The procedure for the import of medical devices for the purposes of registration in 2023.

On May 2, 2023, the Ministry of Health of the Russian Federation approved the procedure for importing medical devices for the purposes of state registration. According to Order No. 201n, the applicant must notify Roszdravnadzor of the intention to import medical devices in the electronic form for the purposes of state registration.

The notification procedure for the import of unregistered medical devices for their registration was introduced in the summer of 2022. From that moment, it was no longer required to obtain an import permit from Roszdravnadzor (Information letter No. 04i-879/22 dated 08.08.2022). The simplification of the import procedure was carried out as part of the “regulatory guillotine” and Decree of the Government of the Russian Federation No. 336 of March 10, 2022, which established the specifics for conducting inspections in 2022.

However, until now, the relevant changes have not been made to Order No. 661n “On Approval of the Procedure for Importing Medical Devices into the Russian Federation for the Purposes of State Registration”. The approved Order No. 201n a year later replaced the previously existing Order 661n.

To obtain permission to import an unregistered medical device, the applicant must submit a notification signed with an enhanced qualified electronic signature through the public services portal. The order also determines the amount of information that must be provided about the medical device and the applicant:

  1. The name of the medical device, indicating the model, version, configuration, accessory, quantity, serial number, series number, batch number, production date, expiration date
  2. Information about the Registration Certificate (if the notification is submitted as part of the amendment)
  3. Information about the medical device application
  4. Name of the applicant and information about the legal entity
  5. Name of the manufacturer, his address and manufacturing site address
  6. Information about organizations where testing is planned

Roszdravnadzor informs the applicant about the receipt of the notification in electronic form within 1 business day and maintains a register of received notifications.

If it is necessary to import an additional number of samples, the notification is sent again.

Order 201n comes into force on September 1, 2023 and is valid until September 1, 2029.