In recent years, manufacturers, distributors and users of medical devices have increasingly faced the results of state control over the treatment of MD.
The occurrence of collisions occurs due to gaps in knowledge of the laws governing the circulation of a medical device.
During the implementation of state control over the circulation of medical devices by the Federal Service for Healthcare, typical violations characteristic of various subjects of circulation of medical devices are revealed:
- Manufacturers of medical devices:
- production of substandard products;
- sale of unregistered medical devices, including medical devices with characteristics and materials other than those specified in the set of registration documentation;
- violation of labeling;
- changing the location and place of production without notifying Roszdravnadzor and making appropriate changes to the registration certificate.
- Medical Device Suppliers:
- violation of labeling (absence of names and instructions in Russian, etc.);
- sale of unregistered medical devices (without registration certificate, invalid registration certificate, etc.);
- dissemination of false information about Roszdravnadzor's decisions, unauthorized interpretation of Roszdravnadzor's decisions, failure to inform the territorial bodies of Roszdravnadzor about the identification of medical devices in circulation that do not meet the established requirements.
- Pharmacy organizations:
- violation of the storage conditions of medical devices;
- sale of unregistered medical devices (without registration certificate, invalid registration certificate, etc.);
- Medical organizations:
- usage of unregistered medical devices (without registration certificate, invalid registration certificate, etc.);
- untimely maintenance of medical devices (CT, MRI, X-ray, etc.);
- storage and use of expired medical devices;
- failure to inform the territorial bodies of Roszdravnadzor about the detection of medical devices in circulation that do not meet the established requirements.
Here are the main reasons why the above violations occur:
- untimely changes to the registration documentation due to changes in the characteristics of the medical device (composition of accessories, labeling, design, materials of manufacture, software version, etc.);
- untimely introduction of changes due to changes in the operational documentation (instructions, manuals) for a medical device;
- need to updating the standards (domestic and foreign) that the medical device meets;
- modification/adjustment of the purpose, scope of application of the medical device, storage and operating conditions;
- lack of post-registration clinical monitoring of the treatment of a medical device;
- the absence or untimely updating of information on the maintenance of a medical device, its transportation and disposal.
In accordance with Federal Law No. 323-FZ dated 11/21/2011 "On the basics of public health protection", the sale of counterfeit, substandard and counterfeit medical products is prohibited.
Administrative liability is provided for violations in the field of circulation of medical devices, in accordance with Articles 6.28 and 6.33 of the "Code of Administrative Offences of the Russian Federation", and criminal liability is established for the circulation of falsified, substandard and unregistered medical devices in accordance with Article 238.1 of the Criminal Code of the Russian Federation.
How to act in such situations:
- assessment of discrepancies in the information in the current documentation by US and the registration dossier located in the Roszdravnazor;
- analysis of changes in the current standards, which each specific MD must comply with;
- checking for the presence of identified cases of adverse events during the use of MD;
- planning and implementation of priority actions to eliminate identified inconsistencies/violations.