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Posted 14 November 2013 | By Alexander Gaffney, RAC,
The Asian Harmonization Working Party (AHWP) has announced the release of two proposed regulatory documents for public comment, one on adverse event reporting for medical devices and the other on the quality management system used by device manufacturers.
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.
The group's 13 November 2013 announcement, a call for comments, related to two documents: Adverse Event Reporting Guidance for the Medical Device Manufacturer or its Authorized Representative, and Quality management system - Medical devices - Nonconformity Grading System for Regulatory Purposes and Information Exchange.
The former is intended to establish the conditions under which an adverse event should be reported to the relevant regulatory authority and when. According to the guidance, "typical events" include device malfunctions, deterioration in characteristics or performance, inadequate design, inadequate manufacture, significant public health concerns, and inaccurate labeling resulting in serious injury or death.
The devices should be associated with the adverse event, though AHWP concedes this "judgment may be difficult when there are multiple devices and drugs involved," but says that a presumption of association should be made in "complex situations."
Adverse events should also be reported to relevant authorities in cases where harm was narrowly averted, indicating that a less-favorable outcome might happen in the future.
The document also contains examples of when adverse events should not be reported, such as when an event is caused by the underlying disease the device is trying to treat or if a defect occurs during pre-insertion testing as specified under the device's instructional labeling.
The latter document pertains to the quality management system used by device companies, and in particular the grading system for nonconformities.
The document should already be familiar to most within the device regulatory community, as it was produced by the Global Harmonization Task Force (GHTF), a now-defunct global harmonization body for device regu
The guidance had originally been developed in partnership between GHTF and AHWP, and the latter has apparently endeavored to keep it updated since its 2012 final release.
The document introduces a standardized format for grading nonconformities, involving a grading matrix (first or repeat occurrence; indirect or direct impact on quality) and a final assessment scale of one (least-bad) to five (worst). Extensive examples of what constitutes each grade are given within the guidance.
Comments on both documents are due by 26 November 2013.
AHWP: Nonconformity Guidance
AHWP: Adverse Event Guidance