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The Goal of Harmonization is Not Homogeneity

It's no surprise to any device maker that there are myriad inconsistencies in regulatory schemes from country to country. Efforts by the Global Harmonization Task Force (GHTF) to bring these inconsistencies to a minimum have been largely successful. But the work is nowhere near finished. Device manufacturers who are waiting for not just harmonization but blanket uniformity may misunderstand the goals of the GHTF. They are going to be disappointed, explained Paul Brooks, vice president and country manager of BSI PS Healthcare US and a member of the GHTF.

"Our goal is to bring regulatory bodies together, not make them exactly the same," he said during the RAPS Horizons conference, held in late March in San Francisco. Brooks and Michael Gropp, global regulatory strategist for Medtronic, spoke to attendees about the global regulatory environment and how harmonized regulations are being adopted -- or better yet, adapted. "The idea [among manufacturers] is that harmonization is a big bang theory. In reality, verbatim adoption is unlikely," said Gropp. He explained that a convergence model is more likely as countries implement standards such as ISO 13485, and then apply local preferences over that standard. Part of the difficulty is that countries with established regulations do not have flexibility. "It's hard to retroactively harmonize," Gropp said. "Consider how difficult it is to change a law in the United States." Even so, harmonization efforts have had an enormous effect on the regulatory climate and will continue to do so, especially for countries with immature regulatory structures. Countries without prior medical device regulations are likely to apply the standards as they are written, Gropp said. For example, India will soon have a regulatory mechanism in place for manufacturers of medical devices in that country. It is likely that ISO 13485 and other standards will play prominent roles, Brooks said. Ultimately, it is up to an OEM's regulatory staff to understand the regulatory idiosyncracies of each country, Gropp said. They are responsible for understanding and interpreting the directives. A PDF and MP3 of the presentation, "Implications of Global Regulatory Changes," is available on the RAPS Web site. -- Heather Thompson 

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