Regulatory Focus™ > News Articles > GHTF Proposes New Harmonization of Medical Device Audits

GHTF Proposes New Harmonization of Medical Device Audits

Posted 24 April 2012 | By Alexander Gaffney, RAC 

The Global Harmonization Task Force (GHTF), a medical device-focused regulatory harmonization organization which counts among its members many of the world's top regulatory agencies, announced a new proposed medical device standard aimed at introducing a grading system to be used during regulatory audits by regulatory authorities and auditing organizations.

The proposed document, SG3(PD)/N19: Quality Management System - Medical Devices - Nonconformity Grading System for Regulatory Purposes and Information Exchange, details a "common risk-based approach" known as a Nonconfirmity Grading System (NGS), which assigns a nonconformity grade to the audited entity.

"Currently, the significance of a nonconformity related to a medical device manufacturer's Quality Management System (QMS) may vary between regulatory authorities and auditing organizations," notes GHTF in the document. "All parties will benefit through the use of a standardized and transparent grading system of QMS nonconformities to communicate the findings of a regulatory audit, building the confidence necessary for the potential mutual acceptance of the results of a regulatory audit."

To accomplish this, GHTF's document, released 23 April 2012, introduces a Regulatory Audit Information Exchange Form (RAIEF) that includes three parts:

  • a list of regulatory nonconformities, including "sufficient insight" into how each one deviates from regulations, including ISO 13485:2003
  • details of how each Nonconformity Grading System was calculated gainst ISO 13485:2003 regulations
  • regulatory deviances that are specific to a particular country and outside of the scope of ISO 13485:2003

SG3(PD)/N19 goes on to describe a system of grading, how to evaluate the impact of nonconformities through a Nonconformity Grading Matrix, how regulatory authorities can use the information obtained, and provide examples of how to word RAIEF forms.

Comments on the proposed document are due by 22 June 2012.


Read more:

GHTF - SG 3 Proposed Documents

SG3(PD)/N19: Quality Management System - Medical Devices - Nonconformity Grading System for Regulatory Purposes and Information Exchange

Read all Regulatory Focus Stories About the GHTF

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