News Digest 21.07.2023 - 24.07.2023
Regulators
Putin extended the ban on the export of foreign medical equipment abroad for two years
Restrictions on the export of products on the list of the government will be valid until the end of 2025.
In the spring of 2022, the government banned the export of foreign medical devices from the country. Such a measure was introduced against the backdrop of sanctions in order to prevent a shortage, the government explained. The ban did not apply to products from Russia with a certificate in the ST-1 form and deliveries to the EAEU countries. Then the profile decree was extended until the end of 2023.
The list initially included more than 200 items, including sophisticated medical equipment, then the restrictions were partially relaxed.
Source: http://publication.pravo.gov.ru/document/0001202307200006
The State Duma extended the national registration of medical devices at the EAEU level
The State Duma adopted a law on the ratification of a protocol extending the national registration of medical devices. The document will be valid until the end of 2025.
The document was submitted to the State Duma by the government in early July. It provides for the extension until December 31, 2025 of the possibility of filing an application for examination or registration of a medical device in the manner prescribed by the legislation of a member state of the EAEU. The protocol also provides for its temporary application from the date of signing, the explanatory note to the document says. The provisions of the document are aimed at maintaining national systems for registering medical devices in order to eliminate the threat of their shortage.
The Ministry of Industry and Trade will ban only two types of imported ventilators for public procurement
The Ministry of Industry and Trade of Russia is ready to limit the ban on the purchase of artificial lung ventilation (IVL) devices on the state order market by two positions - an intensive care device for newborns and adults, as well as a general-purpose intensive care device. The department presented this position at a meeting with the medical community and charitable foundations. Devices that have caused the greatest concern among the patient and medical communities, including devices for home use, will not be included in the list.
The scoring system of localization will be extended to nutrient media for microorganisms
The Ministry of Industry and Trade intends to introduce a point system for the localization of nutrient media for growing microorganisms. The media market in the department is estimated at 9.6 billion rubles, of which a quarter falls on government orders. Russian manufacturers occupy less than a third of it.
Amendments are planned to be made to Decree of the Government of the Russian Federation No. 719 dated July 17, 2015. The scoring system will take into account capital intensity, added value, prospects and criticality of media production technologies to more accurately determine the level of production localization in Russia.
At the end of December 2022, the Russian Government approved a point system for determining the country of origin for 24 types of medical devices. The changes affected lubricant gels, alcohol, medical, sorption wipes, dressings, wound, atraumatic, hydrogel, antimicrobial dressings, disposable test tubes and bilateral needles for taking venous blood, instruments for microsurgery, syringes-injectors, balloon catheters, care products stoma, osteosynthesis kits, and drug-coated and non-coated coronary stents.
Other
National Medical Research Center for Radiology will develop research projects in the Kaluga Region
The Government of the Kaluga Region and the National Medical Research Center for Radiology signed an agreement on cooperation in the field of healthcare. The Parties will create conditions for the development of joint research projects.
In addition, the NMIC and the government of the region agreed to improve the quality of medical care provided in medical organizations subordinate to the Ministry of Health of the Kaluga Region.
The agreement was signed at the International Expert Forum on Nuclear Medicine of the BRICS countries. The event takes place in the science city at the Medical Radiological Research Center named after. A.F. Tsyba.
At the forum, participants discuss a number of important issues of the industry - the status and prospects for the development of diagnostic equipment for nuclear medicine in the BRICS countries, trends in the field of radionuclide diagnostics, and promising areas of radionuclide therapy.
The International Expert Forum on Nuclear Medicine of the BRICS countries is taking place on July 20-21, 2023 in Obninsk. The event is attended by representatives of Russia, Brazil, India, China and South Africa.
News
