post-bg-425
calendary November 15, 2023

Roszdravnadzor plans to resume the work of the interdepartmental commission on inventory shortage of medical devices.

The regulation on the interdepartmental commission to determine the list of scarce medical devices for their accelerated registration was valid until September 1, 2023, but Roszdravnadzor intends to create the commission again.

Currently, the draft of order is at the stage of public discussion. If approved, the order will be in effect until January 1, 2025.

The draft provisions establish:

  • the procedure for determining inventory shortage of medical devices or the risk of their occurrence, as well as the criteria for including medical devices in the list of types of medical devices;

  • the procedure for organizing the work of the interdepartmental commission;

  • proposal form for inclusion of a type of medical device in the list of types of medical devices subject to circulation in accordance with the Peculiarities of Circulation of Medical Devices.

The commission is planned to include representatives of the Ministry of Health, the Ministry of Finance, the Ministry of Economic Development, the Ministry of Industry and Trade, the Federal Tax Service, the Federal Customs Service and the Federal Antimonopoly Service, as well as representatives of Roszdravnadzor.

Features of the circulation of medical devices in the event of their defects are presented in Decree of the Government of the Russian Federation dated 04/01/2022 N 552.

According to the document, if a medical device is recognized as defective, the registration period is reduced from 50 to 22 working days. Also, for such medical devices, the procedure for making changes to the registration dossier is simplified.

Currently, the List of defective medical products contains slightly less than 2000 type codes.

 

 

 

 

References:
  1. https://regulation.gov.ru/Regulation/Npa/PublicView?npaID=142668
  2. https://pharmvestnik.ru/content/news/Roszdravnadzor-predlojil-snova-sozdat-mejvedomstvennuu-komissiu-po-defekture-medizdelii.html
  3. https://www.roszdravnadzor.gov.ru/documents/79223

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