{"id":11705,"global_id":"www.hkapi.hk\/zh\/?id=11705","global_id_lineage":["www.hkapi.hk\/zh\/?id=11705"],"author":"68","status":"publish","date":"2022-02-08 16:24:30","date_utc":"2022-02-08 08:24:30","modified":"2022-03-21 09:58:49","modified_utc":"2022-03-21 01:58:49","url":"https:\/\/www.hkapi.hk\/zh\/event\/hkapi-regulatory-training-workshop-series-seminar-5\/","rest_url":"https:\/\/www.hkapi.hk\/zh\/wp-json\/tribe\/events\/v1\/events\/11705","title":"HKAPI Regulatory Training Workshop Series – Seminar 5 Medical Devices & Private Healthcare Facilities Ordinance","description":"

Medical Devices & Private Healthcare Facilities Ordinance Medical Device<\/span><\/h2>\n

Date: 25 March 2022 (Fri)<\/abbr><\/p>\n

Time: 2:00 pm – 4:30 pm<\/p>\n

Fee: To be confirmed<\/p>\n

RSVP: Please contact the HKAPI Office<\/p>\n\n\n\n\n\n\n\n
Time<\/strong><\/td>\nTopic<\/strong><\/td>\nSpeaker<\/strong><\/td>\n<\/tr>\n
2:00 pm – 2:45 pm<\/td>\nRegulatory Framework of Medical Devices:<\/p>\n

\u00b7\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Pre-market and post-market control<\/p>\n

\u00b7\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Requirement of listing<\/p>\n

\u00b7\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 How will Medical Device Division process listing application of Drug \u2013 Device Combination Product & Companion Diagnostic IVDMD<\/td>\n

Mr. Yorkie Chow<\/strong><\/p>\n

Senior Electronics Engineer (Medical Device) 1<\/p>\n

Medical Device Division<\/p>\n

Department of Health<\/p>\n

Mr. Alex Choi<\/strong><\/p>\n

Senior Electronics Engineer (Medical Device) 2<\/p>\n

Medical Device Division<\/p>\n

Department of Health<\/td>\n<\/tr>\n

2:45 pm – 3:30 pm<\/td>\nPrivate Healthcare Facilities Ordinance (PHFO):<\/p>\n

Scope of the regulations and its applications<\/td>\n

Dr. Mark Lee<\/strong><\/p>\n

Medical & Health Officer \u2013 Advisory Committee<\/p>\n

Office for Regulation of Private Healthcare Facilities<\/p>\n

Department of Health<\/td>\n<\/tr>\n

3:30 pm – 4:00 pm<\/td>\nImplications of PHFO to Healthcare Professional & Drug and Medical Device Industry<\/td>\nMs. Marcia Lee<\/strong><\/p>\n

Special Counsel<\/p>\n

Baker McKenzie<\/td>\n<\/tr>\n

4:00 pm – 4:30 pm<\/td>\nPanel Discussion<\/td>\nMs Linda Chan (Moderator)<\/strong><\/p>\n

Regulatory Affairs Lead at Bristol Myers Squibb \/ Sub-team Lead of HKAPI Regulatory Affairs<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

 <\/p>\n

\"\"<\/a><\/p>","excerpt":"

Seminar 5 – Medical Devices & Private Healthcare Facilities Ordinance
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