News digest 30.06.2023 - 03.07.2023
Regulators
Amendments have been made to the List of standards for medical devices of the EAEU
The medical device is undergoing preclinical studies, Interfax reports citing Natalia Nichai, a researcher at the center.
The amendments provide for the introduction of data on 16 new versions of standards adopted in 2020-2022, previously included in the list.
We are talking, for example, about a number of standards of the series:
- GOST ISO 10993 "Medical Devices. Evaluation of biological effect of medical devices"
- GOST IEC 62304-2022 "Medical devices. Software. Life cycle processes"
- GOST ISO 14971-2021 "Medical devices. Application of risk management to medical devices"
- GOST R ISO 15223-1-2020 "Medical devices. Symbols used in the marking of medical devices, on labels and in accompanying documentation. Part 1. Basic requirements."
- GOST R IEC 60601-2-47-2017 "Medical electrical products. Part 2-47. Particular safety requirements with regard to basic functional characteristics for ambulatory electrocardiographic systems".
The start of the document is 29.12.2023.
Source: https://docs.eaeunion.org/docs/ru-ru/01440331/err_29062023_15
The Ministry of Industry and Trade will adjust the requirements for industrial clusters
The Ministry of Industry and Trade has proposed to update the requirements for industrial clusters and specialized organizations of industrial clusters. In particular, the changes will allow for the inclusion in their composition of industrial enterprises specializing in the provision of production services, including high-tech services.
Market News
NPO "Scanner" invested 70 million rubles in localization of ultrasound "RuScan" in Moscow
Scientific and Production Association (NPO) "Scanner" has localized the production of expert ultrasound under the brand "RuScan" (Russian version of Samsung Medison) at the facilities of the special economic zone (SEZ) "Technopolis "Moscow". The capacity of the enterprise will amount to 2 thousand devices per year, the volume of investments is estimated at 70 million rubles.
"Pharmstandard-Medtekhnika" achieved the cancellation of offset for the capital's blood service for 5.3 billion rubles
The Department of Health of Moscow (DZM) has canceled the offset for the supply of medical products for the city's blood service for a total of 5.277 billion rubles. The tender was announced in March 2023, but its terms were appealed by Pharmstandard-Medtechnika to the Federal Antimonopoly Service (FAS). The FAS agreed with the company's arguments that, according to the protectionist decree of the Russian Government No. 620, it is prohibited to combine different types of medical devices into one lot, and issued a prescription to eliminate violations. Faced with this conflict, Moscow Mayor Sergei Sobyanin asked the Ministry of Industry and Trade to amend the list, taking offsets out of the brackets of the norm. The Ministry promptly developed the amendments, but they were not approved by the end of June 2023. As a result, in order to fulfill the FAS order, the DZM first excluded 13 out of 14 types of medical products from the offset, reducing the contract price to 367 million rubles, and extended the acceptance of bids, and then canceled the tender altogether.
Other
Australia has developed smart glasses to diagnose diabetic foot disease
Australia has developed "smart" mixed reality glasses with holographic features. They are expected to revolutionize the treatment of foot wounds in people with diabetes and vascular disease in hard-to-reach and remote areas and reduce the number of lower limb amputations.
News
