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HKAPI Regulatory Training Workshop Series – Seminar 5 Medical Devices & Private Healthcare Facilities Ordinance

三月 25, 2022 @ 2:00 下午 - 4:30 下午

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

衞生署

Mr. Alex Choi

Senior Electronics Engineer (Medical Device) 2

Medical Device Division

衞生署

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

衞生署

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

 

Details

Date:
三月 25, 2022
Time:
2:00 下午 - 4:30 下午
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