No.

WG

Work Plan

Status

1

WG3,5

Clinical evidence and clinical evaluation requirements for software as a medical device

To be  approved in 2024 TC Meeting

2

WG1

Good Reliance Practices for MD, IVD, and SaMD throughout the life cycle

3

AI-related review guidance development

4

Guidance on Safety & Performance Checklist

5

WG2

AHWP/WG2-F001:2018- Labelling for In Vitro Diagnostic Medical Devices

6

WG3

AI/ML based SaMD change submission requirement –Comparison of requirements from key jurisdictions

7

WG4

Guidelines for Adverse Event Reporting of Percutaneous Coronary Intervention (PCI) devices for the Medical Device Manufacturer or its Authorized Representative;

8

Adverse Event Reporting Guidance for the Medical Device Manufacturer or its Authorized Representatives;

9

Medical Device Adverse Event (AE) Report Form;

10

WG7

Guidance for control of sterile and implantable medical device

11

Revise Guidance for Auditing Supplier to Medical Device Manufacturers (to replace GHWP/WG6/P003:2023) – focus on setting up procedure & implementation of supplier audit

12

Revise Comparison study of new ISO13485 vs. QMS requirements in GHWP member economies (extend to cover implementation and upper regulations)

13

(GHWP TCWG7/D001:2023) Comparison study of new ISO13485 vs. QMS requirements in GHWP member economies

14

(GHWP TCWG7/D002:2022) Guidance Document for Medical Device Organizations - Product Localization for Manufacturing and Importation 

15

(WG7/NWIP: 2023) Guidance for Remote Inspection

16

(WG7/NWIP: 2023) Guidance for Quality Agreement of Medical Devices Contract Manufacturing

17

WG8

Guidance on the Validation of Processes for Production.

18

Whitepaper on Role of Standards in Demonstration of Safety and Performance

19

Guidelines on development of GHWP Documents - Part 1: Procedure for development

20

Guidelines on development of GHWP Documents - Part 2: Structure and drafting

21

WG9

UDI – Data Elements

22

Creation and Placement of UDI