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HKAPI Regulatory Training Workshop Series – Seminar 5 Medical Devices & Private Healthcare Facilities Ordinance
March 25, 2022 @ 2:00 pm - 4:30 pm
Medical Devices & Private Healthcare Facilities Ordinance Medical Device
Date: 25 March 2022 (Fri)
Time: 2:00 pm – 4:30 pm
Fee: To be confirmed
RSVP: Please contact the HKAPI Office
| Time | Topic | Speaker |
| 2:00 pm – 2:45 pm | Regulatory Framework of Medical Devices:
· Pre-market and post-market control · Requirement of listing · How will Medical Device Division process listing application of Drug – Device Combination Product & Companion Diagnostic IVDMD |
Mr. Yorkie Chow
Senior Electronics Engineer (Medical Device) 1 Medical Device Division Department of Health Mr. Alex Choi Senior Electronics Engineer (Medical Device) 2 Medical Device Division Department of Health |
| 2:45 pm – 3:30 pm | Private Healthcare Facilities Ordinance (PHFO):
Scope of the regulations and its applications |
Dr. Mark Lee
Medical & Health Officer – Advisory Committee Office for Regulation of Private Healthcare Facilities Department of Health |
| 3:30 pm – 4:00 pm | Implications of PHFO to Healthcare Professional & Drug and Medical Device Industry | Ms. Marcia Lee
Special Counsel Baker McKenzie |
| 4:00 pm – 4:30 pm | Panel Discussion | Ms Linda Chan (Moderator)
Regulatory Affairs Lead at Bristol Myers Squibb / Sub-team Lead of HKAPI Regulatory Affairs |
