News

FAS (Federal Antimonopoly Service) Russia sent a warning to Roszdravnadzor to cancel the state registration of furniture as a medical device
By December 1, 2020, Rozdravnadzor needs to revise approaches to registering filing cabinets as medical devices and clear the state register of medical devices from household furniture FAS Russia issued a warning to the Federal Service for Surveillance in Healthcare (Roszdravnadzor) due to its inaction in resolving the issue of canceling the state registration of ... More
25.09.2020
Mikhail Mishustin expanded the list of medical goods that are not subject to VAT
Cars for transportation of disabled people have been added to the list of medical goods, the import and sale of which is exempt from value added tax (VAT). This resolution was signed by the Prime Minister Mikhail Mishustin. These are specially equipped passenger cars. They are equipped with lifts, handrails, special fasteners, security and warning ... More
21.09.2020
Roszdravnadzor issued the first registration certificate for a medical device within the Eurasian Economic Union with a primary inspection of production
Roszdravnadzor issued the first registration certificate for a medical device within the Eurasian Economic Union with a primary inspection of production for compliance with the requirements for the implementation, maintenance and assessment of the quality management system for medical devices, depending on the potential risk of their use, approved by the Decision of the Council ... More
17.09.2020
On September 11, Roszdravnadzor, together with the Russian Ministry of Health and the World Health Organization, will hold a press conference dedicated to World Patient Safety Day
On September 11, 2020 at 13:00, TASS will host a press conference dedicated to the Russian program of World Patient Safety Day, which is celebrated on September 17. The event is organized by Roszdravnadzor, the Ministry of Health of the Russian Federation and the World Health Organization. Alla Samoilova, head of the Federal Service for ... More
10.09.2020
World Patient Safety Day 2020
World Patient Safety Day September 17 Recognizing patient safety as a key health priority, on 25 May 2019, at its 72nd session, the World Health Assembly adopted resolution WHA72.6 “Global Patient Safety Action” and declared 17 September World Patient Safety Day. The goal of World Day is to raise global awareness of patient safety and ... More
28.08.2020
Roszdravnadzor withdrew medical equipment from the clinic, where the patients were diagnosed with a chakra disorder
The Territorial Authority of Roszdravnadzor for Moscow and the Moscow Region received information about poor quality medical care in a private clinic in the capital. The territorial authority has successfully completed a test purchase. A specialist of the Territorial Authority, under the guise of a patient, applied to Center Eliseeva LLC with complaints of poor ... More
24.08.2020
The world's first COVID-19 vaccine has been registered in the Russian Federation
Ministry of Health of the Russian Federation has issued a registration certification № ЛП-006395 dated August 11, 2020 for a vaccine to prevent the novel coronavirus infection COVID-19, which was developed by the National Research Centre for Epidemiology and Microbiology named after academician N.F. Gamalei of the Ministry of Health of the Russian Federation. Gam-COVID-Vac ... More
17.08.2020
Unified Pharmacopoeia of the EAEU approved
The Board of the Eurasian Economic Commission approved the EAEU Pharmacopoeia, which will become a single one for assessing the quality of medicines in five union countries. The EAEU Pharmacopoeia has become the second regional pharmacopoeia in the world. The document will take effect from March 1, 2021, according to the EEC website. Manufacturers of ... More
14.08.2020
On amendments to Appendices No. 1 and No. 2 to the Order of the Ministry of Health of the Russian Federation dated June 6, 2012 No. 4n “On approval of the nomenclature classification of medical devices”
The Federal Service for Surveillance in Healthcare informs that on August 10, 2020, the Ministry of Justice of the Russian Federation registered the order of the Ministry of Health of the Russian Federation dated 07.07.2020 No. 686n “On amendments to Appendices No. 1 and No. 2 to the order of the Ministry of Health of ... More
12.08.2020
For the attention of subjects of circulation of medical devices
In connection with the numerous applications from applicants on the issues of amending the documents contained in the registration dossier of medical devices registered in accordance with the Decree of the Government of the Russian Federation dated March 18, 2020 No. 299 “On Amendments to the Rules for State Registration of Medical Devices”, Roszdravnadzor reports ... More
30.07.2020