Regulatory Focus™ > News Articles > AHWP Unveils Four Guidance Documents Aimed at Regulation of IVDs

AHWP Unveils Four Guidance Documents Aimed at Regulation of IVDs

Posted 15 November 2013 | By Alexander Gaffney, RAC

The Asian Harmonization Working Party (AHWP), a medical device-focused regulatory harmonization group, has released an additional four documents for consultation and public comment, just days after releasing two other documents.

Background

AHWP is an international organization focused on harmonizing medical device regulation and policies across its 23 member countries. While those countries are primarily in Asia-China, India, Saudi Arabia, Singapore, etc-the group also includes some outside the Asia region like South Africa and Chile.

On 13 November, the group released two documents for consultation. The first, Adverse Event Reporting Guidance for the Medical Device Manufacturer or its Authorized Representative, seeks to standardize the definition of "Adverse event" throughout AHWP's member countries. The second, Quality management system - Medical devices - Nonconformity Grading System for Regulatory Purposes and Information Exchange, provides a standardized method of grading nonconformities found during the audit of a manufacturer's quality system.

New Guidance

On 15 November, the group released an additional four documents for consultation.

The first, AHWP Regulatory Framework for IVD Medical Devices, is meant to provide a basic framework by which all AHWP member countries can regulate in vitro diagnostic devices, and contains recommendations on how to set up those systems in regions where no framework yet exists.

A second document, "Essential Principles of Safety and Performance of IVD Medical Devices," expands on the first, offering recommendations on how to regulate the design and manufacture of IVDs so that the end product is safe and effective while being minimally burdensome on the manufacturer. The document is based on the final GHTF/SG1/N68:2012 published by the Global Harmonization Task Force (GHTF) before it disbanded in December 2012.

A third document, Summary Technical Documentation (STED) for Demonstrating Conformity to the Essential Principles of Safety and Performance of In Vitro Diagnostic Medical Devices, provides recommendations on the content of a STED application, with the end goal of making them be acceptable in all AHWP member countries. Harmonization in this area would reduce the costs to the manufacturer and accelerate patient access to IVDs, AHWP wrote.

The fourth and final document, "Comparison between the GHTF Summary Technical Documentation (STED) formats for Medical Devices and In Vitro Diagnostic Medical Devices and the Common Submission Dossier Template (CSDT) Format," is intended to provide insight on which of the two standards-STED or CSDT-should be used in the submission of an IVD application to a regulatory authority.

Comments on all documents are due by 26 November 2013.


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