Events Announcements

For endorsement at the 21st AHWP Meeting-PROPOSED FINAL document on "Guidance on Regulatory Practices for Combination Products"

After consolidating the comments received from GHWP members by 18 Nov 2016, the PROPOSED document on "Guidance on Regulatory Practices for Combination Products" developed by GHWP WG1 has become the captured PROPOSED FINAL document, for the endorsement at the 21st GHWP Meeting in Cebu.

Read more about For endorsement at the 21st AHWP Meeting-PROPOSED FINAL document on "Guidance on Regulatory Practices for Combination Products"

For endorsement at the 21st AHWP Meeting-PROPOSED FINAL document on "Submission Dossier for Demonstrating Conformity to the Essential Principles of Safety and Performance of In Vitro Diagnostic Medical Devices"

Read more about For endorsement at the 21st AHWP Meeting-PROPOSED FINAL document on "Submission Dossier for Demonstrating Conformity to the Essential Principles of Safety and Performance of In Vitro Diagnostic Medical Devices"

For endorsement at the 21st AHWP Meeting-PROPOSED FINAL document on "Principles of Conformity Assessment for In Vitro Diagnostic (IVD) Medical Devices"

After consolidating the comments received from GHWP members by 18 Nov 2016, the PROPOSED document on "Principles of Conformity Assessment for In Vitro Diagnostic (IVD) Medical Devices" developed by GHWP WG2 has become the captured PROPOSED FINAL document, for the endorsement at the 21st GHWP Meeting in Cebu.

Read more about For endorsement at the 21st AHWP Meeting-PROPOSED FINAL document on "Principles of Conformity Assessment for In Vitro Diagnostic (IVD) Medical Devices"

For endorsement at the 21st AHWP Meeting-PROPOSED FINAL document on "Principles of In Vitro Diagnostic (IVD) Medical Devices Classification"

After consolidating the comments received from GHWP members by 18 Nov 2016, the PROPOSED document on "Principles of In Vitro Diagnostic (IVD) Medical Devices Classification" developed by GHWP WG2 has become the captured PROPOSED FINAL document, for the endorsement at the 21st GHWP Meeting in Cebu.

Read more about For endorsement at the 21st AHWP Meeting-PROPOSED FINAL document on "Principles of In Vitro Diagnostic (IVD) Medical Devices Classification"

For endorsement at the 21st AHWP Meeting-PROPOSED FINAL document on "Post Market Resource Center"

After consolidating the comments received from GHWP members by 18 Nov 2016, the PROPOSED document on "Post Market Resource Center" developed by GHWP WG4 has become the captured PROPOSED FINAL document, for the endorsement at the 21st GHWP Meeting in Cebu.

Read more about For endorsement at the 21st AHWP Meeting-PROPOSED FINAL document on "Post Market Resource Center"

For endorsement at the 21st AHWP Meeting-PROPOSED FINAL document on "Guidelines for Adverse Event Reporting of Percutaneous Coronary Intervention (PCI) Devices for the Medical Device Manufacturer or Its Authorized Representative"

Read more about For endorsement at the 21st AHWP Meeting-PROPOSED FINAL document on "Guidelines for Adverse Event Reporting of Percutaneous Coronary Intervention (PCI) Devices for the Medical Device Manufacturer or Its Authorized Representative"

For endorsement at the 21st AHWP Meeting-PROPOSED FINAL document on "AHWP Safety Alert Dissemination System (SADS)"

After consolidating the comments received from GHWP members by 18 Nov 2016, the PROPOSED document on "GHWP Safety Alert Dissemination System (SADS)" developed by GHWP WG4 has become the captured PROPOSED FINAL document, for the endorsement at the 21st GHWP Meeting in Cebu.

Read more about For endorsement at the 21st AHWP Meeting-PROPOSED FINAL document on "AHWP Safety Alert Dissemination System (SADS)"

For endorsement at the 21st AHWP Meeting-PROPOSED FINAL document on "Competence and Training Requirements for Auditing Organizations"

After consolidating the comments received from GHWP members by 18 Nov 2016, the PROPOSED document on "Competence and Training Requirements for Auditing Organizations" developed by GHWP WG6 has become the captured PROPOSED FINAL document, for the endorsement at the 21st GHWP Meeting in Cebu.

Read more about For endorsement at the 21st AHWP Meeting-PROPOSED FINAL document on "Competence and Training Requirements for Auditing Organizations"

For endorsement at the 21st AHWP Meeting-PROPOSED FINAL document on "Requirements for Medical Device Auditing Organizations for Regulatory Authority Recognition"

After consolidating the comments received from GHWP members by 18 Nov 2016, the PROPOSED document on "Requirements for Medical Device Auditing Organizations for Regulatory Authority Recognition" developed by GHWP WG6 has become the captured PROPOSED FINAL document, for the endorsement at the 21st GHWP Meeting in Cebu.

Read more about For endorsement at the 21st AHWP Meeting-PROPOSED FINAL document on "Requirements for Medical Device Auditing Organizations for Regulatory Authority Recognition"

For endorsement at the 21st AHWP Meeting-PROPOSED FINAL document on "MDSAP: Overview of Auditing Organization Assessment and Recognition Decision Related Processes"

After consolidating the comments received from GHWP members by 18 Nov 2016, the PROPOSED document on "MDSAP: Overview of Auditing Organization Assessment and Recognition Decision Related Processes" developed by GHWP WG6 has become the captured PROPOSED FINAL document, for the endorsement at the 21st GHWP Meeting in Cebu.

Read more about For endorsement at the 21st AHWP Meeting-PROPOSED FINAL document on "MDSAP: Overview of Auditing Organization Assessment and Recognition Decision Related Processes"