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For endorsement at the 18th AHWP Meeting in Malaysia - PROPOSED FINAL documents on " Asian Harmonization Working Party Strategic Framework (2012~2014) - “The Foreseeable Harmonization Horizon””

After consolidating the comments received from GHWP members by 26 Nov 2013, the PROPOSED document on " Global Harmonization Working Party Strategic Framework (2012~2014) - “The Foreseeable Harmonization Horizon”” developed by GHWP Office Bearers has become the captioned PROPOSED FINAL document, for endorsement at 18th GHWP Meeting in Malaysia.

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For endorsement at the 18th AHWP Meeting in Malaysia - PROPOSED FINAL documents on "Quality management system – Medical devices – Nonconformity Grading System for Regulatory Purposes and Information Ex-change”

After consolidating the comments received from GHWP members by 26 Nov 2013, the PROPOSED document on "Quality management system – Medical devices – Nonconformity Grading System for Regulatory Purposes and Information Ex-change" developed by GHWP WG3 has become the captioned PROPOSED FINAL document, for endorsement at 18th GHWP Meeting in Malaysia.

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For endorsement at the 18th AHWP Meeting in Malaysia - PROPOSED FINAL documents on "Adverse Event Reporting Guidance for the Medical Device Manufacturer or its Authorized Representative”

After consolidating the comments received from GHWP members by 26 Nov 2013, the PROPOSED document on "Adverse Event Reporting Guidance for the Medical Device Manufacturer or its Authorized Representative" developed by GHWP WG2 has become the captioned PROPOSED FINAL document, for endorsement at 18th GHWP Meeting in Malaysia. Thank you for your notice.

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Notice - Training/Meeting for AHWP WG3, WG4 and WG5 (2 Dec 2013)

Dear GHWP WG3/4/5 members,

Please note that the training/ meeting for GHWP WG3/4/5 will be held on 2 Dec at 4-5/5-6/6-7pm respectively, embedded in the 18th GHWP Meeting and 1st GHWP-RAPS Joint Conference with the details below:

Date: 2 Dec 2013 (Mon)

Time: 4-5/5-6/6-7pm

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For endorsement at the 18th AHWP Meeting in Malaysia - PROPOSED FINAL documents on "Essential Principles of Safety and Performance of IVD Medical Devices”

Read more about For endorsement at the 18th AHWP Meeting in Malaysia - PROPOSED FINAL documents on "Essential Principles of Safety and Performance of IVD Medical Devices”