GHTF Adds New Guidance Documents in October, 2011

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 October 2011 GHTF issued some documents of interest described below.

SG1 – Premarket Evaluation

SG1(PD)/N078R03 Principles of Conformity Assessment for Medical Devices (Draft)

This document, when approved, supersedes GHTF/SG1/N40:2006 which provided guidance on the same topic.

SG1(PD)/N077R04 Principles of Medical Devices Classification (Draft)

This document, when approved, supersedes GHTF/SG1/N15:2006 which provided guidance on the same topic. It has been modified to:

  • clarify the basis of allocating medical devices to one of four classes;
  • change the rule applying to sterilisation and disinfection devices;
  • remove the inconsistency with GHTF/SG1/N011 Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED);
  • add a Section on the reclassification of medical devices; and
  • incorporate changes resulting from the public scrutiny process.

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