醫療儀器管制辦公室

活動

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醫療儀器講座 - 美國醫療儀器的規管

醫療儀器管制辦公室將舉辦一系列講座，旨在增強市民及醫護人員對醫療儀器的有關知識。在二零零八的第三個醫療儀器講座現已開始接受報名，詳情如下：

（只有英文版本）

Topic

Regulation of Medical Devices in U.S.

Target Audience

Healthcare professionals, executives, engineers and regulatory staff in the medical device industry and other interested parties

Speakers

Mr. John F. Stigi (Director)
Mr. William M. Sutton (Deputy Director)
Division of Small Manufacturers, International, & Consumer Assistance Office of Communication, Education, and Radiation Programs
Center for Devices and Radiological Health
U.S. Food and Drug Administration

Content

The seminar discusses
1st Session. U.S. FDA Organization and Mission, Definition of a Device, Classification of a Device, Premarket Notification [510(k)], Premarket Approval (PMA), & Electronic Registration and Listing.

2nd Session. Quality System Regulations (21 CFR Part 820), Medical Device Reporting (MDR), Medical Device Recalls, Postmarket Surveillance, & Medical Device Tracking.

Venue

Lecture Hall, Hong Kong Science Museum, 2 Science Museum Road, Tsim Sha Tsui East, Kowloon, Hong Kong.

Time