For endorsement at the 20th AHWP Meeting in Bangkok - PROPOSED FINAL documents


                                          
 

After consolidating the comments received from AHWP members by 30 Oct 2015, the PROPOSED documents developed by AHWP WGs has become PROPOSED FINAL documents as attached below, for endorsement at 20th AHWP Meeting in Bangkok.
 

 Download file:AHWP-WG1_CSDT Guidance_PROPOSED FINAL_r1.pdf 
 Download file:AHWP-WG1_Regulation of Combination Products - a Review of International Practice_PROPOSED FINAL.pdf 
 Download file:AHWP-WG2_WG1_MD IVD definition_PROPOSED FINAL_r1.pdf 
 Download file:AHWP-WG3_Guidance document on Medical Device Software_PROPOSED FINAL.pdf 
 Download file:AHWP-WG4_AE Reporting- PROPOSED FINAL.pdf 
 Download file:AHWP-WG5_Clinical Evaluation_PROPOSED FINAL.pdf 
 Download file:AHWP-WG5_Clinical Evidence for Medical Devices– Key Definitions and Concepts_PROPOSED FINAL.pdf 
 Download file:AHWP-WG5_Clinical Evidence for IVD medical devices – Key Definitions and Concepts_PROPOSED FINAL.pdf 
 Download file:AHWP-WG5_Clinical Evidence for IVD medical devices – Scientific Validity Determination_PROPOSED FINAL.pdf 
 Download file:AHWP-WG6_Auditing Checklist_PROPOSED FINAL_r1.pdf 
 Download file:AHWP_WG6_- Guidance on Regulatory Auditing of QMS of MD Distributors - Auditing Strategy_PROPOSED FINAL_r1.pdf 
 Download file:AHWP-WG6_Regulatory Audit Report Guidance Document_PROPOSED FINAL_r1.pdf 
 Download file:AHWP-STG_Guidance for Medical Device Naming Rule_PROPOSED FINAL_r1.pdf 

 

 

 Thank you for your notice.