News Digest 07.07.2023 - 10.07.2023

Regulators

A project was submitted to the State for the extension of the national registration of medical works at the EEA level

The Protocol provides for an extension until 31 December 2025 of the possibility of applying for an examination or registration of a medical certificate in the manner provided for in the legislation of a State member of EEA. The protocol also provides for its provisional application from the date of signature, as set out in the explanatory note to the document. The provisions of the document are intended to maintain national medical registration systems to eliminate the risk of their deficit.

Source: https://pharmvestnik.ru/content/news/V-Gosdumu-vnesen-proekt-o-prodlenii-nacionalnoi-registracii-medizdelii-na-urovne-EAES.html

The Ministry of Health has developed a list of medical and curative foods that can be purchased with trademarks

According to the document, the inclusion of medical products and specialized health products in the list will be considered by an inter-ministerial commission. It is composed of representatives of the Ministry of Health, the Ministry of Commerce, FAS, the Department of Health, the Department of Public Health and the Federal Treasury.

The medical unit for listing should meet the following criteria:

  • To be registered in Russia.
  • To have an opinion from the Chief Emergency Specialist of the Ministry of Health on the disease that is cured with the use of medical equipment, that it cannot be replaced by another medical unit used to treat patients with the same disease.
  • There should be no decision by the Rhoszdor to suspend its use or to remove it.

Source: https://medvestnik.ru/content/news/Minzdrav-razrabotal-poryadok-formirovaniya-perechnya-medizdelii-dlya-zakupok-po-tovarnomu-znaku.html

In Gosduma, it was proposed to establish a special rental service, where State clinics could rent innovative foreign equipment.

Ghosduma ' s Deputo Airat Farrahov has proposed the establishment of a special rental service where government clinics can rent innovative, expensive equipment, including foreign IWL machines. The landlords may be commercial clinics where the equipment is available.

Source: https://medvestnik.ru/content/news/V-Gosdume-predlojili-sozdat-arendnuu-slujbu-s-inostrannymi-IVL.html


Market developments

Iran will help Russia replace Western medical equipment

Iran will assist Russia in replacing Western medical equipment, as the Islamic Republic has made a stake in science and medicine since the imposition of the sanctions. Ura.ru stated that the Director of the Centre for Legal Regulation of Federative Relations of the Faculty of Foreign Affairs of the RANHIG Dmitri Episin.

" As I know, several of our Ural corporations are negotiating with Iranian business structures on joint production of medical equipment " , he said. It is also noted that the supply of such equipment will begin after the complete launch of the north-south transport corridor. On 31 May, the Rector of the Moscow State Medical and Tomatological University of A. I. Evdokimov, the Chief Medical Officer of the Ministry of Health, Oleg Yanušević, stated that the percentage of private medicine in Russia was quite high, but it was not linked to the State ' s failure to finance dental medicine.

Source: https://www.gazeta.ru/social/news/2023/07/08/20832134.shtml


Events

Seminar on " Review of the Public Registration of Medical Products within EEA "

FGB " WNIIMT "

Date of 20 July 2023. Participation format online.

VNIIMT FGB specialists The Starfleet will introduce you to the features of the procedure for the registration of medical items in the national registration system, as well as the major errors.

You may ask your questions in advance, in completing the application for participation or during the event. Our specialists will give you exhaustive answers.

Cost of participation of one participant 24 000.00 roubles.

Registration application: http://www.vniiimt.ru/zayavka/fis/?sn=seminar20jul

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