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The Medical Device Control Office will organize a series of seminars to enhance the public and healthcare professionals on their knowledge of medical devices. The third seminar in 2008 is now open for enrolment with details as follows:
| Topic |
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Regulation of Medical Devices in U.S. |
| Target Audience |
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Healthcare professionals, executives, engineers and regulatory staff in the medical device industry and other interested parties |
| Speakers |
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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
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| Content |
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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 |
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Lecture Hall, Hong Kong Science Museum, 2 Science Museum Road, Tsim Sha Tsui East, Kowloon, Hong Kong. |
| Time |
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| 1st Session: |
16 September 2008 (09:30 - 12:30) conducted in English |
| 2nd Session: |
16 September 2008 (14:00 - 17:00) conducted in English |
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Registration is free. Seats will be allocated on a first-come-first-served basis. For the details of seminar, please read the seminar poster.
If you are interested, please fax us the completed registration form for making reservation. |
| Important notices
