GHTF Adds New Guidance Documents in September

The Global Harmonization Task Force (GHTF) issues guidance documents to help achieve greater uniformity between national medical device regulatory systems. The GHTF structure includes both Study Groups (SG) and Ad Hoc Working Groups (AHWG) in specific areas:

  • SG1 – Premarket Evaluation
  • SG2 – Post-Market Surveillance/Vigilance
  • SG3 – Quality Systems
  • SG4 – Auditing
  • SG5 – Clinical Safety/Performance
  • AHWG – Global Model
  • AHWG – Unique Device Identification
  • AHWG – Regulatory Change Management

In September, 2011 GHTF issued some documents of interest described below.

SG1 – Premarket Evaluation

  • Label and Instructions for Use for Medical Devices (Final)

SG5 – Clinical Safety/Performance

  • Clinical Evidence for IVD Medical Devices – Key Definitions and Concepts (Proposed)
  • Clinical Evidence for IVD Medical Devices – Scientific Validity Determination and Performance Evaluation (Proposed)

AHWG – Unique Device Identification

  • Unique Device Identification (UDI) System for Medical Devices (Final)

You can download these documents from at no charge. The proposed documents have a comment period and the GHTF solicits comments.