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Patient management software (PMS) is referred to as software that is regulated as a medical device. [1] It is software that is used to acquire medical information from a medical device to be used in the treatment or diagnosis of a patient. It can also be software that is an adjunct to a medical device and directly contributes to the treatment ...
Title II is given the short title of "Medical Device User Fee Amendments" (MDUFA). It defines terms relating to fees for medical devices. "30-day notice" is defined as a notice of a supplement to an approved application that is limited to a request to make modifications to manufacturing procedures or methods affecting the safety and ...
The July 2002 amendment to the law changed the regulatory structure for pharmaceuticals and medical devices, in an effort to align laws more closely with those in the European Union, Australia, Canada, and the United States. The amendment shifted the focus of regulation from the point of manufacturing to the point of sale, and adopted a risk ...
On 25 March 2011 [5] and after the pH1N1 pandemic, [3] amendments were made to the Food and Drug Regulations (FDR) to include a specific regulatory pathway for EUNDs. Typically, clinical trials in human subjects are conducted and the results are provided as part of the clinical information package of a New Drug Submission (NDS) to Health Canada ...
Jurisdiction Definition Legislation Australia A medical device that: (a) is made specifically in accordance with a request by a health professional specifying the design characteristics or construction of the medical device; and (b) is intended: (i) to be used only in relation to a particular individual; or (ii) to be used by the health professional to meet special needs arising in the course ...
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.
ISO 13485. ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is a voluntary standard, [1] published by International Organization for Standardization (ISO) for the first time in 1996, and contains a comprehensive quality management system for the design and manufacture of medical devices.
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.