15 Agents of Change in Medtech: No. 13 Harmonization

No. 13: Harmonization As the medical device business has gone global, medtech companies seeking to place their products in markets throughout the world have found themselves ensnared in a complex web of global regulations. Different rules in different countries mean device makers are forced to jump through different—though sometimes similar— hoops in each market where they wish to sell their products.

But several groups are working to change that by streamlining medical device regulatory processes worldwide. They’re making progress, too.

The Asia-Pacific Economic Cooperation’s Life Sciences Innovation Forum Regulatory Harmonization Steering Committee has a goal of achieving regulatory convergence for medical devices and pharmaceuticals by 2020. The committee includes members from FDA, Health Canada, CFDA, and Japan’s Ministry of Health, Labour, and Welfare, as well as other Asian regulatory bodies.

Another group, the Asian Harmonization Working Party, is comprised of experts from the industry and regulatory authorities hailing from 23 member economies in Asia, the Middle East, Africa, and South America. The group encourages its members to adopt a harmonized regulatory system and collaborate on everything from a single nomenclature system to a postmarket surveillance framework.

Earlier this year, yet another group, the International Medical Device Regulators Forum, made up of regulators from eight countries, launched a pilot of its Medical Device Single Audit Program (MDSAP). FDA, Health Canada, Brazils ANVISA, and Australia’s Therapeutic Goods Association will accept MDSAP audit reports in lieu of their own inspections. The operational program is expected to roll out in 2017.

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Meet more agents of change in medtech at the MD&M East tradeshow and conference in New York City June 9–12, 2014.



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