News Digest 01.09.2023-04.09.2023
Regulators
From September 1, 2023, standards in the field of medicine and healthcare came into force
- GOST IEC 62304-2022 "Medical products. Software. Life cycle processes";
- GOST R ISO 22367-2022 "Medical laboratories. Application of risk management in medical laboratories";
- GOST R ISO 80369-1-2022 "Small diameter connectors for liquids and gases used in healthcare. Part 1. General requirements";
- PNST 777-2022 "Artificial intelligence systems in clinical medicine. Part 10. Life cycle processes";
- GOST R 70478-2022 "Software as a medical device. Application of a quality management system";
- GOST R ISO 14155-2022 "Clinical trials of medical devices involving human subjects. Good clinical practice";
- GOST R ISO 80369-20-2022 "Small diameter connectors for liquids and gases used in healthcare. Part 20. General test methods."
PNST - preliminary national standard according to GOST R 1.16-2011.
Quotes from GOST R 1.16:
5.1 Pre-standards are used in the production and launch of fundamentally new (innovative) types of products, when introducing new testing and measurement methods, when transitioning to new methods of production management, when organizing new (innovative) technological processes and other justified cases.
5.2 Pre-standards can be applied directly or indirectly by developing organizational standards and technical documents (for example, technical specifications) based on them.
5.4 References to the pre-standard are not allowed in the national standards of the Russian Federation and codes of practice, as well as in the fundamental national standards of the Russian Federation.
When making references to prestandards in organizational standards, technical specifications, and other regulatory and technical documents, it is recommended to take into account the temporary nature of prestandards and the resulting need to replace these references when the reference prestandard is cancelled.
5.5 It is not allowed to update the current pre-standard by revising it or developing a change to the pre-standard. In exceptional cases (if there are typos, errors or other inaccuracies), it is allowed to update the current pre-standard by amending it.
6.1 Interested federal and other executive authorities, legal entities and individuals, no later than four months before the expiration of the established validity period of the pre-standard, send reviews containing information on its practical application and comments to the federal executive body in the field of standardization, as well as to the developer of the pre-standard. and proposals on the content of the pre-standard and an opinion on the feasibility (inexpediency) of its approval as a national standard of the Russian Federation.
Source: https://t.me/reg_devices/12619
On September 1, 2024, changes to the Regulations on licensing the technical maintenance of medical devices came into force
RF PP dated August 12, 2023 No. 1332 will supplement the list of groups of medical devices subject to maintenance, and also contains an important note that all manufacturers and UPPs carrying out medical maintenance were waiting for, namely:
"Provided that if the manufacturer of medical devices or medical devices of foreign manufacture, information about which is contained in the registration dossier for the medical device, carries out maintenance only of the medical devices produced by him, he has the right to use measuring instruments, and (or) technical means, and (or) equipment provided for its regulatory, technical or operational documentation, without taking into account the requirements of this list."
Source: https://t.me/promedizd/100
Market news
Production of reagents for hematology analyzers has opened in Russia
The grand opening of the Russian production site of BioMedical Production LLC (“BMP”) of the international holding Erba Group took place in Dubna on August 29. The plant began producing reagents for hematology analyzers; in the future, the full-cycle enterprise plans to expand its production space and range of products. The plant complies with the international standard GMP ISO-13485 and was built using technologies from the parent Indian company Transasia Bio-Medicals Ltd. The new enterprise created 25 jobs, investments in the project amounted to 54 million rubles.
The launch of a new production site in Dubna will be a significant step in import substitution and will contribute to the development of medical laboratory diagnostics at the national level. Having started the production of reagents for hematological analyzers, in the future BMP plans to expand its production space and range of products, localizing the production of reagents for biochemical and microbiological studies, the production of control materials and the assembly of equipment.
BioMedical Production has expanded the number of residents of the Dubna special economic zone; today the biomedical cluster of the SEZ includes 39 companies.
Other
More than 70% of medical institutions face difficulties in maintaining medical equipment
Okdesk surveyed representatives of medical institutions from 40 regions from May 29 to July 3, 2023.
Among the surveyed medical institutions, the majority (68.2%) have an agreement with a third-party organization to maintain equipment, 27% have both their own service department and an agreement with a service company, 4.8% manage only with their own resources.
After the introduction of sanctions, it was necessary to reconfigure supply chains, which increased the delivery time for equipment and consumables. More than 75% of respondents reported difficulties in obtaining equipment and spare parts.
At the same time, the majority (54.1%) said that the difficulties were not critical, and 21.6% experienced major problems.
The CRPT summed up the results of the pilot on the labeling of medical devices
The experiment on labeling medical devices has been completed. As reported by the press service of the Center for the Development of Advanced Technologies (CRPT), 249 companies took part in it. These include 89 manufacturers, 54 importers, 71 healthcare institutions and more than 150 wholesale and retail companies. During the pilot project, more than 60 thousand labeling codes were applied and about 6.5 thousand product cards were described.
Labeling of medical products will help free the market from counterfeit goods and provide the population with legal goods, noted the CRPT. Over the past few years, according to the Ministry of Health, more than 250 criminal cases have been initiated in Russia based on the detection of falsified medical products.
The pilot on labeling medical devices took place from February 15, 2022 to August 31, 2023. The start of registration in the labeling system began on September 1, the implementation of labeling of medical devices will take place in stages. From October 1, 2023, labeling codes will be applied to wheelchairs, orthopedic products and air disinfectants, and from March 1, 2024 - to other medical products specified in the government decree: hearing aids, coronary stents, computed tomographs and sanitary products.
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