The 2nd GHWP (Guangzhou) Academy Training Notice

(1st round notice)

For your kind perusal, please find attached the Proposed Document 'Amendment 11 to GHWP House Rules on Descriptions of Secretariat Team'.

Kindly send your comments with the template attached to the GHWP Secretariat (secretariat@ghwp.info) on or before 8 November 2024 (Friday) 12:00noon (GMT+8). Thank you.

For your kind perusal, please find attached the WG8 Proposed Document 'Guidelines on Development of GHWP Documents - Part 2: Structure and Drafting'.

For your kind perusal, please find attached the WG8 Proposed Document 'Guidelines on Development of GHWP Documents - Part 1 Procedure for Development'.

For your kind perusal, please find attached the WG7 Proposed Document 'Guidance Document for Medical Device Organizations-Product Localisation for Manufacturing and Importation'.

For your kind perusal, please find attached the WG7 Proposed Document 'Comparison Study of new ISO13485 vs. QMS requirements in GHWP member economies'.

For your kind perusal, please find attached the WG3 Proposed Document 'Software as a Medical Device (SaMD) Pre-Market Submission Requirement – Comparison of requirement from Key jurisdictions '.

For your kind perusal, please find attached the Proposed Document 'Amendment 10 to GHWP TOR and House Rules on GHWP Management Committee'.

Kindly send your comments with the template attached to the GHWP Secretariat (secretariat@ghwp.info) on or before 9 November 2024 (Saturday) 12:00noon (GMT+8). Thank you.

For your kind perusal, please find attached the Proposed Document 'Amendment 9 to the Global Harmonization Working Party Terms of Reference and House Rules'.

For your kind perusal, please find attached the WG4 Proposed Document 'Guidelines for Adverse Event Reporting of Percutaneous Coronary Intervention (PCI) devices for the Medical Device Manufacturer or its Authorized Representative'.