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Submitted by admin on Mon, 11/02/2015 - 18:58


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

Thank you for your notice.

Download file
AHWP-STG_Guidance for Medical Device Naming Rule_PROPOSED FINAL_r1.pdf
AHWP_WG6_- Guidance on Regulatory Auditing of QMS of MD Distributors - Auditing Strategy_PROPOSED FINAL_r1.pdf
AHWP-WG6_Regulatory Audit Report Guidance Document_PROPOSED FINAL_r1.pdf
AHWP-WG6_Auditing Checklist_PROPOSED FINAL_r1.pdf
AHWP-WG5_004_PROPOSED FINAL.pdf
AHWP-WG5_003_PROPOSED FINAL.pdf
AHWP-WG4_AE Reporting- PROPOSED FINAL.pdf
AHWP-WG5_Clinical Evaluation_PROPOSED FINAL.pdf
AHWP-WG3_Guidance document on Medical Device Software_PROPOSED FINAL.pdf
AHWP-WG5_002_PROPOSED FINAL.pdf
AHWP-WG2 WG1_MD IVD definition_PROPOSED FINAL_r1.pdf
AHWP-WG1_Regulation of Combination Products - a Review of International Practice_PROPOSED FINAL.pdf
AHWP-WG1_CSDT Guidance_PROPOSED FINAL_r1.pdf

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