The Government of the Russian Federation has once again increased the list of medical devices implanted in the provision of free medical care to citizens (Decree of the Government of the Russian Federation No. 3053-r of December 31, 2018). The corresponding document was signed by Prime Minister Mikhail Mishustin last Tuesday.
The list was supplemented with a position with the code of the form 323330 “Prosthesis of the dura mater, based on a biopolymer composite.”
This year, seventeen applications were submitted, of which the Ministry of Health of the Russian Federation recommended only three medical devices for inclusion in the list: a set for vein sclerotherapy, coronary-venous and MRI-compatible pacemaker derivation (both Medtronic applicants), a dural prosthesis based on a biopolymer composite. Ultimately, only the dura prosthesis was approved for inclusion in the document.
To date, approximately ten names of the corresponding medical devices of foreign origin (USA, China, Germany) are registered in the Russian Federation. The most suitable product according to the description is a biomimetic matrix for the restoration of the dura mater NeoDuraTM. This prosthesis was registered in Russia three years ago (registration certificate RZN 2020/9917 dated April 9, 2020). Its manufacturer is Medprin Biotech GmbH (Germany, with production site in China).
The list of products implanted under the policy of compulsory medical insurance is updated with new positions almost every year. Last year, three products were included in the document. All are manufactured by Medtronic Inc. The list currently contains 376 titles.