Правительство РФ ввело обязательный досудебный порядок рассмотрения жалоб на действия Росздравнадзора с 1 июля 2021 года. Эксперимент по внедрению практики досудебного обжалования решений, предписаний и бездействия регулятора, в ходе которого обращения принимались в дистанционной форме через портал госуслуг, стартовал год назад, в августе 2020 года. Как следует из постановления Правительства РФ №663 от 28 апреля ... More
Opening hours during the may holidays
We inform you about the work schedule on holidays (May 1-10, 2021) 1 – 3, 8-10 may holidays and weekends. 4 – 7 may non-working days by the Decree of the President of the Russian Federation. ... More
Roszdravnadzor will test new forms of state control over the medical device market
The Ministry of Health of the Russian Federation presented an updated draft Regulation on state control over the market of medical devices. The new edition will increase the intervals of checks – they will be carried out once every 4-10 years for participants in the medical device market classified as moderate, medium and significant risk. ... More
EEC Council extends duty-free import of medicines and medical devices to fight coronavirus
The Council of the Eurasian Economic Commission (EEC) has extended the duty-free regime on the import of medicines and medical products to prevent and prevent the spread of coronavirus infection until June 30, 2022. The preferences for specialized medical devices were valid from March 2020, and then extended until September 2020 and March 2021. „On ... More
A company from Vyborg was fined 600 million rubles for evading VAT when importing medical equipment
Vyborg customs (a subdivision of the North-West Department of the Federal Customs Service of the Russian Federation) opened a criminal case under Part 2 of Art. 194 of the Criminal Code of the Russian Federation (evasion of customs payments) in relation to a company that imported medical equipment and declared it as a medical device ... More
The EEC Council approved a transitional period for the treatment of medical devices according to national rules until 2026
The Council of the Eurasian Economic Commission (EEC) approved amendments to the „Agreement on uniform principles and rules for the circulation of medical products.“ The changes relate to the transitional period and will come into force after the project is signed by representatives of all member countries of the Union. Amendments are supposed to be ... More
The SEZ „Technopolis „Moscow“ for 170 million rubles will launch the production of drugs for mesotherapy and biorevitalization
Subsidiary of the group of companies „Mesopharm“ – LLC „Mesoformula“ – will invest 170 million rubles in the production of drugs for professional and medical cosmetology. The plant will be built on the site of the special economic zone (SEZ) Technopolis Moscow, and its launch is scheduled for the third quarter of 2022. “The plant ... More
The profile committee of the State Duma approved the expansion of the powers of Roszdravnadzor to confiscate medical products
The State Duma Committee on Health Protection at a meeting on March 24 recommended that the deputies adopt in the first reading a bill on amendments to 323-FZ „On the basics of protecting the health of citizens in the Russian Federation.“ The proposed draft amendments regulate the right of Roszdravnadzor to make decisions on the ... More
Philips and Amiko signed an agreement on the production of MRI in the Moscow region
The Dutch manufacturer of medical equipment Philips and the Amiko group of companies signed an agreement to organize the production of magnetic resonance imaging (MRI) scanners on the basis of the JSC „Rentgenprom“ plant in the Moscow region. The volume of investments in the project has not been disclosed, the planned capacity is up to ... More
Replacement of blanks of registration certificates
Dear colleagues! Recently, we are very often contacted with the question: what to do if they did not manage to change the RU form issued before the entry into force of Order 1416 (The replacement should have been carried out before January 1, 2021) According to the information we have, all RUs that have not ... More