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Marketing authorisation is the process of reviewing and assessing the evidence to support a medicinal product, such as a drug, in relation to its marketing, finalised by granting of a licence to be sold. This process is performed within a legal framework defining the requirements necessary for successful application to the regulatory authority ...
The certificate of pharmaceutical product (abbreviated: CPP) is a certificate issued in the format recommended by the World Health Organization (WHO), which establishes the status of the pharmaceutical product and of the applicant for this certificate in the exporting country; [1] it is often mentioned in conjunction with the electronic Common Technical Document (eCTD).
Health Canada (HC; French: Santé Canada, SC) [NB 1] is the department of the Government of Canada responsible for national health policy. The department itself is also responsible for numerous federal health-related agencies, including the Canadian Food Inspection Agency (CFIA) and the Public Health Agency of Canada (PHAC), among others.
Patient management software is classified as either Class I or Class II. Software that is intended to be used to view images, or other real-time data, as an adjunct to the monitoring device itself, for the purpose of aiding in the treatment or diagnosis of a patient, would be Class I medical devices. Medical device software that is an adjunct ...
Category:Regulation of medical devices. Category. : Regulation of medical devices. Medical Devices regulations cover all the topics related to the laws, standards or submissions process, with which compliance is required by manifold national and international bodies to commercialize a medical device.
Healthcare in Canada is delivered through the provincial and territorial systems of publicly funded health care, informally called Medicare. [1][2] It is guided by the provisions of the Canada Health Act of 1984, [3] and is universal. [4]: 81 The 2002 Royal Commission, known as the Romanow Report, revealed that Canadians consider universal ...
Electronic prescription (e-prescribing or e-Rx) is the computer-based electronic generation, transmission, and filling of a medical prescription, taking the place of paper and faxed prescriptions. E-prescribing allows a physician, physician assistant, pharmacist, or nurse practitioner to use digital prescription software to electronically ...
The Global Harmonization Task Force (GHTF) was “a voluntary group of representatives from national medical device regulatory authorities (such as the U.S. Food and Drug Administration (FDA)) and the members of the medical device industry ” [1] whose goal was the standardization of medical device regulation across the world.