The Ministry of Industry and Trade admits the introduction of a ban on the state purchase of imported medical equipment in the presence of Russian counterparts
The Ministry of Industry and Trade of the Russian Federation is considering the possibility of introducing restrictions on government purchases of imported medical equipment in the event that domestic manufacturers with medical equipment competing in quality, functional characteristics and cost with foreign ones, by analogy with electronic products, are present on the Russian market. At ... More
Continuation of registration according to national regulations
To a request to the Eurasian Economic Commission for registration of a medical device in the manner prescribed by the legislation of the Russian Federation, provided that an application for examination or registration of this medical device was submitted before December 31, 2021, the following response was received: The draft Protocol on Amendments to the ... More
Manufacturers and importers will be obliged to report on the introduction of medical devices into circulation within 15 days
Roszdravnadzor has published a draft procedure for submitting information about medical devices, which will be required to transfer manufacturers or importers of specialized products. The data will be uploaded by market participants through their personal account on the Roszdravnadzor website, the list of information provided will include information on batches, batches, completeness, production date, expiration ... More
The Ministry of Health will supplement the standard of equipping clinical diagnostic laboratories
The Ministry of Health of the Russian Federation will update the Rules for conducting laboratory tests, approved by order No. 464n of May 18, 2021. The changes will affect the standard for equipping the clinical diagnostic laboratory: the department proposes to expand the list of medical device codes for a wider selection of equipment by ... More
Changes to the documents of the registration dossier
The following changes can be made to the registration dossier: Change applicant details: – on the reorganization of a legal entity; – about changing the name of a legal entity, – address of its location; – about changing the last name, first name and patronymic, the address of the place of residence of an individual ... More
Restrictions on the supply of ventilators and tomographs from abroad have been lifted in Russia
In Russia, restrictions on the purchase of foreign electrocardiographs, defibrillators, ventilators and a number of other medical products have been lifted. The corresponding government decree was published on the official Internet portal of legal information. Restrictions on the purchase of certain types of medical devices manufactured abroad were introduced in order to stimulate the production ... More
Mikhail Murashko advocated the introduction of mandatory labeling of medical devices
Russian Minister of Health Mikhail Murashko announced the introduction of mandatory labeling of medical devices. First of all, it should concern high-tech equipment and high-class medical devices of potential risk, the head of the Ministry of Health said. According to him, in order to combat counterfeit products, an information system will be created to identify ... More
The Ministry of Industry and Trade of the Russian Federation will introduce a point system for determining the country of origin for 22 types of medical products
The Ministry of Industry and Trade of the Russian Federation proposed to introduce a point system for determining the country of origin for 22 types of medical devices, including vacuum tubes and bilateral needles for taking venous blood, coronary stents and catheters. The order is planned to be updated from 2022, with the number of ... More
The Russian government has updated the rules for the import of non-registration Medical Devices
The government of the Russian Federation has approved changes to the rules for the import of medical products into Russia that are not subject to registration. The regulation requires market participants to enter data on each imported medical device into the automated information system (AIS) of Roszdravnadzor. The updates will take effect from March 1, ... More
Imports of PPE from China to Russia in 2020 amounted to $ 2 billion
Imports of personal protective equipment (PPE) from China to Russia in 2020 in monetary terms amounted to $ 2.01 billion. According to the Federal Customs Service, last year China imported $ 691 million worth of medical clothing; masks, half masks and respirators – for $ 659 million; shoe covers, gloves and other protective equipment – ... More