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Nations May Soon Have Out-of-the-Box Auditing Option

Erik Swain

May 1, 2008

3 Min Read
Nations May Soon Have Out-of-the-Box Auditing Option


An International Accreditation Forum (IAF) working group is developing a program that would accredit conformity assessment bodies that perform audits. This move is significant because it could allow developing nations to have a medical device–plant auditing system without reinventing the audit process.

In fact, says the working group's chairman, if the United States adopts the program, it could allow FDA to close the gap on inspection of foreign plants. (The Government Accountability Office [GAO] recently released a report stating that FDA only audits foreign medical device plants once every 27 years on average.) But it is unlikely that FDA would relinquish too much of its inspection duties.

The Global Harmonization Task Force (GHTF) has been working with developing countries to implement medical device regulatory systems. But if each of these countries requires its own inspection, that could drive small companies' products from those markets, says Grant Ramaley, chair of IAF's Global Medical Device Conformity Assessment System (GMDCAS) working group.

“As it stands now, it is an eventuality that more countries will inadvertently suffer from loss of legal access to medical devices” when they try to implement their own regulations, says Ramaley. He is also director of regulatory affairs at Aseptico Inc. (Woodinville, WA) and chairman of the Dental Trade Alliance's Regulatory Affairs and Standards Committee.

For example, he says, “Aseptico sold $17,000 worth of product to Chile in 2005. This is typical for most small manufacturers. Would we then invite a Chilean audit, simply to keep such a tiny market open? The answer is a resounding no. Multiply that ‘no' among small medical device manufacturers, and you can envision the healthcare crisis that would result [in these markets].”

It does not make sense for manufacturers to submit to separate audits for every single country in which they want to sell, especially if most of those nations are using ISO 13485 as the basis for their national standard, he explains. At the same time, he says, conformity assessment bodies that perform the audits are not interested in spending the time and money to maintain individual accreditations with so many smaller countries.

A better way, he says, would be to have one inspection cover a plant's quality system compliance, which would determine its suitability to export to multiple countries. In turn, one accreditation would enable third-party conformity assessment bodies to perform duties for multiple countries.

And that is what the GMDCAS is attempting to accomplish. Members of the working group held their second meeting in March. It will be at least another year before anything is published, Ramaley says. Both the GHTF and AdvaMed have endorsed the creation of a single quality management certification accepted everywhere.

Ramaley even contacted Marcia Crosse, author of the GAO report. He wanted to get her feedback on the working group's undertaking, because FDA has been unable to inspect so many foreign plants.

“There is a definite benefit to public health if we can have inspections regularly,” he says. The current FDA inspection system is failing on that front. Can the GMDCAS point to a better way?

Copyright ©2008 Medical Device & Diagnostic Industry

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