Roszdravnadzor issued the first permission to use an unregistered medical device for in vitro diagnostics.
As part of the implementation of Decree of the Government of the Russian Federation No. 2026 dated November 24, 2021 “On unregistered medical devices for in vitro diagnostics”, Roszdravnadzor for the first time issued permission for the use of an unregistered medical device for in vitro diagnostics “A kit of reagents for high-throughput sequencing of human biological material in order to identify a wide range of hereditary monogenic diseases (ClinExom)”, produced by the National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I. Kulakov” of the Ministry of Health of the Russian Federation.
This unregistered in vitro diagnostic MD is intended for the detection of monogenic genetic conditions from the group of hereditary diseases using exome cell DNA analysis using high-throughput sequencing and according to the legislation can only be used in the medical center where the MD was manufactured.
According to the Decree, the permit is valid indefinitely but must be confirmed every 5 years from the date of granting the permit.
If we talk in general about the procedure for obtaining such permission, then the medical organization will need to submit:
- Application form
- Technical documentation
- Operational documentation
- Information confirming the possibility of using an unregistered MD for in vitro diagnostics for diagnosing diseases in accordance with the operational documentation of the manufacturer (medical organization)
- Information confirming the compliance of an unregistered medical device for in vitro diagnostics with the provision of paragraph 3 of the requirements for medical devices (justification of why it is more profitable to obtain permission for the use of medical devices rather than to register it).
- A copy of the composition of the expert council on issues of unregistered medical products for in vitro diagnostics.
- Copies of the minutes of the meetings of the expert council, at which the manufacturer’s technical documentation and the manufacturer’s operational documentation for this medical device were recommended.
- Photo of the general view of the medical device along with the accessories necessary for the intended use of the medical device.
- Inventory of documents.
The decision to grant a permit or to refuse to grant a permit is made by Roszdravnadzor within a period not exceeding 50 working days.
- Decree of the Government of the Russian Federation of November 24, 2021 N 2026 (as amended on August 26, 2022) “On unregistered medical products for in vitro diagnostics”