The Launching of Medical Devices - the Conformity Assessment and Registration Process in the Czech Republic

Author(s):  
Hana Mohelská ◽  
Blanka Klímová ◽  
Petra Marešová ◽  
Ladislav Hájek ◽  
Michal Novotný ◽  
...  
2016 ◽  
Vol Volume 12 ◽  
pp. 1593-1597 ◽  
Author(s):  
Petra Marešová ◽  
Matus Peteja ◽  
Milan Lerch ◽  
Pavel Zonca ◽  
Kamil Kuca

2015 ◽  
Vol 36 (4) ◽  
pp. 603-638 ◽  
Author(s):  
Peter Bolcha ◽  
Jan Rovný

AbstractResearch into the detection of fraud and corruption has brought many new insights in recent decades, partly thanks to a decrease in the costs of data collection and processing. However, access to data often remains an issue, especially when fraud or corruption seems to be present. This article applies a simple detection method focussing on possible manipulations in the car registration process in the Czech Republic, where car registration plates are allegedly assigned in random order. As access to official data was denied, we collected data in the field for a random sample of 5,000 cars, and used this to examine the existence of statistical relationships between the cars’ estimated price at registration and their registration plate numbers. The results show that cars with intuitively appealing registration plates are on average significantly more expensive than other cars. Moreover, this price difference corresponds to the relative scarcity of the given type of registration plate number, which could be a sign of discretionary behaviour in the allocation of such plates.


2021 ◽  
Vol 9 ◽  
Author(s):  
Petra Maresova ◽  
Lukas Rezny ◽  
Lukas Peter ◽  
Ladislav Hajek ◽  
Frank Lefley

Background: Within the EU, some of the challenges and perceived risks now facing medical device (MD) developers result from changes in the regulatory framework, emphasizing safety. Therefore, medical technology companies must adopt stricter quality assurance measures so that individual devices can be speedily tracked and retrieved in emergency situations.Objectives: We highlight the challenges and risks faced by the European medical devices industry, particularly those faced by SMEs in the Czech Republic. We address two important research questions: Q1. Do advantages from increased regulation outweigh the additional expenses? Q2. As many MD developers are SMEs, will the new regulatory regime result in some of those companies going out of business and therefore impede future innovation?Methods: The paper focuses on a single case study, with the situation and outcomes discussed in the context of the financial results of a further 50 medical device manufacturers marketing in the Czech Republic.Results: Our findings suggest that the new legislation will result in improved safety, facilitate product recalls, but the cost and administrative burden may be high. The evidence also indicates that some SMEs may be forced to diversify to “non-medical” products, with the inevitable loss of innovative MDs being made available to patients and healthcare providers.


2021 ◽  
Vol 14 (2) ◽  
pp. 253-272
Author(s):  
Jana Rozmarinová ◽  
Barbora Říhová

Abstract Health technology assessment (HTA) has become the systematic evaluation of health technology’s properties and effects that inform decision-makers. The implementation and expansion of HTA can contribute to slowing down burgeoning healthcare costs. In the Czech Republic, elements of HTA are quite standardly used in pharmacoeconomics, but questions arise on the use of HTA of medical devices. The theoretical framework developed is followed by a case study of the Czech Republic to assess whether the use of HTA of medical devices in the Czech Republic is implemented. This study uses publicly available resources, mainly public health acts and public notices related to HTA. We examined the institutionalisation of HTA for medical devices (HTA applied only at a selected area of medical devices) in the Czech Republic and compared Czech’s HTA principles of medical devices to the HTA Core Model. It was found that the HTA process used for medical devices is very limited in the Czech Republic. Our data show that HTA was officially established, but in reality, the medical devices have not been assessed following HTA principles.


2011 ◽  
Vol 38 (No. 1) ◽  
pp. 21-26 ◽  
Author(s):  
T. Zichová ◽  
V. Falta ◽  
F. Kocourek ◽  
J. Stará

The Cydia pomonella granulovirus is a very important agent for the biological control of the codling moth, Cydia pomonella, in both organic and integrated apple and pear production. Three populations of Cydia pomonella originating from three separate areas of the Czech Republic were tested for their susceptibility to Cydia pomonella granulovirus in laboratory bioassays at several concentrations of Cydia pomonella granulovirus. A sensitive laboratory strain was chosen as a control. The larval mortality was checked 14 days after the infection. The mortality of Cydia pomonella larvae was similar in specimens originating from both the wild populations and the laboratory strain. Decreased susceptibility to Cydia pomonella granulovirus was demonstrated neither in samples from locality without Cydia pomonella granulovirus treatment nor from a locality experimentally treated with Cydia pomonella granulovirus for several years during the registration process. However, one population experimentally treated for more than 10 years was partially resistant to Cydia pomonella granulovirus. Based on our findings; the Cydia pomonella granulovirus biopesticides will be efficient due to the high susceptibility of field codling moth populations to Cydia pomonella granulovirus in the Czech Republic.


2020 ◽  
Vol 66 (6) ◽  
pp. 372-381
Author(s):  
Lenka Straková ◽  
Vladimír Nesvadba ◽  
Jindřich Křivánek ◽  
Martin Slabý ◽  
Tomáš Vrzal ◽  
...  

In the Czech Republic breeding of new hop varieties is traditionally performed. Its properties correspond with the requirements and interests of end users, in particular hop growers, brewers and especially beer consumers, who with an increasing favor taste new types of beer. The study presents 8 new promising aromatic genotypes, whose major part (Uran, Juno, Ceres, Jupiter, Eris and Most) is already in the registration process of ÚKZÚZ of the Czech Republic (Central Institute for Supervising and Testing in Agriculture CISTA). The tested genotypes were described using brewing tests. Regarding the character of the tested hop varieties, there was chosen a uniform and simple infusion recipe with a top fermentation and dry hopping. The final beer samples were evaluated using chemical and sensorial analyses focusing on a hop aroma. All beer samples were rated as very good, the overall impression of the samples on the scale of 1 to 9 ranged from 2.9 to 3.1. The hop aroma and also bitterness character of the final beer samples were evaluated of high quality. Depending on the hop profile of the beer samples, there were suggested beer styles where the given varieties can be successfully used. These results indicate a high potential of these varieties for the use in brewing practice. Finally, the probability of perceiving a particular hop aroma in beer given by perceiving the aroma in hops was determined by Bayes’ theorem. It was found that probability particularly for spicy, resinous, herbal, citrusy, floral, fruity and grassy aroma was 100, 100, 100, 40, 38, 43, and 100%, respectively.


1998 ◽  
Vol 12 (1) ◽  
pp. 7-24 ◽  
Author(s):  
Koupilova ◽  
Vagero ◽  
Leon ◽  
Pikhart ◽  
Prikazsky ◽  
...  

GeroPsych ◽  
2012 ◽  
Vol 25 (3) ◽  
pp. 161-166
Author(s):  
Hana Stepankova ◽  
Eva Jarolimova ◽  
Eva Dragomirecka ◽  
Irena Sobotkova ◽  
Lenka Sulova ◽  
...  

This work provides an overview of psychology of aging and old age in the Czech Republic. Historical roots as well as recent activities are listed including clinical practice, cognitive rehabilitation, research, and the teaching of geropsychology.


Sign in / Sign up

Export Citation Format

Share Document