During the 17th GHWP Meeting in Chinese Taipei, it has been agreed the adaption of "Medical Device Adverse Event (AE) Report Form".

Please refer to the below attached with more information. 

Thank you. 

(WG2 is referred to WG4 after the restructuring of work groups.)

During the 17th GHWP Meeting in Chinese Taipei, it has been agreed the adaption of "Definition and Classification of Field Corrective Actions, including Field Safety Corrective Actions, Recalls and Non Safety related Field Corrective Actions".

Please refer to the below attached with more information. 

Thank you.

During the 17th GHWP Meeting in Chinese Taipei, it has been agreed the adaption of "Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers (Part 1-5)".

Please refer to the below attached with more information. 

Thank you.

(WG4 is referred to WG6 after the restructuring of work groups.)

Dear all participants,

Please kindly find the final agenda for your information.

Thank you very much.