Regulatory Aspects: Pharmaceuticals, Medical Devices, Food Additives

2011 ◽  
pp. 565-572
Author(s):  
Abigail Jacobs ◽  
Jan-Willem van der Laan
Keyword(s):  
Medical Devices ◽  
Food Additives ◽  
Regulatory Aspects

Medical devices regulatory aspects: a special focus on polymeric material based devices

2015 ◽  
Vol 21 (42) ◽  
pp. 6246-6259 ◽  
Author(s):  
Radhakrishnan Sridhar ◽  
Damian Pliszka ◽  
He-Kuan Luo ◽  
Keith Chin Lim ◽  
Seeram Ramakrishna
Keyword(s):  
Polymeric Material ◽  
Medical Devices ◽  
Special Focus ◽  
Regulatory Aspects

scholarly journals Considerations on D-mannose Mechanism of Action and Consequent Classification of Marketed Healthcare Products

2021 ◽  
Vol 12 ◽  
Author(s):  
Francesco Scaglione ◽  
Umberto M. Musazzi ◽  
Paola Minghetti
Keyword(s):  
Medical Devices ◽  
Bacterial Adhesion ◽  
Antibiotics Resistance ◽  
Adult Women ◽  
Urothelial Cells ◽  
Regulatory Aspects ◽  
Alternative Approach ◽  
Tract Infections ◽  
Adhesive Effect

Urinary tract infections (UTIs) are very common disorders that affect adult women. Indeed, 50% of all women suffer from UTIs at least one time in their lifetime; 20–40% of them experience recurrent episodes. The majority of UTIs seems to be due to uropathogenicEscherichia colithat invades urothelial cells and forms quiescent bacterial reservoirs. Recurrences of UTIs are often treated with non-prescribed antibiotics by the patients, with increased issues connected to antibiotics resistance. D-mannose, a monosaccharide that is absorbed but not metabolized by the human body, has been proposed as an alternative approach for managing UTIs since it can inhibit the bacterial adhesion to the urothelium. This manuscript discusses the mechanisms through which D-mannose acts to highlight the regulatory aspects relevant for determining the administrative category of healthcare products placed on the market. The existing literature permits to conclude that the anti-adhesive effect of D-mannose cannot be considered as a pharmacological effect and, therefore, D-mannose-based products should be classified as medical devices composed of substances.

scholarly journals Regulatory aspects of medical devices in India

2017 ◽  
Vol 9 (2) ◽  
pp. 18
Author(s):  
Monika Targhotra ◽  
Geeta Aggarwal ◽  
Harvinder Popli ◽  
Madhu Gupta
Keyword(s):  
Public Health ◽  
Medical Device ◽  
Medical Devices ◽  
Large Population ◽  
Regulatory Body ◽  
Design Development ◽  
Market Place ◽  
Safety Assurance ◽  
Regulatory Aspects ◽  
Regulatory Guidelines

<p>Today millions of patients depend on medical device based treatment for the management and diagnose of several diseases. Quality and safety of device is depends upon the regulatory guidelines. Medical device manufacturing in India should be taken seriously due to large population and the potential severity of the consequences of introducing inferior and unsafe products to the market-place. Therefore a law containing adequate guidelines of rules and regulations are required for monitoring the entry of such devices into the use in public health. The regulations define requirements of medical device design, development and manufacture to ensure that products reaching market are safe and effective. Presently in India regulatory body CDSCO is governing regulation for regulation of devices which with time, amendment introducing in the law will provide safety assurance to public health. This review provides a study on different regulatory aspects of medical device implemented in India. The present review discuss about the classification of medical devices and regulations aspects in India.</p>

Global trends in circulation of medical devices

2019 ◽  
Vol 2019 (3) ◽  
pp. 21-23 ◽  
Author(s):  
Елена Астапенко ◽  
Elena Astapenko ◽  
Анна КОРТОШКИНА ◽  
Anna KORTOShKINA
Keyword(s):  
Medical Device ◽  
Russian Federation ◽  
Medical Devices ◽  
International Medical ◽  
Regulatory Environment ◽  
Global Trends ◽  
Regulatory Aspects ◽  
The Russian Federation

The article presents main tendencies in development of the legal and regulatory environment in circulation of medical devices in world’s major states. The article depicts major developed in regulatory aspects in countries members of the International Medical Device Regulators Forum (IMDRF) that took place in the late 2018 – early 2019, which are important for subjects of circulation of medical devices which planning their activities not only in the Russian Federation territory, but also abroad.

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