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Prototype devices

It is recognized that a manufacturer may wish to submit a small number  of "prototype models" of a device to clinical investigation in order to assess safety and/or performance; and those such prototypes may need to undergo a number of changes prior to large-scale production.
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 Subject :Medical Device Control Office, DOH, Hong Kong invites public comments .. 2009-11-21 16:00:42 
GCP HelpDesk
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Subject :Medical Device Control Office, DOH, Hong Kong invites public comments on guidance

A public consultation exercise for the proposed Guidance Notes for Applicants of the Certificate for Clinical Trial on Medical Device is launched on 1 November 2009. Draft Guidance Notes in bilingual are now available on website for download. The closing date for comments about the proposed documents has been set on 31 January 2010. Please return comments to the address given here on or before 31 January 2010. You may give your comments addressed to Dr Jackie LEUNG via the following means : 1) by email : pro1_mdco@dh.gov.hk , 2) by fax : 3157 1286, and 3) by post : Room 3101, 31/F, Hopewell Centre, 183 Queen ' s Road East, Wanchai

Medical Device Control Office
Department of Health
Hong Kong SAR Government

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Last Edited On: 2009-11-21 16:00:42 By GCP HelpDesk for the Reason
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