September 17 – World Patient Safety Day
September 17, 2019 marks the first time World Patient Safety Day was established on May 25, 2019 at the World Health Assembly. The goal of World Patient Safety Day is to increase global awareness of patient safety and promote overall solidarity between the professional community and the patients themselves, their relatives, and various patient organizations. ... More
Registration statistics for medical devices
We provide information on the registration of medical devices in Russia for 8 months of the current year. Since the beginning of the year, permits for the import of imported medical products have been issued for the purpose of their registration – 1833. Since the beginning of the year, 470 permits for conducting clinical trials ... More
Methodology for determining the amount of fees for the provision of services for the assessment of production conditions
Recall that in the process of registration of medical devices according to the rules of the EAEU, inspection of production is provided. You can familiarize yourself with the draft document on determining the amount of payment for such an inspection. A draft “On Approving the Methodology for Determining Fees for the Provision of Services for ... More
An in-person meeting of the international working group on in vitro diagnostic medical products created in the framework of the IMDRF Forum was held in Roszdravnadzor
An in-person meeting of the international working group on medical devices for in vitro diagnostics, created as part of the International Forum of Medical Device Regulators (IMDRF), chaired by the Russian Federation, was held on August 20 – 22, 2019 in Roszdravnadzor. The event was attended by representatives of 6 IMDRF member countries (Brazil, the ... More
RUSSIAN POST intends to sell medicines
The state-owned company Russian Post presented a transformation project for 2020-2027. According to a document aimed at coordination with interested ministries, Russian Post intends to transform its branches into hybrids of an alcohol market, pharmacy, bank and MFC, as well as educational and medical institutions. For this, the state-owned company will need almost 85 billion ... More
New national standards for medical and healthcare professionals approved
1. GOST R 58484-2019 “Surgical inactive implants. Hyaluronic acid implants. Standard guidance for determining the characteristics of hyaluronic acid as the basis for medical devices” was approved by order of Rosstandart of August 8, 2019 N 481-st. The standard applies to hyaluronic acid intended for use in biomedical and / or pharmaceutical purposes, including in ... More
On amendments to the list of non-taxable medical goods
Starting October 1, 2019, changes are being made to the list of medical goods whose sale on the territory of the Russian Federation and the import of which into the territory of the Russian Federation and other territories under its jurisdiction are not subject to (are exempted from) tax on value added ... More
Questions and answers update
Dear visitors, we have updated the section of the site “Questions and Answers” with new information. We hope that the materials presented will be useful to you. ... More
On August 15, Moscow hosted a joint public hearing of the Federal Service for Supervision of Health Care and the Territorial Authority of Roszdravnadzor in Moscow and the Moscow Region
On August 15, Moscow held a public discussion of the results of the law enforcement practice of the Federal Service for Supervision in Healthcare and the Territorial Authority of Roszdravnadzor in Moscow and the Moscow Region for the second quarter of 2019. The event was attended by over 200 representatives of medical and pharmaceutical organizations ... More
The Federal Service for Supervision of Healthcare announces the 16th meeting of the Forum held on September 16-19, 2019 in Yekaterinburg (hereinafter – IMDRF-16)
The forum was established in October 2011 in order to harmonize internationally the regulatory requirements for the circulation of medical devices (market access, quality control, safety and effectiveness, etc.). The Forum Steering Committee (IMDRF Management Committee) currently includes official representatives of 10 regulatory authorities of the participating countries, including: Australia, Brazil, the European Union, Canada, ... More