Privacy Impact Assessment - Medical Device Problem Reporting (August 2013)
Description of Program or Activity
The Program monitors and evaluates the safety, efficacy and quality of diagnostic and therapeutic medical devices in Canada so that Consumers and Health Care Professionals can use them with confidence. The Medical Device System (MDS) database is Canada's official repository for the medical device problem reports and operates in the Therapeutic Products Directorate (TPD), Medical Devices Bureau (MDB) within the Health Products and Food Branch (HPFB) of HC. Within the HPFB, three Directorates are involved in the Medical Device Problem Reporting Program: Marketed Health Products Directorate (MHPD), Health Products and Food Branch Inspectorate (HPFBI) and Therapeutic Products Directorate (TPD). All three groups have access to the MDS and specific user 'rights' depending on their responsibilities. The Program is currently managed under a matrix structure within HPFB, where decision-making authority is shared among the Directorates for staff and funds.
Legal Authority for Program or Activity
Legal authority for the collection of personal information in the Medical Device Problem Reporting Program is pursuant to the Department of Health Act, Section 4, and the Food and Drugs Act, Section23 (1) (c) and associated Medical Devices Regulations, Section(s) 59 (1) (a) (b) (2), 60, 61.1 (1), 63, 64 and 65, 77, 81 (k) (v) (2) and 88.
Related Personal Information Bank
The collection and use of personal information with the Medical Device Problem Reporting Program is described in the Personal Information Bank (PIB) - Medical Device Problem Reporting Program - PIB, HC PPU 415.
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