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Draft Guidance Document and Application Form for Comments

Following the successful conduction of the two briefing sessions on the draft Guidance Notes for the Listing of Class B/C/D In Vitro Diagnostic (IVD) Medical Devices. Briefing materialsDOC are now available for download.

Remark: Please send us your comments by fax (852) 3157 1286 or by email mdco@dh.gov.hk on or before 31 Dec 2018.


Briefing sessions on Guidance Notes for Listing Class B, C and D In Vitro Diagnostic Medical Device

Our Office is planning to extend the listing scope of In Vitro Diagnostic Medical Device to cover Class B and C. Two briefing sessions with the same content but in different languages will be held. Details of the briefings are as follows:

Briefing Session No.1 (conducted in Cantonese) :
Date : 4 Dec 2018
Time : 2:30 p.m. to 3:30 p.m.
Venue: Lecture Theatre, Public Health Laboratory Centre, 382 Nam Cheong Street, Kowloon

Briefing Session No.2 (conducted in English) :
Date : 4 Dec 2018
Time : 4:00 p.m. to 5:00 p.m.
Venue: Lecture Theatre, Public Health Laboratory Centre, 382 Nam Cheong Street, Kowloon

Enrolment is free. To enroll, please download and complete the enrolment formDOC and fax the completed form to the Medical Device Control Office at (852) 3157 1286 on or before 26 Nov 2018.

The Guidance Notes is now posted for comments.

Please send us your comment by fax (852) 3157 1286 or by email mdco@dh.gov.hk on or before 31 Dec 2018.

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Last Revision Date : 13 November 2018