Global standard proposed for regulating medical device makers on quality

The Global Harmonization Task Force has come out with a new document that, it hopes, will help standardize the way the world’s top healthcare regulation authorities, including the FDA, handle nonconformities during audits of medical device manufacturers’ quality management systems (QMS).

The manuscript, which is open for comment until June 22, introduces its non-binding guidance by explaining that, currently, regulatory bodies vary from one to the next in the weight they assign the significance of QMS nonconformities.

“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,” the proposed document reads.

The task force’s new grading system would offer a risk-based approach that would not only streamline regulators’ work in this area but also facilitate “global information exchange” among and between the task force’s member countries.

The manuscript lays out tentative guidance on grading and writing up the nonconformities, along with “escalation rules” to address higher-risk issues that have the potential to affect product safety and performance.

“The regulatory authorities can determine how the audit information will be utilized within their jurisdiction,” states the document. “Regulatory authorities may also consider other data sources in addition to the outcome of the regulatory audits such as product evaluations, recalls [and] vigilance reports … for regulatory oversight.”

The Global Harmonization Task Force is a voluntary group of representatives from regulatory bodies as well as medical-device businesses and associations around the world. Its chairmanship alternates among its five founding members—the U.S., the European Union, Canada, Japan and Australia. The current chair is Japan.