Jun 22, 2022 | Basic page

Objectives

  1. WHO Global Model Regulatory Framework (GMRF) for Medical Devices and IVDs recommendations adopted by members.

  2. Regional, continental, and internationally harmonized technical guidelines relating to Medical Devices and IVD Medical Devices developed and implemented

  3. Increased awareness of medical device regulation and established legal frame work and introduction of regulatory framework by more countries including adoption of GHTF definition, risk classification, registration of importers, distributors, listing of medical devices, post market surveillance, establish essential principles of safety and performance, establish basis for reliance and recognition, requirements for manufacturers, declaration of conformity and requirements for labels and advertisement.

  4. Improved collaboration, convergence, work sharing and networking amongst members. For example: - harmonized registration requirements, acceptance of quality management system auditing reports, shared point for adverse events reports etc.

  5. Collaboration with other harmonization initiatives such asGHWP, IMDRF, ASEAN, APEC and any other interested partner enhanced.