Medical Devices. Post Market Surveillance: Global Guidance for Adverse Event Reporting for Medical Devices — GHTF/SG2/N54R8: 2006, Study Group 2 Final Document’’, typical adverse events for medical devices include but are not limited to: · a malfunction or deterioration in the characteristics or performance · an incorrect or out of specification test result · an inaccuracy in the labeling, instructions for use and/or promotional materials. Inaccuracies include omissions and deficiencies. Omissions do not include the absence of information that should generally be known by the intended users. · use error All AEs (serious and non-serious) shall be reported as specified in this section of the Protocol and the expanded Medical Device Reporting Guidelines, which will be provided to all investigators prior to the start of the study.
Medical Devices has the meaning given to it in the Medical Devices Regulations under the Food and Drugs Act (Canada).
Medical Devices means Company’s Modular Knee implant device described in Exhibit C, but expressly excluding the [***] Project described in Exhibit C.
Examples of Medical Devices in a sentence
In addition, Medical Devices must be configured so that only Supplier-approved applications will run on such Medical Devices.
Supplier warrants that any Good or Medical Device is compliant with FDA’s most current guidance or regulation for the quality system related to the cybersecurity and the Management of Cybersecurity in Medical Devices, and that Supplier will maintain compliance with any updates to such guidance or regulations.
In addition, Medical Devices must be configured so that only Supplier-approved applications will run.
CareFirst BlueChoice provides benefits for Medical Devices and Supplies obtained through designated Contracting Providers.
If any of the Products are medical devices, Buyer acknowledges that it is familiar with the U.S. Safe Medical Devices Act of 1990 (the “Devices Act”) and the reporting obligations imposed on device users thereunder.
More Definitions of Medical Devices
Medical Devices means products, including instruments, apparatus, in vitro diagnostics, software and other goods or substances which are intended to have or are presented as having a medical use and whose principal effect is not obtained with a medicinal product;
Medical Devices means any instruments, vessels, devices, equipment, materials, and other manufactured articles used for medicinal purposes either individual or in combination with one another, along with appliances required for using said devices for the designated purpose (including any purpose-built software), which are intended by their manufacturers to be used for prevention, diagnostics, or treatment of diseases, medical rehabilitation and monitoring of the human organism, conducting medical studies, restoring, substituting, or modifying the anatomical structure or physiological functions of the organism, preventing or terminating a pregnancy, and whose functional purpose is carried out other than through pharmacological, immunological, genetic, or metabolic effect on the human organism, but may be supported by medicinal products;
Medical Devices means instruments, equipment, appliances, materials or other items that are used, alone or in combination, on the human body which are registered (注册) or filed (备案), from time to time, with the local departments of the China Food and Drug Administration as a “medical device” (“医疗器械”) in accordance with the Regulations for the Supervision and Administration of Medical Devices (“《医疗器械监督管理条例》”) (as such laws and regulations may be amended from time to time), and being instruments, equipment, appliances, materials or other items which are primarily sold under the primary categories “OTC Drug / Medical Devices / Family Planning Products” ( “OTC 药品/医疗器械/计生用品” ) and “Contact Lenses / Contact Lens Solution” (“隐形眼镜/护理液”) under the Tmall business category “Healthcare Products and Medicine” (“保健品及医药”) on Xxxxx.xxx;
Medical Devices means therapeutic products consisting of an instrument, apparatus, appliance, material or other article (whether for use alone or in combination), together with any accessories or software required for its proper functioning, which does not achieve its principal intended action by pharmacological, chemical, immunological or metabolic means, though it may be assisted in such function by such means;
Medical Devices as opposed to “drugs”. This means substantially shorter and less expensive path to the regulatory approval. For instance, the company began developing its absorbent localized hemostatic agent (TDM-621) in Japan around 2009 and if it brings TDM-621 to the market during FY04/13 as planned, it will mean it took 3-4 years from scratch to launch. Furthermore, 3DM claims it can keep development costs down by actively using outside parties. Also, all 3DM pipeline products use basically the same raw material (the RADA 16 self-assembling peptides). Therefore, once it successfully completes clinical trials
Medical Devices means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar article that is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease and that are regulated by the FDA.
Medical Devices shall have the meaning given in Section 201(h) of the FDCA.