Follow us on




Q of the week

Q: How Do You Get Shingles?

Get the Answer: 

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.

 Forums
Welcome Guest   [Register]  [Login]
EFGCP–EUCROF Joint Workshop Final Report   by  on 2010-08-20 20:12:20
Managing Clinical Trials   by  on 2010-07-16 00:05:32
US-FDA issues Revised Info Sheet Guidance on Clinical Investigator Disqualification   by  on 2010-06-13 18:11:41
US-FDA issues final guidance on Statement of Investigator (Form FDA 1572)   by  on 2010-06-13 18:07:59
Rising Clinical Trial Complexity Continues to Vex Drug Developers   by  on 2010-06-03 17:36:33
Investigator-Driven Clinical Trials: An ESF Forward Look   by  on 2010-06-03 17:27:58
NIH's Financial Conflict of Interest (FCOI) Proposed Rule   by  on 2010-05-27 19:42:00
AAP’s Guidelines for the Ethical Conduct of Studies to Evaluate Drugs in Pediatric Population   by  on 2010-05-13 19:39:54
Argentina: ANMAT - new regulatory update   by  on 2010-05-01 09:40:32
The Wall Street Journal's special supplement on clinical trials   by  on 2010-05-01 09:31:52
Major developments in EU Clinical Trial Guidances   by  on 2010-04-21 03:10:55
Analysis of the adverse reactions induced by natural product-derived drugs   by  on 2010-04-19 07:16:06
Newer Antibacterial Drugs for a New Century   by  on 2010-04-19 06:49:47
Newer Non-Statin Drugs for Reducing Cholesterol   by  on 2010-04-13 15:57:20
Practice Guidelines for Chronic Pain Management   by  on 2010-04-05 04:52:16
CONSORT III (2010)   by  on 2010-03-29 20:53:28
US FDA Draft Guidance on Pharmacokinetics in Patients with Impaired Renal Function   by  on 2010-03-20 20:25:16
US-FDA issues First Draft Guidance on Noninferiority Trials   by  on 2010-03-04 22:07:46
US FDA new rule on reporting information regarding falsification of data   by  on 2010-02-26 04:47:33
US-FDA Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials   by  on 2010-02-06 20:12:14
 Subject :Medical Device Control Office, DOH, Hong Kong invites public comments .. 2009-11-21 16:00:42 
GCP HelpDesk
Moderator
Joined: 2009-06-18 15:31:58
Posts: 62
Location
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

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


Powered by ccBoard