The Global Harmonization Task Force (GHTF) is a voluntary group of representatives from medical device regulatory authorities and the regulated industry. According to the website the purpose of the GHTF is to “encourage convergence in regulatory practices related to ensuring the safety, effectiveness / performance and quality of medical devices, promoting technological innovation and facilitating international trade. The primary way in which this purpose is accomplished is via the publication and dissemination of harmonized documents on basic regulatory practices.”
In April, the group proposed a new document intended for regulatory authorities and auditing organizations. The document introduces a standardized Nonconformity Grading System for regulatory purposes with forms providing consistent audit information in order to enable exchange among regulatory authorities from various countries. This grading system would provide a risk-based approach to auditing and detail the minor and major findings of an audit. The regulatory authorities would then be able to use the audit information within their jurisdiction.
The proposed main form to be shared between regulators is titled: “Regulatory Audit Information Exchange Form,” which can be summarized in three main parts:
- List of nonconformities from the audit report - Provides insight into the context and relevance of each nonconformity listed on the exchange form.
- Details of the calculation of the Nonconformity Grading System - Details how the final nonconformity grade was obtained, specifically against ISO 13485:2003. The use of this section of the exchange form provides transparency in the calculation process.
- Medical device country specific regulatory requirements - To help identify regulatory nonconformities that are specific to a particular country; as in the US, which include regulations outside the scope of ISO.
GHTF’s document is full of illustrations and examples to help explain the forms and ideas proposed. In the U.S. most preparations for audits include utilizing the FDA’s BIMO checklist to analyze strengths and weakness in areas of compliance. Could this change the auditing style of medical devices in the US?
We are interested to hear your thoughts on this new audit system. Please feel free to comment below.
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