the new Rules.


These measures will help to avoid bureaucratic difficulties and ensure uninterrupted registration of medical products in the interests of patients and manufacturers.