News Digest 30.08.2023-01.09.2023
Regulators
Overview of legal changes effective September 1, 2023
Marking for wheelchairs, skin antiseptics and dietary supplements will become mandatory. The regulatory initiative is aimed at controlling the turnover of products - a number of departments will monitor the pace of market legalization, a decrease in sales of products with an expiring shelf life and inadequate quality.
Also, from September 1, a notification procedure for the import of medical devices for the state registration procedure or changes to the current dossier, including testing, will begin to operate. In fact, the regulation was introduced by a letter from Roszdravnadzor a year ago, in August 2022, but it has only now received full regulatory formalization. The applicant will have to submit data on the number of products, names, batch number and series, configuration, expiration date, information about the manufacturer, authorized person and registration certificate data to the AIS of Roszdravnadzor through the public services portal, if products are imported to make changes to the current dossier.
Medical gloves will be subject to mandatory labeling in the spring of 2024
The Ministry of Industry and Trade of the Russian Federation intends to include medical gloves in the list of mandatory labeling. It is assumed that the product movement monitoring system will work from March 1, 2024, and all types of medical gloves will fall under it. The stage of a voluntary experiment, which took place in the case of other types of medical devices, before the introduction of mandatory labeling of medical gloves is not expected, however, market participants, on their own initiative, can start labeling products ahead of schedule.
Ethical and biomedical expertise will be carried out for the use of BMCP
The Ministry of Health of the Russian Federation presented a draft government decree on approving the procedure for the circulation of biomedical cell products (BMCP), specially produced for a particular patient directly in a medical organization. For the production and use of BMCP, ethical and biomedical expertise must be carried out, the document says. If adopted, the resolution will enter into force on September 1, 2024 and will be valid until September 1, 2030.
Market news
Nova-Health will launch the production of medical devices for dentistry in Tomsk for 17 million rubles
The new resident of the special economic zone (SEZ) "Tomsk" company "Nova-Health" intends to organize the production of medical devices for dental purposes. Investments in the project will amount to 17 million rubles, the project implementation period is 5 years.
Other
The arbitration upheld the decision on collusion in the supply of medical devices in Udmurtia
The Arbitration Court of the Udmurt Republic upheld the decision on collusion between the supplier of medical devices Amsel and the individual entrepreneur Andrey Petukhov, reducing the fine under the article on violation of competition to 20,000 rubles. The regulator accused the entrepreneur and the company of dividing the market at tenders from 2019 to 2021 with a total check of 243 million rubles.
New registered medical devices
We publish a list of new medical devices registered from 25.08.2023 to 01.09.2023
https://asiamc.ru/uploads/blogs/2023-09-01/medregs_20230901.pdfNews
