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Briefing Sessions: Proposed Documents related to Conformity Assessment under the Medical Device Administrative Control System
 

Below you will be able to download two proposed documents related to conformity assessment of medical devices. You are welcomed to send us your comments on the proposed documents by 31 August 2006, by post, e-mail or fax.

Post : Medical Device Control Office 18/F, Wu Chung House
213 Queen's Road East
Wanchai, Hong Kong
E-mail : mdco@dh.gov.hk
Fax : 3157 1286

Proposed Guidance Notes GN-04: Conformity Assessment Framework and Conformity Assessment Bodies [PDF ]

Proposed Technical Reference TR-001: Principles of Conformity Assessment for Medical Devices [PDF ]

Two briefing sessions of the same content, introducing the conformity assessment framework and the role of Conformity Assessment Bodies, have been arranged as follows ¡V

(I) Date : 10 August 2006 (conducted in Cantonese)
  Time : 10:00 a.m. - 12:00 noon
  Venue : Lecture Hall, Sheung Wan Civic Centre, 5/F Sheung Wan Municipal Services Building, 345 Queen's Road Central, Hong Kong (Exit A1 / A2 of Sheung Wan MTR Station)
       
(II) Date : 10 August 2006 (conducted in English)
  Time : 3:00 p.m. - 5:00 p.m.
  Venue : Lecture Hall, Sheung Wan Civic Centre, 5/F Sheung Wan Municipal Services Building, 345 Queen's Road Central, Hong Kong (Exit A1 / A2 of Sheung Wan MTR Station)

If you are interested, please fax the completed registration form to us (Fax. No.: 3157 1286) for reservation. Seats will be allocated on a first-come-first-served basis.

Registration Form for Briefing [PDF ]
Presentation slides for the Briefing [PDF ][NEW! ]


[Get Adobe Reader ] Adobe Reader is required for viewing and printing the Portable Document Format (PDF) documents. To download Adobe Reader, please click here.
 
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Last revision date: 23 August 2006