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    • Work Group 2 (WG2) - Pre-market: IVDD
    • Work Group 3 (WG3) - Pre-market: Software as a Medical Device
    • Work Group 4 (WG4) - Post-Market
    • Work Group 5 (WG5) - Clinical Evidence for Performance and Safety
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GHWP Procedure for Strategic Advisory Board Establishment and Operation

Submitted by admin on Fri, 07/07/2023 - 15:31

Kindly find the GHWP Procedure for Strategic Advisory Board Establishment and Operation below for your reference.

Please feel free to contact the Secretariat at secretariat@ghwp.info for any queries. Thank you.

  • Read more about GHWP Procedure for Strategic Advisory Board Establishment and Operation

The 4-step Process for Preparing AHWP Official Documents

Submitted by admin on Wed, 10/09/2013 - 16:32


Please find the PPT below for your reference.

Any comment, please feel free to contact Secretariat at secretariat@ahwp.info 

Thank you.

  • Read more about The 4-step Process for Preparing AHWP Official Documents

2010 New Year Greeting Message from Chairman Wang

Submitted by admin on Wed, 12/23/2009 - 16:41


2010 New Year Greeting Message from 
Chairman Wang
 


Dear friends and GHWP member economies,

2009 is running to its end, and we will soon embrace 2010 amid the New Year chimes. A brand-new year will bring us new hopes and new dreams.

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GHTF Proposed Document: Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED)

Submitted by admin on Sat, 11/25/2006 - 16:40


To download the document, please click the document link below. 

Attachment(s):

  • Read more about GHTF Proposed Document: Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED)

Canada: Guidance for Manufacturers Preparing A Pre-Market Application Using STED; Draft Guidance for Industry

Submitted by admin on Sat, 11/25/2006 - 16:38


To download the document, please click the document link below.

Attachment(s): 

  • Read more about Canada: Guidance for Manufacturers Preparing A Pre-Market Application Using STED; Draft Guidance for Industry

Notice of Election and Agenda

Submitted by admin on Fri, 11/24/2006 - 16:36


To download the files, use the links below. 

Attachment(s): 

  • Read more about Notice of Election and Agenda

Program of the 1st AHWP Technical Committee Meeting and Workshop

Submitted by admin on Fri, 11/24/2006 - 16:33


To download the files, use the links below. 

Attachment(s): 

  • Read more about Program of the 1st AHWP Technical Committee Meeting and Workshop

Technology Development

Submitted by admin on Fri, 11/24/2006 - 16:23

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US FDA: A Pilot Program to Evaluate a Proposed Globally Harmonized Alternative for Premarket Procedures; Guidance for Industry and FDA Staff

Submitted by admin on Wed, 11/15/2006 - 16:30


To download the document, please click the document link below.

Attachment(s): 

  • Read more about US FDA: A Pilot Program to Evaluate a Proposed Globally Harmonized Alternative for Premarket Procedures; Guidance for Industry and FDA Staff
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