News

FOR LOW-RISK MI MANUFACTURERS, THE IMPLEMENTATION OF A QUALITY MANAGEMENT SYSTEM WILL BE VOLUNTARY
The Ministry of Health of the Russian Federation presented a draft requirements for the implementation, maintenance and assessment of a quality management system for medical devices, depending on the potential risk of their use. The introduction of the system will be voluntary for manufacturers of medical devices of the first and non-sterile medical devices of ... More
28.07.2021
THE MINISTRY OF HEALTH OF THE RF ALMOST TWICE EXPANDED THE LIST OF MI FOR RE-EQUIPMENT OF THE PRIMARY LINK
The Ministry of Health of the Russian Federation has made amendments to the list of equipment for equipping and re-equipping medical organizations during the implementation of regional programs for the modernization of primary health care, expanding the list from 121 to 212 items. In particular, the updated list includes medical furniture, equipment for physiotherapy and ... More
27.07.2021
From July 1, 2021, the Regulation on federal state control (supervision) over the circulation of medical devices comes into force
Federal state control is exercised by Roszdravnadzor and its territorial bodies. The objects of control are: the activities of legal entities and individual entrepreneurs in the field of circulation of medical devices; the results of the activities of the controlled persons; buildings, premises, structures and equipment to which mandatory requirements are imposed. Objects of state ... More
08.07.2021
Changes to the list of preferential taxation 10%
From October 1, the lists of medical products that must be subject to VAT at a rate of 10% will be updated In the list of preferential medical goods according to OKPD2, for example, it will be specified that the code 32.50.50.000 for MI is used when it is on the registration certificate. This is ... More
29.06.2021
On June 10-11, 2020, the XXIII Annual All-Russian Conference “State Regulation in the Sphere of Circulation of Medicines and Medical Devices – PharmMedCirculation – 2021”
On June 10-11, 2021, the XXIII Annual All-Russian Conference “State Regulation in the Sphere of Circulation of Medicines and Medical Devices – PharmMedObservation – 2021” was held online, in which more than 1300 participants from Russia, Kazakhstan, Armenia, Kyrgyzstan, the Netherlands took part, Switzerland, France and the USA. At the plenary session, the Minister of ... More
16.06.2021
THE STATE DUMA APPROVED AMENDMENTS ON OPERATIONAL WITHDRAWAL OF NON-CONDITIONAL MEDICAL PRODUCTS
Deputies of the State Duma of the Russian Federation in the third, final reading adopted amendments to 323-FZ “On the basics of public health protection in the Russian Federation” concerning the circulation of medical products and the powers of Roszdravnadzor to seize falsified, substandard and counterfeit products. The specific regulations for the withdrawal of substandard ... More
11.06.2021
The Government of the Russian Federation has added the list of medical devices subject to preferential taxation
The Russian government has added four new categories to the list of medical devices subject to preferential value added taxation (VAT). The list includes culture media and analytes for in vitro diagnostics, urological products, and metal containers for hazardous medical waste. Amendments were made to the RF Government Decree No. 688 of September 15, 2008 ... More
10.06.2021
“On conducting an experiment on the marking of certain types of medical devices with identification means in the territory of the Russian Federation”
From August 1, 2021 to February 28, 2023, it is proposed to conduct a voluntary experiment on labeling in Russia with means of identification of orthopedic shoes, hearing aids, coronary stents and absorbent products used for incontinence The purpose of the experiment is to test the completeness and sufficiency of labeling mechanisms to counter the ... More
08.06.2021
Chinese company Anke introduced a 1.5 T high-field tomograph to the Russian market
The Chinese manufacturer of medical imaging equipment Anke has introduced a magnetic resonance imaging (MRI) scanner under the SuperMark brand with a field induction of 1.5 T to the Russian market. Roszdravnadzor issued a registration certificate for a medical device on May 18, 2021, the holder of the RU is the Russian distributor of Anke ... More
28.05.2021
Roszdravnadzor signed a Memorandum of Understanding with the Ministry of Health of the United Mexican States
On May 20, 2021, the head of the Federal Service for Surveillance in Healthcare Alla Samoilova signed an online Memorandum of Understanding between Roszdravnadzor and the Ministry of Health of the United Mexican States represented by the Federal Commission on Protection against Health Risks (COFEPRIS). The provisions of the Memorandum provide for the exchange of ... More
26.05.2021